Advanced Solid Tumors
Conditions
Keywords
Immunotherapy, IL-2, Interleukin-2, Solid tumors, Melanoma, Renal cell carcinoma, Non-small-cell lung cancer, Squamous cell carcinoma of the head and neck, in combination with pembrolizumab
Brief summary
To better understand the safety and tolerability of ALKS 4230 in humans
Detailed description
To investigate the safety and tolerability of ALKS 4230, determine the recommended Phase 2 dose (RP2D) and assess anti-tumor activity in Monotherapy and ALKS 4230 in Combination with pembrolizumab.
Interventions
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle
Sponsors
Study design
Eligibility
Inclusion criteria
* For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has a diagnosis of melanoma or renal cell carcinoma * All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies * Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as a target lesion * Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months * Subject must have adequate hematologic reserve * Subjects must have adequate liver function * Subjects must have adequate kidney function * Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery * Subjects who have received investigational agents must wait at least 4 weeks * Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as \>45 years of age and without a menstrual period for 12 consecutive months * Meets contraceptive requirements defined in the protocol * Additional criteria may apply
Exclusion criteria
* Subject is currently pregnant or breastfeeding, or is planning to become pregnant during the study * Subjects with an active infection or with a fever \>/= 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1 * Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable * Subjects have a mean QT interval corrected by the Fridericia Correction formula value of \>470 msec (in females) or \>450 msec (in males) * Subjects with known hypersensitivity to any components of ALKS 4230 * Subjects with known hypersensitivity to any components of pembrolizumab (for patients in combination arm only) * Subjects who require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted * Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy * Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study * The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis * Subjects with dyspnea at rest of requiring oxygen therapy * Subjects active autoimmune disease requiring systemic treatment within the past 30 days * Subjects who received radiotherapy within the last 4 weeks before start of study treatment administration with the exception of limited field palliative radiotherapy * Subjects who have received systemic immunomodulatory agents within 28 days prior to C1D1. * Subjects who have received administration of a live, attenuated vaccine within 4 weeks of Cycle 1, Day1. * Prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant recipients * Subjects who have received prior IL-2 based or IL-15 based cytokine therapy * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days) | DLT was defined by any of following events possibly, probably, or definitely related to ALKS 4230: Grade 4 neutrophil count decreased (neutropenia); Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; Thrombocytopenia; Any Grade 3 cardiac or central nervous system toxicity; Liver transaminase elevation higher than 8\*upper limit of normal (ULN) or total bilirubin higher than 6\*ULN; Grade 4 hypoalbuminemia; Fever more than (\>) 40 degree Celsius (°C) sustained for \>24 hours; Hypotension required the use of pressors or prolonged hospitalization (\>48 hours) for hypotension requiring medical intervention; Grade 3 or higher electrolyte abnormalities; Increase in amylase or lipase; Grade 3 or higher nausea, vomiting, or diarrhea; Any other Grade 4 nonhematologic toxicity or any other Grade 3 non-hematologic toxicity; Any other toxicity or adverse event (AE) not defined above that resulted in participant removal from the study or discontinuation of dosing by the Investigator. |
| Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C) | TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. |
| Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C) | TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. Severity was graded according to the National Cancer Institute (NCI) CTCAE (version 4.03) where, Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. As planned, Grades 1 and 2 were combined for reporting. |
| Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | From first dose of study drug up to 40.3 months for Part B and up to 50.5 months for Part C | ORR rate was defined as the percentage of participants with objective evidence of CR or PR based on RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | From first dose of study drug up to 9 months (for Part A); up to 40.3 months (for Part B); up to 50.5 months (for Part C) | Overall proportion was calculated as: Number of participants (overall positive)/total number of participants in the cohort. Overall positive: Participants with at least 1 treatment-emergent ADA positive sample at any time during the treatment period. |
| Parts A, B, and C: Immune ORR (iORR) Based on Immune RECIST (iRECIST) | From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C | iORR was defined as the percentage of participants with objective evidence of immune CR (iCR) or immune PR (iPR) based on iRECIST guidelines. |
| Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C | Disease control rate was defined as the percentage of participants with objective evidence of CR, PR, or SD based on RECIST v.1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Parts A, B, and C: Immune DCR (iDCR) Based on iRECIST v1.1 | From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C | iDCR was defined as the percentage of participants with objective evidence of iCR, iPR (where iCR or iPR required confirmation), or immune stable disease (iSD) (where the iSD requires to occur at Cycle 4 or later). |
| Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | From the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C) | Duration of response was defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Parts B, and C: Immune DOR (iDOR) Based on iRECIST | From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C | iDOR was defined as the time from the first documentation of response (iCR or iPR) to the first documentation of objective tumor progression (immune confirmed progressive disease \[iCPD\]) or death due to any cause based on iRECIST. |
| Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose | Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts. |
| Part B and Part C Cohorts C5, C6, C7: Immune DRR (iDRR) Based on iRECIST | From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C | iDRR was defined as the percentage of participants with an objective response (complete or partial response per iRECIST) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug. |
| Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1 | From first dose of study drug up to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C) | Progression-free survival was defined as the time from the first dose of nemvaleukin to the first documentation of objective tumor progression or death due to any cause. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Part B and Part C Cohorts C5, C6, C7: Immune PFS (iPFS) | From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C | iPFS was defined as the time from the first dose of study medication to the first documentation of objective tumor progression based on iRECIST (immune confirmed progressive disease \[iCPD\]) or death due to any cause. |
| Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Cycle 1 Day 1 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C) | — |
| Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | Cycle 1 Days 1 and 5; Cycle 2 Days 1 and 5 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts) | — |
| Part B and Part C Cohorts C5, C6, C7: Durable Response Rate (DRR) Based on RECIST v.1.1 | From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C | DRR was defined as the percentage of participants with an objective response (complete or partial response per RECIST 1.1) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug. |
| Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose | Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts. |
| Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose | Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts. |
| Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose | Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts. |
Countries
Australia, Belgium, Canada, Poland, South Korea, Spain, United States
Participant flow
Recruitment details
The study was conducted at 47 investigative sites in the United States, Spain, Canada, South Korea, Australia, Belgium, and Poland.
Pre-assignment details
A total of 243 participants were enrolled in this 3-part study (Parts A, B and C) to receive nemvaleukin alfa (ALKS 4230) either as monotherapy or in combination with pembrolizumab. Selected participants (43) enrolled in Monotherapy Parts A and B, and who did not demonstrate clinical benefit were eligible to rollover to Combination Therapy Part C and were rolled over in Part C, Cohort 4.
Participants by arm
| Arm | Count |
|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg Participants with advanced solid tumors received nemvaleukin alfa 1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg Participants with advanced solid tumors received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg Participants with advanced solid tumors received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 12 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg Participants with advanced solid tumors received nemvaleukin alfa 8 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg Participants with advanced solid tumors received nemvaleukin alfa 10 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 7 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 47 |
| Part B, Dose Expansion, RCC: Nemvaleukin 6 Alfa mcg/kg Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria. | 27 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg Participants with any tumor type received nemvaleukin alfa 1 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the Participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. | 3 |
| Part C, Combination Therapy, Cohort 1 + Safety Run-in: Nemvaleukin Alfa 3mcg/kg +Pembrolizumab 200mg Participants with PD-1/L1 unapproved tumor types (PD-1/L1 treatment naive) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. The Safety Run-in for nemvaleukin alfa 3 mcg/kg was combined with Cohort 1 of Part C due to same dosing level and regimen. | 42 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants with PD-1/L1 approved tumor types (PD-1/L1 treatment pretreated) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. | 26 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants with PD-1/L1 approved tumor types (PD-1/L1 treatment naive) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. | 26 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants rollover from Parts A or B received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. | 43 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. | 3 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg Participants with NSCLC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. | 21 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg Participants with SCCHN received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. | 2 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A | Adverse Event | 1 | 0 | 1 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Clinical Progression | 1 | 0 | 2 | 1 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Death | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Progressive Disease | 3 | 3 | 3 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Protocol Deviation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Rolled Over to Part C, Cohort 4 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Withdrawal by Subject | 0 | 0 | 0 | 1 | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B | Progressive Disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B | Rolled Over to Part C, Cohort 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 26 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part C | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 1 | 0 | 0 | 0 |
| Part C | Clinical Progression | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 1 | 0 | 0 | 0 |
| Part C | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 5 | 6 | 8 | 1 | 8 | 1 |
| Part C | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 3 | 0 | 0 | 0 |
| Part C | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 |
| Part C | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part C | Progressive Disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 13 | 2 | 0 | 1 | 0 | 0 | 0 |
| Part C | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 15 | 13 | 21 | 0 | 12 | 1 |
Baseline characteristics
| Characteristic | Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Part B, Dose Expansion, RCC: Nemvaleukin 6 Alfa mcg/kg | Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Part C, Combination Therapy, Cohort 1 + Safety Run-in: Nemvaleukin Alfa 3mcg/kg +Pembrolizumab 200mg | Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Part A 18 to 64 years | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 28 Participants |
| Age, Customized Part A 65 to 84 years | 1 Participants | 2 Participants | 4 Participants | 8 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 18 Participants |
| Age, Customized Part A > 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Part B 18 to 64 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 20 Participants | 10 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 30 Participants |
| Age, Customized Part B 65 to 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 27 Participants | 17 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 44 Participants |
| Age, Customized Part B > 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants |
| Age, Customized Part C 18 to 64 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 30 Participants | 20 Participants | 0 Participants | 15 Participants | 18 Participants | 1 Participants | 11 Participants | 1 Participants | 96 Participants |
| Age, Customized Part C 65 to 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 12 Participants | 6 Participants | 0 Participants | 11 Participants | 25 Participants | 2 Participants | 9 Participants | 1 Participants | 69 Participants |
| Age, Customized Part C > 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Part A Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | — | — | — | — | — | 1 Participants | — | — | — | — | — | 2 Participants |
| Ethnicity (NIH/OMB) Part A Not Hispanic or Latino | 4 Participants | 7 Participants | 8 Participants | 12 Participants | 3 Participants | 6 Participants | — | — | — | — | — | 4 Participants | — | — | — | — | — | 44 Participants |
