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A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02799095
Enrollment
243
Registered
2016-06-14
Start date
2016-09-14
Completion date
2023-08-02
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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

DRUGALKS 4230 + pembrolizumab

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

Mural Oncology, Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
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 GradingFrom 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) 1.1From first dose of study drug up to 40.3 months for Part B and up to 50.5 months for Part CORR 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

MeasureTime frameDescription
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 CiORR 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.1.1From 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 CDisease 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 v1.1From 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 CiDCR 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 v1.1From 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 iRECISTFrom first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part CiDOR 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 AlfaCycle 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-doseCycle 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 iRECISTFrom first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part CiDRR 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.1.1From 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 CiPFS 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) CellsCycle 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.1.1From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part CDRR 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 AlfaCycle 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-doseCycle 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 AlfaCycle 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-doseCycle 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 AlfaCycle 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-doseCycle 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

ArmCount
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
Total286

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014FG015FG016
Part AAdverse Event10141000000000000
Part AClinical Progression10215000000000000
Part ADeath00000030000000000
Part ALost to Follow-up01000010000000000
Part AProgressive Disease33322000000000000
Part AProtocol Deviation00100000000000000
Part ARolled Over to Part C, Cohort 400001220000000000
Part AWithdrawal by Subject00013110000000000
Part BDeath00000007700000000
Part BProgressive Disease00000001000000000
Part BRolled Over to Part C, Cohort 40000000261200000000
Part BWithdrawal by Subject000000010700000000
Part CAdverse Event00000000003101000
Part CClinical Progression00000000013001000
Part CDeath00000000007568181
Part CLost to Follow-up00000000001113000
Part COther00000000000220000
Part CPhysician Decision00000000001000000
Part CProgressive Disease000000000213201000
Part CWithdrawal by Subject0000000000131513210121

Baseline characteristics

CharacteristicPart A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgPart A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgPart A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgPart A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgPart A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgPart A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgPart B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgPart B, Dose Expansion, RCC: Nemvaleukin 6 Alfa mcg/kgPart C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgPart C, Combination Therapy, Cohort 1 + Safety Run-in: Nemvaleukin Alfa 3mcg/kg +Pembrolizumab 200mgPart C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgPart A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgPart C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgPart C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgPart C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgPart C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgPart C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgTotal
Age, Customized
Part A
18 to 64 years
3 Participants5 Participants4 Participants4 Participants3 Participants4 Participants0 Participants0 Participants0 Participants0 Participants0 