| Ethnicity (NIH/OMB) Part A Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — | — | — | 0 Participants | — | — | — | — | — | 0 Participants |
| Ethnicity (NIH/OMB) Part B Hispanic or Latino | — | — | — | — | — | — | 0 Participants | 1 Participants | — | — | — | — | — | — | — | — | — | 1 Participants |
| Ethnicity (NIH/OMB) Part B Not Hispanic or Latino | — | — | — | — | — | — | 47 Participants | 26 Participants | — | — | — | — | — | — | — | — | — | 73 Participants |
| Ethnicity (NIH/OMB) Part B Unknown or Not Reported | — | — | — | — | — | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | 0 Participants |
| Ethnicity (NIH/OMB) Part C Hispanic or Latino | — | — | — | — | — | — | — | — | 0 Participants | 1 Participants | 1 Participants | — | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Part C Not Hispanic or Latino | — | — | — | — | — | — | — | — | 3 Participants | 40 Participants | 25 Participants | — | 24 Participants | 42 Participants | 3 Participants | 20 Participants | 2 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Part C Unknown or Not Reported | — | — | — | — | — | — | — | — | 0 Participants | 1 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Part A American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — | — | — | 0 Participants | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part A Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — | — | — | 0 Participants | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part A Black or African American | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | — | — | — | — | — | 0 Participants | — | — | — | — | — | 4 Participants |
| Race (NIH/OMB) Part A More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — | — | — | 0 Participants | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part A Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — | — | — | 0 Participants | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part A Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | — | — | — | — | — | 0 Participants | — | — | — | — | — | 1 Participants |
| Race (NIH/OMB) Part A White | 4 Participants | 6 Participants | 8 Participants | 10 Participants | 2 Participants | 6 Participants | — | — | — | — | — | 5 Participants | — | — | — | — | — | 41 Participants |
| Race (NIH/OMB) Part B American Indian or Alaska Native | — | — | — | — | — | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part B Asian | — | — | — | — | — | — | 5 Participants | 1 Participants | — | — | — | — | — | — | — | — | — | 6 Participants |
| Race (NIH/OMB) Part B Black or African American | — | — | — | — | — | — | 0 Participants | 1 Participants | — | — | — | — | — | — | — | — | — | 1 Participants |
| Race (NIH/OMB) Part B More than one race | — | — | — | — | — | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part B Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part B Unknown or Not Reported | — | — | — | — | — | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) Part B White | — | — | — | — | — | — | 42 Participants | 25 Participants | — | — | — | — | — | — | — | — | — | 67 Participants |
| Race (NIH/OMB) Part C American Indian or Alaska Native | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part C Asian | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 1 Participants | — | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Part C Black or African American | — | — | — | — | — | — | — | — | 0 Participants | 7 Participants | 3 Participants | — | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 15 Participants |
| Race (NIH/OMB) Part C More than one race | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part C Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Part C Unknown or Not Reported | — | — | — | — | — | — | — | — | 0 Participants | 1 Participants | 2 Participants | — | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Part C White | — | — | — | — | — | — | — | — | 3 Participants | 34 Participants | 20 Participants | — | 22 Participants | 40 Participants | 3 Participants | 18 Participants | 2 Participants | 142 Participants |
| Sex: Female, Male Part A Female | 1 Participants | 0 Participants | 4 Participants | 7 Participants | 2 Participants | 4 Participants | — | — | — | — | — | 1 Participants | — | — | — | — | — | 19 Participants |
| Sex: Female, Male Part A Male | 3 Participants | 7 Participants | 4 Participants | 5 Participants | 1 Participants | 3 Participants | — | — | — | — | — | 4 Participants | — | — | — | — | — | 27 Participants |
| Sex: Female, Male Part B Female | — | — | — | — | — | — | 22 Participants | 3 Participants | — | — | — | — | — | — | — | — | — | 25 Participants |
| Sex: Female, Male Part B Male | — | — | — | — | — | — | 25 Participants | 24 Participants | — | — | — | — | — | — | — | — | — | 49 Participants |
| Sex: Female, Male Part C Female | — | — | — | — | — | — | — | — | 1 Participants | 28 Participants | 12 Participants | — | 13 Participants | 18 Participants | 1 Participants | 7 Participants | 1 Participants | 81 Participants |
| Sex: Female, Male Part C Male | — | — | — | — | — | — | — | — | 2 Participants | 14 Participants | 14 Participants | — | 13 Participants | 25 Participants | 2 Participants | 14 Participants | 1 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 7 | 0 / 8 | 1 / 12 | 0 / 3 | 3 / 7 | 7 / 47 | 7 / 27 | 0 / 3 | 7 / 42 | 7 / 26 | 8 / 26 | 8 / 43 | 1 / 3 | 8 / 21 | 1 / 2 |
| other Total, other adverse events | 5 / 5 | 4 / 4 | 7 / 7 | 8 / 8 | 12 / 12 | 3 / 3 | 7 / 7 | 46 / 47 | 27 / 27 | 3 / 3 | 42 / 42 | 26 / 26 | 25 / 26 | 38 / 43 | 3 / 3 | 21 / 21 | 2 / 2 |
| serious Total, serious adverse events | 2 / 5 | 0 / 4 | 2 / 7 | 3 / 8 | 5 / 12 | 0 / 3 | 5 / 7 | 11 / 47 | 12 / 27 | 0 / 3 | 19 / 42 | 10 / 26 | 11 / 26 | 14 / 43 | 2 / 3 | 12 / 21 | 2 / 2 |
Outcome results
Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE)
DLT was defined by any of following events possibly, probably, or definitely related to ALKS 4230: Grade 4 neutrophil count decreased (neutropenia); Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; Thrombocytopenia; Any Grade 3 cardiac or central nervous system toxicity; Liver transaminase elevation higher than 8\*upper limit of normal (ULN) or total bilirubin higher than 6\*ULN; Grade 4 hypoalbuminemia; Fever more than (\>) 40 degree Celsius (°C) sustained for \>24 hours; Hypotension required the use of pressors or prolonged hospitalization (\>48 hours) for hypotension requiring medical intervention; Grade 3 or higher electrolyte abnormalities; Increase in amylase or lipase; Grade 3 or higher nausea, vomiting, or diarrhea; Any other Grade 4 nonhematologic toxicity or any other Grade 3 non-hematologic toxicity; Any other toxicity or adverse event (AE) not defined above that resulted in participant removal from the study or discontinuation of dosing by the Investigator.
Time frame: Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days)
Population: Safety population included all participants who received at least 1 dose of nemvaleukin alfa or pembrolizumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | 2 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | 3 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) | 1 Participants |
Parts A, B, and C: Number of Participants With TEAEs by Severity Grading
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. Severity was graded according to the National Cancer Institute (NCI) CTCAE (version 4.03) where, Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. As planned, Grades 1 and 2 were combined for reporting.
Time frame: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)
Population: Safety population included all participants who received at least 1 dose of nemvaleukin alfa or pembrolizumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 3 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 2 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 1 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 3 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 3 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 4 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 6 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 2 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 3 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 8 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 1 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 0 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 1 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 2 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 1 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 3 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 1 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 2 Participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 28 Participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 6 Participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 12 Participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 1 Participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 5 Participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 16 Participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 5 Participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 0 Participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 3 Participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 0 Participants |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 4 Participants |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 3 Participants |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 19 Participants |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 16 Participants |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 5 Participants |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 7 Participants |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 14 Participants |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 6 Participants |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 5 Participants |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 15 Participants |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 21 Participants |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 4 Participants |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 1 Participants |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 13 Participants |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 1 Participants |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 1 Participants |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 1 Participants |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 4 Participants |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 1 Participants |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 16 Participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 3 TEAEs | 1 Participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 5 TEAEs | 0 Participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 4 TEAEs | 1 Participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With TEAEs by Severity Grading | Participants With Grade 1 and 2 TEAEs | 0 Participants |
Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product.
Time frame: From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)
Population: Safety population included all participants who received at least 1 dose of nemvaleukin alfa or pembrolizumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 5 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 4 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 7 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 8 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 12 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 3 Participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 7 Participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 46 Participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 27 Participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 3 Participants |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 42 Participants |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 26 Participants |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 26 Participants |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 39 Participants |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 3 Participants |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 21 Participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 2 Participants |
Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
ORR rate was defined as the percentage of participants with objective evidence of CR or PR based on RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose of study drug up to 40.3 months for Part B and up to 50.5 months for Part C
Population: The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 8.7 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 13.6 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 0.0 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 13.9 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 0.0 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 28.6 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 7.7 percentage of participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 66.7 percentage of participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 11.1 percentage of participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 50.0 percentage of participants |
Part B and Part C Cohorts C5, C6, C7: Durable Response Rate (DRR) Based on RECIST v.1.1
DRR was defined as the percentage of participants with an objective response (complete or partial response per RECIST 1.1) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug.
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Population: As pre-specified in statistical analysis plan, this outcome measure of DRR was not summarized and hence, no data was reported in this outcome measure.
Part B and Part C Cohorts C5, C6, C7: Immune DRR (iDRR) Based on iRECIST
iDRR was defined as the percentage of participants with an objective response (complete or partial response per iRECIST) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug.
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Population: No data collection or analysis based on irRC and iRECIST was performed as iRECIST was implemented during the middle of the study conduct to replace irRC. However, no data was collected and analyzed for iRECIST either. Therefore, no data is available to report for this outcome measure.
Part B and Part C Cohorts C5, C6, C7: Immune PFS (iPFS)
iPFS was defined as the time from the first dose of study medication to the first documentation of objective tumor progression based on iRECIST (immune confirmed progressive disease \[iCPD\]) or death due to any cause.
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Population: No data collection or analysis based on irRC and iRECIST was performed as iRECIST was implemented during the middle of the study conduct to replace irRC. However, no data was collected and analyzed for iRECIST either. Therefore, no data is available to report for this outcome measure.
Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1
Progression-free survival was defined as the time from the first dose of nemvaleukin to the first documentation of objective tumor progression or death due to any cause. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From first dose of study drug up to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)
Population: The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1 | 16.14 weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1 | 12.43 weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1 | NA weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1 | 18.64 weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1 | 35.57 weeks |
Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Population: The PK population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least 1 measurable serum concentration of nemvaleukin alfa at any scheduled PK time point. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 2.47 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 32.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 2.52 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 17.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 2.61 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 16.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 2.96 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 53.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 15.3 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 45.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 17.0 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 35.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 14.4 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 23.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 11.5 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 18.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 48.2 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 55.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 69.2 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 50.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 66.5 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 36.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 40.8 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 21.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 195 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 252.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 167 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 51.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 106 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 205.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 274 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 39 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 361 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 50.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 478 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 30.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 557 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 28.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 379 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 46 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 323 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 84.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 616 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 42.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 512 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 35.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 439 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 3.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 312 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 131 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 346 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 47.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 573 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 36.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 719 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 39.7 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 608 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 30.1 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 517 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 44.5 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 287 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 60.9 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 292 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 61.4 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 312 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 40.6 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 723 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 23.2 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 594 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 25.9 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 329 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 45.3 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 56.1 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 12.9 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 84.1 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 39.5 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 56.7 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 18.8 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 52.0 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 18.5 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 248 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 23.4 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 121 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 68.5 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 195 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 50.1 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 120 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 72.3 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 143 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 26.2 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 286 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 22.1 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 235 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 30.8 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 135 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 54.3 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 243 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 41.5 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 158 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 41.6 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 296 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 35 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 134 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 35.4 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 128 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 36.6 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 130 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 40.5 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 212 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 39.6 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 276 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 31.4 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 139 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 53.4 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 222 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 77.2 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 224 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 85 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 153 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 73.4 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 275 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 15 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 698 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 21.7 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 343 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 6.8 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 625 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 12.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 368 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 56.7 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 562 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 33.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 715 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 37.6 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 346 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 43.9 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 1 | 543 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 25 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 1 | 590 hour*nanogram per milliliter (h*ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 1 Day 5 | 393 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 45.8 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa | Cycle 2 Day 5 | 413 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 57.6 |
Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1
Disease control rate was defined as the percentage of participants with objective evidence of CR, PR, or SD based on RECIST v.1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Population: The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 0.0 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 25.0 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 20.0 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 60.0 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 33.3 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 33.3 percentage of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 25.0 percentage of participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 47.8 percentage of participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 50.0 percentage of participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 0.0 percentage of participants |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 30.6 percentage of participants |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 22.7 percentage of participants |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 47.6 percentage of participants |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 46.2 percentage of participants |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 66.7 percentage of participants |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 50.0 percentage of participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1 | 100 percentage of participants |
Parts A, B, and C: Immune DCR (iDCR) Based on iRECIST v1.1
iDCR was defined as the percentage of participants with objective evidence of iCR, iPR (where iCR or iPR required confirmation), or immune stable disease (iSD) (where the iSD requires to occur at Cycle 4 or later).
Time frame: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Population: No data collection or analysis based on irRC and iRECIST was performed as iRECIST was implemented during the middle of the study conduct to replace irRC. However, no data was collected and analyzed for iRECIST either. Therefore, no data is available to report for this outcome measure.
Parts A, B, and C: Immune ORR (iORR) Based on Immune RECIST (iRECIST)
iORR was defined as the percentage of participants with objective evidence of immune CR (iCR) or immune PR (iPR) based on iRECIST guidelines.
Time frame: From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C
Population: No data collection or analysis based on immune-related response criteria (irRC) and iRECIST was performed as iRECIST was implemented during the middle of the study conduct to replace irRC. However, no data was collected and analyzed for iRECIST either. Therefore, no data is available to report for this outcome measure.
Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)
Time frame: Cycle 1 Days 1 and 5; Cycle 2 Days 1 and 5 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts)
Population: The PD population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least one available postbaseline PD measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 104 nanogram per liter (ng/L) | Standard Deviation 61.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 23.0 nanogram per liter (ng/L) | Standard Deviation 10.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 28.0 nanogram per liter (ng/L) | Standard Deviation 24.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 31.2 nanogram per liter (ng/L) | Standard Deviation 19.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 24.7 nanogram per liter (ng/L) | Standard Deviation 10.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 116 nanogram per liter (ng/L) | Standard Deviation 121 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 41.9 nanogram per liter (ng/L) | Standard Deviation 14.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 56.2 nanogram per liter (ng/L) | Standard Deviation 19.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 18.3 nanogram per liter (ng/L) | Standard Deviation 3.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 118 nanogram per liter (ng/L) | Standard Deviation 33 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 95.2 nanogram per liter (ng/L) | Standard Deviation 45.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 106 nanogram per liter (ng/L) | Standard Deviation 76.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 29.1 nanogram per liter (ng/L) | Standard Deviation 10.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 113 nanogram per liter (ng/L) | Standard Deviation 51.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 24.3 nanogram per liter (ng/L) | Standard Deviation 10.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 19.8 nanogram per liter (ng/L) | Standard Deviation 10.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 16.3 nanogram per liter (ng/L) | Standard Deviation 8.03 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 169 nanogram per liter (ng/L) | Standard Deviation 280 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 12.2 nanogram per liter (ng/L) | Standard Deviation 4.56 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 191 nanogram per liter (ng/L) | Standard Deviation 240 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 14.9 nanogram per liter (ng/L) | Standard Deviation 6.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 125 nanogram per liter (ng/L) | Standard Deviation 89.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 223 nanogram per liter (ng/L) | Standard Deviation 229 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 13.8 nanogram per liter (ng/L) | Standard Deviation 7.71 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 31.3 nanogram per liter (ng/L) | Standard Deviation 12.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 2022 nanogram per liter (ng/L) | Standard Deviation 1491 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 173 nanogram per liter (ng/L) | Standard Deviation 199 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 883 nanogram per liter (ng/L) | Standard Deviation 570 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 53.2 nanogram per liter (ng/L) | Standard Deviation 15.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 43.3 nanogram per liter (ng/L) | Standard Deviation 28.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 938 nanogram per liter (ng/L) | Standard Deviation 845 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 1145 nanogram per liter (ng/L) | Standard Deviation 700 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 254 nanogram per liter (ng/L) | Standard Deviation 177 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 802 nanogram per liter (ng/L) | Standard Deviation 797 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 129 nanogram per liter (ng/L) | Standard Deviation 84.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 33.9 nanogram per liter (ng/L) | — |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 351 nanogram per liter (ng/L) | Standard Deviation 448 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 45.1 nanogram per liter (ng/L) | Standard Deviation 28.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 399 nanogram per liter (ng/L) | Standard Deviation 243 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 108 nanogram per liter (ng/L) | Standard Deviation 130 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 171 nanogram per liter (ng/L) | Standard Deviation 78.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 585 nanogram per liter (ng/L) | Standard Deviation 313 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 252 nanogram per liter (ng/L) | Standard Deviation 124 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 148 nanogram per liter (ng/L) | Standard Deviation 14.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 26.4 nanogram per liter (ng/L) | — |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 19.8 nanogram per liter (ng/L) | Standard Deviation 4.81 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 169 nanogram per liter (ng/L) | Standard Deviation 18.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 677 nanogram per liter (ng/L) | Standard Deviation 751 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 1372 nanogram per liter (ng/L) | Standard Deviation 1841 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 15.7 nanogram per liter (ng/L) | — |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 335 nanogram per liter (ng/L) | Standard Deviation 74.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 84.8 nanogram per liter (ng/L) | Standard Deviation 58.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 5240 nanogram per liter (ng/L) | Standard Deviation 5279 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 18.0 nanogram per liter (ng/L) | — |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 1826 nanogram per liter (ng/L) | Standard Deviation 3474 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 519 nanogram per liter (ng/L) | Standard Deviation 475 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 141 nanogram per liter (ng/L) | Standard Deviation 139 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 323 nanogram per liter (ng/L) | Standard Deviation 630 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 43.3 nanogram per liter (ng/L) | Standard Deviation 41.9 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 34.7 nanogram per liter (ng/L) | Standard Deviation 22.7 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 699 nanogram per liter (ng/L) | Standard Deviation 538 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 311 nanogram per liter (ng/L) | Standard Deviation 447 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 341 nanogram per liter (ng/L) | Standard Deviation 252 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 209 nanogram per liter (ng/L) | Standard Deviation 191 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 18.6 nanogram per liter (ng/L) | Standard Deviation 4.19 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 120 nanogram per liter (ng/L) | Standard Deviation 178 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 723 nanogram per liter (ng/L) | Standard Deviation 1077 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 318 nanogram per liter (ng/L) | Standard Deviation 174 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 254 nanogram per liter (ng/L) | Standard Deviation 151 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 50.4 nanogram per liter (ng/L) | Standard Deviation 22.7 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 211 nanogram per liter (ng/L) | Standard Deviation 143 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 162 nanogram per liter (ng/L) | Standard Deviation 183 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 95.7 nanogram per liter (ng/L) | — |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 151 nanogram per liter (ng/L) | — |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 116 nanogram per liter (ng/L) | Standard Deviation 33 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 425 nanogram per liter (ng/L) | Standard Deviation 339 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 15.4 nanogram per liter (ng/L) | — |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 60.3 nanogram per liter (ng/L) | Standard Deviation 19.5 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 23.3 nanogram per liter (ng/L) | Standard Deviation 7.4 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 254 nanogram per liter (ng/L) | Standard Deviation 99.4 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 48.2 nanogram per liter (ng/L) | Standard Deviation 30.3 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 506 nanogram per liter (ng/L) | Standard Deviation 137 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 524 nanogram per liter (ng/L) | Standard Deviation 180 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 73.3 nanogram per liter (ng/L) | Standard Deviation 77.7 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 929 nanogram per liter (ng/L) | Standard Deviation 1962 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 77.0 nanogram per liter (ng/L) | Standard Deviation 106 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 92.6 nanogram per liter (ng/L) | Standard Deviation 86.4 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 70.9 nanogram per liter (ng/L) | Standard Deviation 102 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 667 nanogram per liter (ng/L) | Standard Deviation 1020 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 1269 nanogram per liter (ng/L) | Standard Deviation 1807 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 669 nanogram per liter (ng/L) | Standard Deviation 1075 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 21.1 nanogram per liter (ng/L) | Standard Deviation 6.39 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 47.7 nanogram per liter (ng/L) | Standard Deviation 43.5 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 276 nanogram per liter (ng/L) | Standard Deviation 249 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 290 nanogram per liter (ng/L) | Standard Deviation 296 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 34.5 nanogram per liter (ng/L) | Standard Deviation 15.6 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 513 nanogram per liter (ng/L) | Standard Deviation 585 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 274 nanogram per liter (ng/L) | Standard Deviation 234 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 94.3 nanogram per liter (ng/L) | Standard Deviation 103 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 306 nanogram per liter (ng/L) | Standard Deviation 181 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 527 nanogram per liter (ng/L) | Standard Deviation 538 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 269 nanogram per liter (ng/L) | Standard Deviation 155 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 38.5 nanogram per liter (ng/L) | Standard Deviation 22.2 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 19.7 nanogram per liter (ng/L) | Standard Deviation 3.87 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 70.9 nanogram per liter (ng/L) | Standard Deviation 54.7 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 372 nanogram per liter (ng/L) | Standard Deviation 279 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 18.9 nanogram per liter (ng/L) | Standard Deviation 3.71 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 706 nanogram per liter (ng/L) | Standard Deviation 1757 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 282 nanogram per liter (ng/L) | Standard Deviation 176 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 273 nanogram per liter (ng/L) | Standard Deviation 244 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 64.4 nanogram per liter (ng/L) | Standard Deviation 61.5 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 54.0 nanogram per liter (ng/L) | Standard Deviation 36.1 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 269 nanogram per liter (ng/L) | Standard Deviation 174 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 62.4 nanogram per liter (ng/L) | Standard Deviation 20.7 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 84.4 nanogram per liter (ng/L) | Standard Deviation 87.8 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 200 nanogram per liter (ng/L) | Standard Deviation 101 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 165 nanogram per liter (ng/L) | Standard Deviation 98.6 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 390 nanogram per liter (ng/L) | Standard Deviation 530 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 326 nanogram per liter (ng/L) | Standard Deviation 124 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 1049 nanogram per liter (ng/L) | Standard Deviation 1288 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 718 nanogram per liter (ng/L) | Standard Deviation 649 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 68.3 nanogram per liter (ng/L) | — |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 43.5 nanogram per liter (ng/L) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 1 | 264 nanogram per liter (ng/L) | Standard Deviation 379 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 1 | 31.7 nanogram per liter (ng/L) | Standard Deviation 24.2 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 279 nanogram per liter (ng/L) | Standard Deviation 526 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 1 | 25.8 nanogram per liter (ng/L) | Standard Deviation 1.04 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 101 nanogram per liter (ng/L) | Standard Deviation 71 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 1 | 757 nanogram per liter (ng/L) | Standard Deviation 2165 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 635 nanogram per liter (ng/L) | Standard Deviation 500 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 267 nanogram per liter (ng/L) | Standard Deviation 172 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 2 Day 5 | 41.9 nanogram per liter (ng/L) | Standard Deviation 1.42 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | INF-γ: Cycle 1 Day 5 | 87.7 nanogram per liter (ng/L) | Standard Deviation 42.1 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 2 Day 5 | 123 nanogram per liter (ng/L) | Standard Deviation 19 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6) | IL-6: Cycle 1 Day 5 | 232 nanogram per liter (ng/L) | Standard Deviation 13.8 |
Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells
Time frame: Cycle 1 Day 1 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C)
Population: The pharmacodynamic (PD) population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least one available postbaseline PD measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 197 cells per microliters (cells/mcL) | Standard Deviation 61.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 32.0 cells per microliters (cells/mcL) | Standard Deviation 11.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 247 cells per microliters (cells/mcL) | Standard Deviation 107 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 50.5 cells per microliters (cells/mcL) | Standard Deviation 53.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 204 cells per microliters (cells/mcL) | Standard Deviation 89.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 343 cells per microliters (cells/mcL) | Standard Deviation 20.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 262 cells per microliters (cells/mcL) | Standard Deviation 64.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 56.6 cells per microliters (cells/mcL) | Standard Deviation 22.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 467 cells per microliters (cells/mcL) | Standard Deviation 313 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 685 cells per microliters (cells/mcL) | Standard Deviation 307 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 46.3 cells per microliters (cells/mcL) | Standard Deviation 21.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 466 cells per microliters (cells/mcL) | Standard Deviation 255 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 610 cells per microliters (cells/mcL) | Standard Deviation 570 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 43.3 cells per microliters (cells/mcL) | Standard Deviation 28.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 1053 cells per microliters (cells/mcL) | Standard Deviation 660 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 978 cells per microliters (cells/mcL) | Standard Deviation 400 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 57.4 cells per microliters (cells/mcL) | Standard Deviation 14.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 704 cells per microliters (cells/mcL) | Standard Deviation 559 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 1038 cells per microliters (cells/mcL) | Standard Deviation 1028 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 51.3 cells per microliters (cells/mcL) | Standard Deviation 36 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 703 cells per microliters (cells/mcL) | Standard Deviation 502 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 40.3 cells per microliters (cells/mcL) | Standard Deviation 23.5 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 1392 cells per microliters (cells/mcL) | Standard Deviation 1053 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 1279 cells per microliters (cells/mcL) | Standard Deviation 642 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 773 cells per microliters (cells/mcL) | Standard Deviation 422 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 1470 cells per microliters (cells/mcL) | Standard Deviation 873 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 47.9 cells per microliters (cells/mcL) | Standard Deviation 24 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 262 cells per microliters (cells/mcL) | Standard Deviation 186 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 27.4 cells per microliters (cells/mcL) | Standard Deviation 7.31 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 531 cells per microliters (cells/mcL) | Standard Deviation 296 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 551 cells per microliters (cells/mcL) | Standard Deviation 433 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 804 cells per microliters (cells/mcL) | Standard Deviation 196 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 50.9 cells per microliters (cells/mcL) | Standard Deviation 23.9 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 562 cells per microliters (cells/mcL) | Standard Deviation 373 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 771 cells per microliters (cells/mcL) | Standard Deviation 503 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 42.6 cells per microliters (cells/mcL) | Standard Deviation 28.3 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 37.8 cells per microliters (cells/mcL) | Standard Deviation 24.5 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 533 cells per microliters (cells/mcL) | Standard Deviation 328 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 760 cells per microliters (cells/mcL) | Standard Deviation 458 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 41.6 cells per microliters (cells/mcL) | Standard Deviation 27.7 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 813 cells per microliters (cells/mcL) | Standard Deviation 436 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 688 cells per microliters (cells/mcL) | Standard Deviation 384 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 718 cells per microliters (cells/mcL) | Standard Deviation 567 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 44.3 cells per microliters (cells/mcL) | Standard Deviation 22.5 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 889 cells per microliters (cells/mcL) | Standard Deviation 438 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 51.1 cells per microliters (cells/mcL) | Standard Deviation 9.85 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 924 cells per microliters (cells/mcL) | Standard Deviation 638 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 1081 cells per microliters (cells/mcL) | Standard Deviation 787 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 762 cells per microliters (cells/mcL) | Standard Deviation 538 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 1064 cells per microliters (cells/mcL) | Standard Deviation 445 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 52.6 cells per microliters (cells/mcL) | Standard Deviation 31.3 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Total CD8+ T Cells | 445 cells per microliters (cells/mcL) | Standard Deviation 349 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | Whole Blood FoxP3+ T Cells (Tregs) | 33.1 cells per microliters (cells/mcL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells | NK Cells | 1298 cells per microliters (cells/mcL) | Standard Deviation 334 |
Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Population: The PK population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least 1 measurable serum concentration of nemvaleukin alfa at any scheduled PK time point. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 1.72 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 35.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 1.99 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 10.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 1.90 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 11 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 2.09 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 41.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 5.34 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 2.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 6.72 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 21.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 6.36 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 24.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 6.39 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 12.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 37.4 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 19.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 19.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 32.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 20.5 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 26.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 16.7 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 18.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 47.6 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 177.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 52.9 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 48.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 41.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 178.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 65.3 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 27.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 97.4 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 29 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 113 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 24.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 113 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 33.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 108 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 22.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 112 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 13.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 151 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 36.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 112 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 13 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 95.7 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 37 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 83.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 57.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 104 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 12.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 116 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 33.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 157 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 19.4 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 99.4 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 40.8 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 108 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 86.7 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 103 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 69.5 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 82.1 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 32.3 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 95.1 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 33.8 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 124 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 34.2 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 119 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 27.6 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 99.6 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 18.3 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 15.6 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 18.1 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 18.1 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 15.4 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 19.2 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 21.7 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 14.6 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 24 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 65.6 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 24.4 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 46.5 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 41.6 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 52.9 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 21.9 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 40.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 26.9 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 55.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 37.5 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 61.4 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 22.8 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 55.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 26.9 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 50.3 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 67.9 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 58.1 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 81.2 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 53.1 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 57.9 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 57.5 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 86.5 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 51.7 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 52 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 51.0 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 25.9 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 54.4 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 51.8 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 55.6 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 31.4 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 59.5 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 32.6 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 47.0 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 40.1 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 45.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 48.8 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 47.2 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 47.7 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 49.8 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 52.6 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 99.2 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 20.3 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 131 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 15.8 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 118 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 1.8 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 112 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 15.3 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 101 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 51.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 128 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 30.6 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 133 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 31.7 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 96.6 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 29.7 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 89.3 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 3 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 124 nanograms per milliliters (ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 104 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 1.8 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 94.4 nanograms per milliliters (ng/mL) | Geometric Coefficient of Variation 12.5 |
Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA)
Overall proportion was calculated as: Number of participants (overall positive)/total number of participants in the cohort. Overall positive: Participants with at least 1 treatment-emergent ADA positive sample at any time during the treatment period.
Time frame: From first dose of study drug up to 9 months (for Part A); up to 40.3 months (for Part B); up to 50.5 months (for Part C)
Population: Immunogenicity analysis set included all participants who received at least one dose of active study drug and had at least one post baseline blood sample collected to assess immunogenicity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.00 proportion of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.00 proportion of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.143 proportion of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.125 proportion of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.417 proportion of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.333 proportion of participants |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.600 proportion of participants |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.467 proportion of participants |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.500 proportion of participants |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.00 proportion of participants |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.667 proportion of participants |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.294 proportion of participants |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.250 proportion of participants |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.208 proportion of participants |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.581 proportion of participants |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.667 proportion of participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.200 proportion of participants |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA) | 0.00 proportion of participants |
Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Population: The pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least 1 measurable serum concentration of nemvaleukin alfa at any scheduled PK time point. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 0.909 nanograms per milliliter (ng/mL) | Standard Deviation 0.164 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 16 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 1.44 nanograms per milliliter (ng/mL) | Standard Deviation 0.26 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 16 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 16 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 1.92 nanograms per milliliter (ng/mL) | Standard Deviation 0.296 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 1.61 nanograms per milliliter (ng/mL) | Standard Deviation 0.265 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 0.965 nanograms per milliliter (ng/mL) | Standard Deviation 0.0894 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 0.142 nanograms per milliliter (ng/mL) | Standard Deviation 0.318 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 0.889 nanograms per milliliter (ng/mL) | Standard Deviation 0.174 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 16 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 2.24 nanograms per milliliter (ng/mL) | Standard Deviation 1.06 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 1.36 nanograms per milliliter (ng/mL) | Standard Deviation 0.646 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 1.80 nanograms per milliliter (ng/mL) | Standard Deviation 0.59 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 0.988 nanograms per milliliter (ng/mL) | Standard Deviation 0.0219 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 2.00 nanograms per milliliter (ng/mL) | Standard Deviation 0.238 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 1.55 nanograms per milliliter (ng/mL) | Standard Deviation 0.245 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 1.31 nanograms per milliliter (ng/mL) | Standard Deviation 0.422 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 0.205 nanograms per milliliter (ng/mL) | Standard Deviation 0.41 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 3.43 nanograms per milliliter (ng/mL) | Standard Deviation 0.797 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 4.84 nanograms per milliliter (ng/mL) | Standard Deviation 0.806 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 5.42 nanograms per milliliter (ng/mL) | — |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 6.06 nanograms per milliliter (ng/mL) | Standard Deviation 0.454 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 16 hours | 0.158 nanograms per milliliter (ng/mL) | Standard Deviation 0.316 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 1.17 nanograms per milliliter (ng/mL) | Standard Deviation 0.45 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 4.82 nanograms per milliliter (ng/mL) | Standard Deviation 0.794 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 3.53 nanograms per milliliter (ng/mL) | Standard Deviation 1.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 5.28 nanograms per milliliter (ng/mL) | Standard Deviation 1.07 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 6.00 nanograms per milliliter (ng/mL) | Standard Deviation 1.45 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 2.84 nanograms per milliliter (ng/mL) | Standard Deviation 0.751 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 16 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 16 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 0.453 nanograms per milliliter (ng/mL) | Standard Deviation 0.314 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 1.13 nanograms per milliliter (ng/mL) | Standard Deviation 0.471 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 1.87 nanograms per milliliter (ng/mL) | Standard Deviation 0.71 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 3.83 nanograms per milliliter (ng/mL) | Standard Deviation 1.01 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 5.67 nanograms per milliliter (ng/mL) | Standard Deviation 1.61 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 16 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 6.13 nanograms per milliliter (ng/mL) | Standard Deviation 0.653 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 2.32 nanograms per milliliter (ng/mL) | Standard Deviation 1.45 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 9.26 nanograms per milliliter (ng/mL) | Standard Deviation 5.76 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 1.27 nanograms per milliliter (ng/mL) | Standard Deviation 0.509 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 13.8 nanograms per milliliter (ng/mL) | Standard Deviation 7.79 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 20.1 nanograms per milliliter (ng/mL) | Standard Deviation 8.08 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 0.0868 nanograms per milliliter (ng/mL) | Standard Deviation 0.213 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 0.104 nanograms per milliliter (ng/mL) | Standard Deviation 0.276 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 20.1 nanograms per milliliter (ng/mL) | Standard Deviation 5.32 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 9.09 nanograms per milliliter (ng/mL) | Standard Deviation 3.13 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 20.7 nanograms per milliliter (ng/mL) | Standard Deviation 6.83 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 0.106 nanograms per milliliter (ng/mL) | Standard Deviation 0.28 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 16 hours | 0.522 nanograms per milliliter (ng/mL) | Standard Deviation 0.641 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 17.3 nanograms per milliliter (ng/mL) | Standard Deviation 5.46 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 2.55 nanograms per milliliter (ng/mL) | Standard Deviation 1.27 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 12.6 nanograms per milliliter (ng/mL) | Standard Deviation 4.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 4.18 nanograms per milliliter (ng/mL) | Standard Deviation 1.98 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 16 hours | 0.405 nanograms per milliliter (ng/mL) | Standard Deviation 0.701 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 6.97 nanograms per milliliter (ng/mL) | Standard Deviation 2.25 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 12.3 nanograms per milliliter (ng/mL) | Standard Deviation 2.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 16.6 nanograms per milliliter (ng/mL) | Standard Deviation 3.84 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 24 hours | 0.147 nanograms per milliliter (ng/mL) | Standard Deviation 0.294 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 16 hours | 0.218 nanograms per milliliter (ng/mL) | Standard Deviation 0.378 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 17.2 nanograms per milliliter (ng/mL) | Standard Deviation 3.44 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 16 hours | 0.244 nanograms per milliliter (ng/mL) | Standard Deviation 0.488 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 0.219 nanograms per milliliter (ng/mL) | Standard Deviation 0.342 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 1.16 nanograms per milliliter (ng/mL) | Standard Deviation 1.31 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 4.17 nanograms per milliliter (ng/mL) | Standard Deviation 3.72 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 7.16 nanograms per milliliter (ng/mL) | Standard Deviation 3.53 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 14.7 nanograms per milliliter (ng/mL) | Standard Deviation 3.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 16 hours | 0.625 nanograms per milliliter (ng/mL) | Standard Deviation 0.586 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 14.9 nanograms per milliliter (ng/mL) | Standard Deviation 6.75 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 69.1 nanograms per milliliter (ng/mL) | Standard Deviation 16.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 48.9 nanograms per milliliter (ng/mL) | Standard Deviation 26.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 25.2 nanograms per milliliter (ng/mL) | Standard Deviation 11.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 3.89 nanograms per milliliter (ng/mL) | Standard Deviation 1.58 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 0.914 nanograms per milliliter (ng/mL) | Standard Deviation 0.614 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 71.3 nanograms per milliliter (ng/mL) | Standard Deviation 14 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 16 hours | 1.15 nanograms per milliliter (ng/mL) | Standard Deviation 0.687 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 16 hours | 2.47 nanograms per milliliter (ng/mL) | Standard Deviation 2.14 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 0.619 nanograms per milliliter (ng/mL) | Standard Deviation 0.462 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 44.9 nanograms per milliliter (ng/mL) | Standard Deviation 14.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 9.29 nanograms per milliliter (ng/mL) | Standard Deviation 4.62 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 44.0 nanograms per milliliter (ng/mL) | Standard Deviation 18.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 44.9 nanograms per milliliter (ng/mL) | Standard Deviation 18.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.200 nanograms per milliliter (ng/mL) | Standard Deviation 0.347 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 29.9 nanograms per milliliter (ng/mL) | Standard Deviation 12.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 24 hours | 0.631 nanograms per milliliter (ng/mL) | Standard Deviation 0.63 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 3.25 nanograms per milliliter (ng/mL) | Standard Deviation 1.84 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 1.19 nanograms per milliliter (ng/mL) | Standard Deviation 0.633 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 0.940 nanograms per milliliter (ng/mL) | Standard Deviation 0.561 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 72.2 nanograms per milliliter (ng/mL) | Standard Deviation 13 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 16 hours | 1.50 nanograms per milliliter (ng/mL) | Standard Deviation 1.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 58.8 nanograms per milliliter (ng/mL) | Standard Deviation 25.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 30.1 nanograms per milliliter (ng/mL) | Standard Deviation 18.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 77.9 nanograms per milliliter (ng/mL) | Standard Deviation 15.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 10.0 nanograms per milliliter (ng/mL) | Standard Deviation 4.85 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 24 hours | 0.221 nanograms per milliliter (ng/mL) | Standard Deviation 0.382 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 58.3 nanograms per milliliter (ng/mL) | Standard Deviation 11.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 12.9 nanograms per milliliter (ng/mL) | Standard Deviation 7.19 |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 27.8 nanograms per milliliter (ng/mL) | Standard Deviation 10.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 109 nanograms per milliliter (ng/mL) | Standard Deviation 29.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 16 hours | 4.24 nanograms per milliliter (ng/mL) | Standard Deviation 3.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 2.11 nanograms per milliliter (ng/mL) | Standard Deviation 1.45 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 1.36 nanograms per milliliter (ng/mL) | Standard Deviation 0.589 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 93.9 nanograms per milliliter (ng/mL) | Standard Deviation 22.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 84.8 nanograms per milliliter (ng/mL) | Standard Deviation 23.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 58.4 nanograms per milliliter (ng/mL) | Standard Deviation 19.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 27.1 nanograms per milliliter (ng/mL) | Standard Deviation 10.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 6.93 nanograms per milliliter (ng/mL) | Standard Deviation 3.91 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 16 hours | 1.64 nanograms per milliliter (ng/mL) | Standard Deviation 0.597 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 24 hours | 1.38 nanograms per milliliter (ng/mL) | Standard Deviation 0.697 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.488 nanograms per milliliter (ng/mL) | Standard Deviation 0.376 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 112 nanograms per milliliter (ng/mL) | Standard Deviation 24.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 83.0 nanograms per milliliter (ng/mL) | Standard Deviation 19.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 51.4 nanograms per milliliter (ng/mL) | Standard Deviation 15.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 21.6 nanograms per milliliter (ng/mL) | Standard Deviation 7.61 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 16 hours | 7.27 nanograms per milliliter (ng/mL) | Standard Deviation 4.49 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 2.95 nanograms per milliliter (ng/mL) | Standard Deviation 1.61 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 2.36 nanograms per milliliter (ng/mL) | Standard Deviation 2.29 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 111 nanograms per milliliter (ng/mL) | Standard Deviation 26 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 87.6 nanograms per milliliter (ng/mL) | Standard Deviation 14.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 65.2 nanograms per milliliter (ng/mL) | Standard Deviation 22.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 32.0 nanograms per milliliter (ng/mL) | Standard Deviation 14 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 6.67 nanograms per milliliter (ng/mL) | Standard Deviation 2.74 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 16 hours | 1.65 nanograms per milliliter (ng/mL) | Standard Deviation 0.707 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 24 hours | 1.38 nanograms per milliliter (ng/mL) | Standard Deviation 0.631 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.498 nanograms per milliliter (ng/mL) | Standard Deviation 0.596 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 8.24 nanograms per milliliter (ng/mL) | Standard Deviation 24.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 16.5 nanograms per milliliter (ng/mL) | Standard Deviation 7.44 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 105 nanograms per milliliter (ng/mL) | Standard Deviation 23.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 94.6 nanograms per milliliter (ng/mL) | Standard Deviation 14.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 74.5 nanograms per milliliter (ng/mL) | Standard Deviation 18.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 45.1 nanograms per milliliter (ng/mL) | Standard Deviation 14 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 18.7 nanograms per milliliter (ng/mL) | Standard Deviation 9.48 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 2.24 nanograms per milliliter (ng/mL) | Standard Deviation 1.46 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 57.4 nanograms per milliliter (ng/mL) | Standard Deviation 11.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 24.2 nanograms per milliliter (ng/mL) | Standard Deviation 2.26 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.611 nanograms per milliliter (ng/mL) | Standard Deviation 0.625 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 5.74 nanograms per milliliter (ng/mL) | Standard Deviation 0.0933 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 59.0 nanograms per milliliter (ng/mL) | Standard Deviation 6.87 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 90.5 nanograms per milliliter (ng/mL) | Standard Deviation 16.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 66.4 nanograms per milliliter (ng/mL) | Standard Deviation 6.97 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 1.59 nanograms per milliliter (ng/mL) | Standard Deviation 0.692 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 76.9 nanograms per milliliter (ng/mL) | Standard Deviation 23.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 50.5 nanograms per milliliter (ng/mL) | Standard Deviation 16.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 3.21 nanograms per milliliter (ng/mL) | Standard Deviation 0.253 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 157 nanograms per milliliter (ng/mL) | Standard Deviation 56.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 29.1 nanograms per milliliter (ng/mL) | Standard Deviation 7.92 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 98.4 nanograms per milliliter (ng/mL) | Standard Deviation 10.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 132 nanograms per milliliter (ng/mL) | Standard Deviation 33 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 6.68 nanograms per milliliter (ng/mL) | Standard Deviation 1.85 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 105 nanograms per milliliter (ng/mL) | Standard Deviation 27.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 24.9 nanograms per milliliter (ng/mL) | Standard Deviation 9.77 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 113 nanograms per milliliter (ng/mL) | Standard Deviation 15.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 98.8 nanograms per milliliter (ng/mL) | Standard Deviation 34.7 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 112 nanograms per milliliter (ng/mL) | Standard Deviation 14.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.824 nanograms per milliliter (ng/mL) | Standard Deviation 0.333 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 1.81 nanograms per milliliter (ng/mL) | Standard Deviation 1.3 |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 98.9 nanograms per milliliter (ng/mL) | Standard Deviation 21.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 28.0 nanograms per milliliter (ng/mL) | Standard Deviation 14 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.664 nanograms per milliliter (ng/mL) | Standard Deviation 0.597 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 2.36 nanograms per milliliter (ng/mL) | Standard Deviation 1.11 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 24.9 nanograms per milliliter (ng/mL) | Standard Deviation 13.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 2.51 nanograms per milliliter (ng/mL) | Standard Deviation 1.19 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 121 nanograms per milliliter (ng/mL) | Standard Deviation 40.4 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 62.1 nanograms per milliliter (ng/mL) | Standard Deviation 26.5 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 5.06 nanograms per milliliter (ng/mL) | Standard Deviation 1.68 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 78.4 nanograms per milliliter (ng/mL) | Standard Deviation 39.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 100 nanograms per milliliter (ng/mL) | Standard Deviation 27.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 70.3 nanograms per milliliter (ng/mL) | Standard Deviation 9.27 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 24.3 nanograms per milliliter (ng/mL) | Standard Deviation 11.6 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 49.9 nanograms per milliliter (ng/mL) | Standard Deviation 15.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 1.57 nanograms per milliliter (ng/mL) | Standard Deviation 0.584 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 31.2 nanograms per milliliter (ng/mL) | Standard Deviation 16.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 7.51 nanograms per milliliter (ng/mL) | Standard Deviation 3.23 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 91.2 nanograms per milliliter (ng/mL) | Standard Deviation 40.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 102 nanograms per milliliter (ng/mL) | Standard Deviation 33.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 148 nanograms per milliliter (ng/mL) | Standard Deviation 18.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 1.67 nanograms per milliliter (ng/mL) | Standard Deviation 0.531 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 52.5 nanograms per milliliter (ng/mL) | Standard Deviation 15.8 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 135 nanograms per milliliter (ng/mL) | Standard Deviation 33.9 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 66.2 nanograms per milliliter (ng/mL) | Standard Deviation 15.1 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 5.18 nanograms per milliliter (ng/mL) | Standard Deviation 4.2 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 104 nanograms per milliliter (ng/mL) | Standard Deviation 13 |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 85.9 nanograms per milliliter (ng/mL) | Standard Deviation 26.8 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 78.0 nanograms per milliliter (ng/mL) | Standard Deviation 29.5 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 46.8 nanograms per milliliter (ng/mL) | Standard Deviation 16.5 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 85.1 nanograms per milliliter (ng/mL) | Standard Deviation 28.1 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.578 nanograms per milliliter (ng/mL) | Standard Deviation 0.475 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 7.94 nanograms per milliliter (ng/mL) | Standard Deviation 6.53 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 102 nanograms per milliliter (ng/mL) | Standard Deviation 36.1 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 76.7 nanograms per milliliter (ng/mL) | Standard Deviation 26.5 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 2.03 nanograms per milliliter (ng/mL) | Standard Deviation 1.69 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 93.3 nanograms per milliliter (ng/mL) | Standard Deviation 34.9 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 101 nanograms per milliliter (ng/mL) | Standard Deviation 32.3 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 174 nanograms per milliliter (ng/mL) | Standard Deviation 372 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 26.8 nanograms per milliliter (ng/mL) | Standard Deviation 35.4 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 77.4 nanograms per milliliter (ng/mL) | Standard Deviation 21.5 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 2.11 nanograms per milliliter (ng/mL) | Standard Deviation 13.7 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 27.6 nanograms per milliliter (ng/mL) | Standard Deviation 8.71 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 50.1 nanograms per milliliter (ng/mL) | Standard Deviation 16.2 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.0137 nanograms per milliliter (ng/mL) | Standard Deviation 0.0917 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 1.58 nanograms per milliliter (ng/mL) | Standard Deviation 0.653 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.623 nanograms per milliliter (ng/mL) | Standard Deviation 0.973 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 153 nanograms per milliliter (ng/mL) | Standard Deviation 300 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 31.8 nanograms per milliliter (ng/mL) | Standard Deviation 28.9 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 6.78 nanograms per milliliter (ng/mL) | Standard Deviation 3.25 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 39.4 nanograms per milliliter (ng/mL) | Standard Deviation 43.2 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 55.3 nanograms per milliliter (ng/mL) | Standard Deviation 20.9 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 3.64 nanograms per milliliter (ng/mL) | Standard Deviation 1.9 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 57.8 nanograms per milliliter (ng/mL) | Standard Deviation 20.2 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 94.8 nanograms per milliliter (ng/mL) | Standard Deviation 104 |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 1.51 nanograms per milliliter (ng/mL) | Standard Deviation 0.654 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 24.1 nanograms per milliliter (ng/mL) | Standard Deviation 8.09 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 1.95 nanograms per milliliter (ng/mL) | Standard Deviation 0.854 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 87.9 nanograms per milliliter (ng/mL) | Standard Deviation 23.5 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 83.4 nanograms per milliliter (ng/mL) | Standard Deviation 19.4 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 32.5 nanograms per milliliter (ng/mL) | Standard Deviation 7.83 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 3.53 nanograms per milliliter (ng/mL) | Standard Deviation 1.25 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 30.3 nanograms per milliliter (ng/mL) | Standard Deviation 6.2 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 83.8 nanograms per milliliter (ng/mL) | Standard Deviation 14.8 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 101 nanograms per milliliter (ng/mL) | Standard Deviation 29.2 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 61.0 nanograms per milliliter (ng/mL) | Standard Deviation 14.3 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 1.96 nanograms per milliliter (ng/mL) | Standard Deviation 0.987 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 6.49 nanograms per milliliter (ng/mL) | Standard Deviation 2.96 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 29.1 nanograms per milliliter (ng/mL) | Standard Deviation 10.4 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.120 nanograms per milliliter (ng/mL) | Standard Deviation 0.41 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 117 nanograms per milliliter (ng/mL) | Standard Deviation 19.9 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.396 nanograms per milliliter (ng/mL) | Standard Deviation 0.45 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 66.4 nanograms per milliliter (ng/mL) | Standard Deviation 15.9 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 106 nanograms per milliliter (ng/mL) | Standard Deviation 30.3 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 57.1 nanograms per milliliter (ng/mL) | Standard Deviation 14.9 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.0329 nanograms per milliliter (ng/mL) | Standard Deviation 0.171 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 131 nanograms per milliliter (ng/mL) | Standard Deviation 51.3 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 1.72 nanograms per milliliter (ng/mL) | Standard Deviation 0.599 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 101 nanograms per milliliter (ng/mL) | Standard Deviation 18.6 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.538 nanograms per milliliter (ng/mL) | Standard Deviation 0.383 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 6.33 nanograms per milliliter (ng/mL) | Standard Deviation 2.04 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 97.6 nanograms per milliliter (ng/mL) | Standard Deviation 21.7 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 62.0 nanograms per milliliter (ng/mL) | Standard Deviation 17.8 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 123 nanograms per milliliter (ng/mL) | Standard Deviation 31.7 |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 0.209 nanograms per milliliter (ng/mL) | Standard Deviation 0.361 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 2.51 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 15.8 nanograms per milliliter (ng/mL) | Standard Deviation 2.82 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 4.49 nanograms per milliliter (ng/mL) | Standard Deviation 1.26 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 1.86 nanograms per milliliter (ng/mL) | Standard Deviation 0.257 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 18.9 nanograms per milliliter (ng/mL) | Standard Deviation 2.5 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 17.4 nanograms per milliliter (ng/mL) | Standard Deviation 5.33 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 13.4 nanograms per milliliter (ng/mL) | Standard Deviation 3.07 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 6.18 nanograms per milliliter (ng/mL) | Standard Deviation 0.687 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 1.47 nanograms per milliliter (ng/mL) | Standard Deviation 0.445 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 7.00 nanograms per milliliter (ng/mL) | Standard Deviation 0.412 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 10.3 nanograms per milliliter (ng/mL) | Standard Deviation 4.44 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 19.5 nanograms per milliliter (ng/mL) | Standard Deviation 3.9 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 13.7 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 16.8 nanograms per milliliter (ng/mL) | Standard Deviation 5.53 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 6.40 nanograms per milliliter (ng/mL) | Standard Deviation 2.13 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 0.498 nanograms per milliliter (ng/mL) | Standard Deviation 0.704 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 13.1 nanograms per milliliter (ng/mL) | Standard Deviation 0.626 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 18.6 nanograms per milliliter (ng/mL) | Standard Deviation 3.94 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 8.74 nanograms per milliliter (ng/mL) | Standard Deviation 1.5 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 14.0 nanograms per milliliter (ng/mL) | Standard Deviation 2.74 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 0.180 nanograms per milliliter (ng/mL) | Standard Deviation 0.312 |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 11.3 nanograms per milliliter (ng/mL) | Standard Deviation 1.39 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 28.2 nanograms per milliliter (ng/mL) | Standard Deviation 64.5 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 67.1 nanograms per milliliter (ng/mL) | Standard Deviation 14.9 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 50.0 nanograms per milliliter (ng/mL) | Standard Deviation 22.3 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 8.11 nanograms per milliliter (ng/mL) | Standard Deviation 2.77 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 38.7 nanograms per milliliter (ng/mL) | Standard Deviation 17.4 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 21.9 nanograms per milliliter (ng/mL) | Standard Deviation 7.94 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 9.63 nanograms per milliliter (ng/mL) | Standard Deviation 4.37 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 21.3 nanograms per milliliter (ng/mL) | Standard Deviation 4.81 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 16 hours | 0.00 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 1.46 nanograms per milliliter (ng/mL) | Standard Deviation 0.803 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 0.416 nanograms per milliliter (ng/mL) | Standard Deviation 0.538 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 49.5 nanograms per milliliter (ng/mL) | Standard Deviation 19.7 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 33.8 nanograms per milliliter (ng/mL) | Standard Deviation 7.91 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 45.6 nanograms per milliliter (ng/mL) | Standard Deviation 22.3 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 31.8 nanograms per milliliter (ng/mL) | Standard Deviation 17 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 13.1 nanograms per milliliter (ng/mL) | Standard Deviation 11.7 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 44.3 nanograms per milliliter (ng/mL) | Standard Deviation 9.53 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 19.5 nanograms per milliliter (ng/mL) | Standard Deviation 4.9 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 3.39 nanograms per milliliter (ng/mL) | Standard Deviation 3.39 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 0.756 nanograms per milliliter (ng/mL) | Standard Deviation 0.786 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 8.66 nanograms per milliliter (ng/mL) | Standard Deviation 4.83 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 56.3 nanograms per milliliter (ng/mL) | Standard Deviation 9.99 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 0.737 nanograms per milliliter (ng/mL) | Standard Deviation 0.518 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 48.2 nanograms per milliliter (ng/mL) | Standard Deviation 13.7 |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 35.6 nanograms per milliliter (ng/mL) | Standard Deviation 8.32 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 42.5 nanograms per milliliter (ng/mL) | Standard Deviation 9.2 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 1.06 nanograms per milliliter (ng/mL) | Standard Deviation 1.06 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 10.2 nanograms per milliliter (ng/mL) | Standard Deviation 2.88 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 3.33 nanograms per milliliter (ng/mL) | Standard Deviation 1.87 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 1.10 nanograms per milliliter (ng/mL) | Standard Deviation 0.965 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 69.8 nanograms per milliliter (ng/mL) | Standard Deviation 124 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 61.7 nanograms per milliliter (ng/mL) | Standard Deviation 13.4 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 2.14 nanograms per milliliter (ng/mL) | Standard Deviation 6.54 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 57.8 nanograms per milliliter (ng/mL) | Standard Deviation 15.4 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 28.6 nanograms per milliliter (ng/mL) | Standard Deviation 9.1 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 47.2 nanograms per milliliter (ng/mL) | Standard Deviation 12.7 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 3.41 nanograms per milliliter (ng/mL) | Standard Deviation 1.66 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 1.64 nanograms per milliliter (ng/mL) | Standard Deviation 1.44 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.0170 nanograms per milliliter (ng/mL) | Standard Deviation 0.0945 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 13.2 nanograms per milliliter (ng/mL) | Standard Deviation 5.51 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 12.0 nanograms per milliliter (ng/mL) | Standard Deviation 4.47 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 38.8 nanograms per milliliter (ng/mL) | Standard Deviation 9.33 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 25.6 nanograms per milliliter (ng/mL) | Standard Deviation 5.22 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 7.91 nanograms per milliliter (ng/mL) | Standard Deviation 3.47 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 58.3 nanograms per milliliter (ng/mL) | Standard Deviation 25.3 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 30.6 nanograms per milliliter (ng/mL) | Standard Deviation 9.57 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 64.2 nanograms per milliliter (ng/mL) | Standard Deviation 60.1 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 51.5 nanograms per milliliter (ng/mL) | Standard Deviation 10 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 25.1 nanograms per milliliter (ng/mL) | Standard Deviation 12.7 |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 56.3 nanograms per milliliter (ng/mL) | Standard Deviation 11.2 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 54.2 nanograms per milliliter (ng/mL) | Standard Deviation 14.2 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 42.7 nanograms per milliliter (ng/mL) | Standard Deviation 12.9 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.210 nanograms per milliliter (ng/mL) | Standard Deviation 0.419 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 10.8 nanograms per milliliter (ng/mL) | Standard Deviation 4.41 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 4.85 nanograms per milliliter (ng/mL) | Standard Deviation 3.63 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 8.85 nanograms per milliliter (ng/mL) | Standard Deviation 3.92 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 0.922 nanograms per milliliter (ng/mL) | Standard Deviation 0.67 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 24.0 nanograms per milliliter (ng/mL) | Standard Deviation 7.15 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 47.3 nanograms per milliliter (ng/mL) | Standard Deviation 12.2 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 79.6 nanograms per milliliter (ng/mL) | Standard Deviation 93.1 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 71.5 nanograms per milliliter (ng/mL) | Standard Deviation 51.7 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 1.64 nanograms per milliliter (ng/mL) | Standard Deviation 1.42 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 14.8 nanograms per milliliter (ng/mL) | Standard Deviation 6 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 3.99 nanograms per milliliter (ng/mL) | Standard Deviation 1.69 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 31.8 nanograms per milliliter (ng/mL) | Standard Deviation 9.39 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 43.6 nanograms per milliliter (ng/mL) | Standard Deviation 11.5 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 2.16 nanograms per milliliter (ng/mL) | Standard Deviation 3.95 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 1.16 nanograms per milliliter (ng/mL) | Standard Deviation 0.777 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 29.9 nanograms per milliliter (ng/mL) | Standard Deviation 9.94 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 61.6 nanograms per milliliter (ng/mL) | Standard Deviation 25.5 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 63.6 nanograms per milliliter (ng/mL) | Standard Deviation 41.8 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 17.2 nanograms per milliliter (ng/mL) | Standard Deviation 18.5 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 38.3 nanograms per milliliter (ng/mL) | Standard Deviation 11.1 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 27.6 nanograms per milliliter (ng/mL) | Standard Deviation 7.91 |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 58.8 nanograms per milliliter (ng/mL) | Standard Deviation 38.5 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 52.7 nanograms per milliliter (ng/mL) | Standard Deviation 14.4 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 13.3 nanograms per milliliter (ng/mL) | Standard Deviation 5.22 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 47.8 nanograms per milliliter (ng/mL) | Standard Deviation 13 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 1.29 nanograms per milliliter (ng/mL) | Standard Deviation 0.749 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 62.5 nanograms per milliliter (ng/mL) | Standard Deviation 20.2 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 27.4 nanograms per milliliter (ng/mL) | Standard Deviation 9.8 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 61.1 nanograms per milliliter (ng/mL) | Standard Deviation 30.1 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 1.15 nanograms per milliliter (ng/mL) | Standard Deviation 1.4 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 16 hours | 4.95 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 28.5 nanograms per milliliter (ng/mL) | Standard Deviation 9.68 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 13.0 nanograms per milliliter (ng/mL) | Standard Deviation 7.01 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 3.94 nanograms per milliliter (ng/mL) | Standard Deviation 1.97 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 10.8 nanograms per milliliter (ng/mL) | Standard Deviation 4.29 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 3.26 nanograms per milliliter (ng/mL) | Standard Deviation 1.32 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 16 hours | 1.97 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 41.9 nanograms per milliliter (ng/mL) | Standard Deviation 11.7 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 1.01 nanograms per milliliter (ng/mL) | Standard Deviation 1.71 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 21.4 nanograms per milliliter (ng/mL) | Standard Deviation 8.75 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 42.3 nanograms per milliliter (ng/mL) | Standard Deviation 15.5 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.103 nanograms per milliliter (ng/mL) | Standard Deviation 0.273 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 26.4 nanograms per milliliter (ng/mL) | Standard Deviation 8.67 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 2.10 nanograms per milliliter (ng/mL) | Standard Deviation 9.24 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 42.6 nanograms per milliliter (ng/mL) | Standard Deviation 13.8 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 7.40 nanograms per milliliter (ng/mL) | Standard Deviation 3.67 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 37.1 nanograms per milliliter (ng/mL) | Standard Deviation 10.5 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 0.933 nanograms per milliliter (ng/mL) | Standard Deviation 0.529 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 57.5 nanograms per milliliter (ng/mL) | Standard Deviation 17.9 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 55.7 nanograms per milliliter (ng/mL) | Standard Deviation 22.7 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 11.8 nanograms per milliliter (ng/mL) | Standard Deviation 11.9 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 35.6 nanograms per milliliter (ng/mL) | Standard Deviation 30.6 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 2.94 nanograms per milliliter (ng/mL) | Standard Deviation 6.88 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 34.0 nanograms per milliliter (ng/mL) | Standard Deviation 18.8 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 43.0 nanograms per milliliter (ng/mL) | Standard Deviation 27.4 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 25.2 nanograms per milliliter (ng/mL) | Standard Deviation 32.6 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 12.8 nanograms per milliliter (ng/mL) | Standard Deviation 18.3 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 17.7 nanograms per milliliter (ng/mL) | Standard Deviation 16.2 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 22.5 nanograms per milliliter (ng/mL) | Standard Deviation 13.6 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 56.7 nanograms per milliliter (ng/mL) | Standard Deviation 31.1 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 51.1 nanograms per milliliter (ng/mL) | Standard Deviation 28 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 36.7 nanograms per milliliter (ng/mL) | Standard Deviation 27.9 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 49.9 nanograms per milliliter (ng/mL) | Standard Deviation 37 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 4.17 nanograms per milliliter (ng/mL) | Standard Deviation 8.72 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 3.90 nanograms per milliliter (ng/mL) | Standard Deviation 9.89 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 4.96 nanograms per milliliter (ng/mL) | Standard Deviation 11.7 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 24.1 nanograms per milliliter (ng/mL) | Standard Deviation 19.1 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 7.80 nanograms per milliliter (ng/mL) | Standard Deviation 12.3 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 45.0 nanograms per milliliter (ng/mL) | Standard Deviation 28.2 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 51.8 nanograms per milliliter (ng/mL) | Standard Deviation 29.6 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 48.1 nanograms per milliliter (ng/mL) | Standard Deviation 28.2 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 16 hours | 1.69 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.0151 nanograms per milliliter (ng/mL) | Standard Deviation 0.0988 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 12.2 nanograms per milliliter (ng/mL) | Standard Deviation 19.7 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 39.6 nanograms per milliliter (ng/mL) | Standard Deviation 38.3 |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 48.9 nanograms per milliliter (ng/mL) | Standard Deviation 19.8 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 105 nanograms per milliliter (ng/mL) | Standard Deviation 14.3 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 120 nanograms per milliliter (ng/mL) | Standard Deviation 22 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 27.7 nanograms per milliliter (ng/mL) | Standard Deviation 6.94 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 2.03 nanograms per milliliter (ng/mL) | Standard Deviation 0.979 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 28.4 nanograms per milliliter (ng/mL) | Standard Deviation 1.42 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 94.9 nanograms per milliliter (ng/mL) | Standard Deviation 19.7 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 92.6 nanograms per milliliter (ng/mL) | Standard Deviation 16.1 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 100 nanograms per milliliter (ng/mL) | Standard Deviation 20 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 29.8 nanograms per milliliter (ng/mL) | Standard Deviation 2.81 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 113 nanograms per milliliter (ng/mL) | Standard Deviation 16.8 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 54.9 nanograms per milliliter (ng/mL) | Standard Deviation 6.38 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 65.1 nanograms per milliliter (ng/mL) | Standard Deviation 0.651 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 120 nanograms per milliliter (ng/mL) | Standard Deviation 6.24 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 117 nanograms per milliliter (ng/mL) | Standard Deviation 17.2 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 24.3 nanograms per milliliter (ng/mL) | Standard Deviation 3.79 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 118 nanograms per milliliter (ng/mL) | Standard Deviation 2.15 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 57.6 nanograms per milliliter (ng/mL) | Standard Deviation 10.5 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 86.3 nanograms per milliliter (ng/mL) | Standard Deviation 15 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 3.16 nanograms per milliliter (ng/mL) | Standard Deviation 1.58 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 1.45 nanograms per milliliter (ng/mL) | Standard Deviation 0.417 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 4.98 nanograms per milliliter (ng/mL) | Standard Deviation 1.92 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 20.2 nanograms per milliliter (ng/mL) | Standard Deviation 18.7 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 4.49 nanograms per milliliter (ng/mL) | Standard Deviation 2.06 |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 63.8 nanograms per milliliter (ng/mL) | Standard Deviation 12.3 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 24.0 nanograms per milliliter (ng/mL) | Standard Deviation 11.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 90.9 nanograms per milliliter (ng/mL) | Standard Deviation 24.6 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 102 nanograms per milliliter (ng/mL) | Standard Deviation 29.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 13.8 nanograms per milliliter (ng/mL) | Standard Deviation 43 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 71.1 nanograms per milliliter (ng/mL) | Standard Deviation 23.8 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 100 nanograms per milliliter (ng/mL) | Standard Deviation 28.8 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 32.4 nanograms per milliliter (ng/mL) | Standard Deviation 13.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 30.2 nanograms per milliliter (ng/mL) | Standard Deviation 8.92 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 8.60 nanograms per milliliter (ng/mL) | Standard Deviation 5.71 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 59.9 nanograms per milliliter (ng/mL) | Standard Deviation 19.7 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 2.17 nanograms per milliliter (ng/mL) | Standard Deviation 1.46 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 84.4 nanograms per milliliter (ng/mL) | Standard Deviation 24.6 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 59.7 nanograms per milliliter (ng/mL) | Standard Deviation 15.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.610 nanograms per milliliter (ng/mL) | Standard Deviation 0.00778 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 93.5 nanograms per milliliter (ng/mL) | Standard Deviation 30.7 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.372 nanograms per milliliter (ng/mL) | Standard Deviation 1.36 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 2.67 nanograms per milliliter (ng/mL) | Standard Deviation 2.06 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 2.98 nanograms per milliliter (ng/mL) | Standard Deviation 1.51 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 54.7 nanograms per milliliter (ng/mL) | Standard Deviation 16.7 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 121 nanograms per milliliter (ng/mL) | Standard Deviation 32.2 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0.5 hour | 137 nanograms per milliliter (ng/mL) | Standard Deviation 47.3 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 114 nanograms per milliliter (ng/mL) | Standard Deviation 29.2 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 30.8 nanograms per milliliter (ng/mL) | Standard Deviation 12.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 131 nanograms per milliliter (ng/mL) | Standard Deviation 52.7 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 240 hours | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 9.78 nanograms per milliliter (ng/mL) | Standard Deviation 5.22 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 1.17 nanograms per milliliter (ng/mL) | Standard Deviation 0.409 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 111 nanograms per milliliter (ng/mL) | Standard Deviation 42.4 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 4 hours | 58.0 nanograms per milliliter (ng/mL) | Standard Deviation 8.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 24 hours | 3.19 nanograms per milliliter (ng/mL) | Standard Deviation 1.1 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 8 hours | 26.4 nanograms per milliliter (ng/mL) | Standard Deviation 6.55 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 8 hours | 8.47 nanograms per milliliter (ng/mL) | Standard Deviation 3.87 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0.5 hour | 104 nanograms per milliliter (ng/mL) | Standard Deviation 1.86 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 1 hour | 86.3 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 1 hour | 89.7 nanograms per milliliter (ng/mL) | Standard Deviation 4.66 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 0 hour | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 2 hours | 70.7 nanograms per milliliter (ng/mL) | Standard Deviation 5.51 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 1 hour | 89.8 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 72 hours | 0.741 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 72 hours | 0.989 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 4 hours | 48.9 nanograms per milliliter (ng/mL) | Standard Deviation 12.6 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 2 hours | 67.3 nanograms per milliliter (ng/mL) | Standard Deviation 4.5 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0 hour | 1.86 nanograms per milliliter (ng/mL) | Standard Deviation 0.354 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 8 hours | 7.22 nanograms per milliliter (ng/mL) | Standard Deviation 0.698 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 4 hours | 33.4 nanograms per milliliter (ng/mL) | Standard Deviation 7.99 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 8 hours | 18.7 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 2 hours | 66.5 nanograms per milliliter (ng/mL) | Standard Deviation 4.01 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 0.5 hour | 103 nanograms per milliliter (ng/mL) | — |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 24 hours | 3.45 nanograms per milliliter (ng/mL) | Standard Deviation 1.59 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 5: 0 hour | 1.92 nanograms per milliliter (ng/mL) | Standard Deviation 0.336 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 1 Day 1: 0.5 hour | 89.3 nanograms per milliliter (ng/mL) | Standard Deviation 2.71 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 1 hour | 120 nanograms per milliliter (ng/mL) | Standard Deviation 5.86 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 5: 4 hours | 34.7 nanograms per milliliter (ng/mL) | Standard Deviation 8.12 |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa | Cycle 2 Day 1: 2 hours | 89.7 nanograms per milliliter (ng/mL) | Standard Deviation 5.33 |
Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa
Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.
Time frame: Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose
Population: The PK population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least 1 measurable serum concentration of nemvaleukin alfa at any scheduled PK time point. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.60 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.70 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.63 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.67 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.57 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.60 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.63 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.73 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.55 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.55 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.53 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.54 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.55 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.55 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.57 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.68 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.60 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.58 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.58 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.57 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.58 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.53 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.57 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.53 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.51 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.52 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.52 hours |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.53 hours |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.52 hours |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.50 hours |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.50 hours |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.51 hours |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.50 hours |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.50 hours |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.50 hours |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.50 hours |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.58 hours |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.71 hours |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.72 hours |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.75 hours |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.73 hours |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.68 hours |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.68 hours |
| Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.73 hours |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.55 hours |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.55 hours |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.55 hours |
| Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.57 hours |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.55 hours |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.53 hours |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.55 hours |
| Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.53 hours |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.52 hours |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.53 hours |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.50 hours |
| Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.55 hours |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.50 hours |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.50 hours |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.50 hours |
| Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.50 hours |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.56 hours |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.55 hours |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.50 hours |
| Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.58 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.52 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.52 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.53 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 0.52 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 5 | 0.83 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 1 | 1.00 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 2 Day 5 | 0.77 hours |
| Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mg | Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa | Cycle 1 Day 1 | 0.78 hours |
Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1
Duration of response was defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)
Population: The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan. Here, overall number of participants analyzed signified participants who had CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | 18.43 weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | 28.86 weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | 35.14 weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | NA weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | 63.14 weeks |
| Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | NA weeks |
| Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | NA weeks |
| Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | 39.07 weeks |
| Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg | Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1 | 27.86 weeks |
Parts B, and C: Immune DOR (iDOR) Based on iRECIST
iDOR was defined as the time from the first documentation of response (iCR or iPR) to the first documentation of objective tumor progression (immune confirmed progressive disease \[iCPD\]) or death due to any cause based on iRECIST.
Time frame: From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C
Population: No data collection or analysis based on irRC and iRECIST was performed as iRECIST was implemented during the middle of the study conduct to replace irRC. However, no data was collected and analyzed for iRECIST either. Therefore, no data is available to report for this outcome measure.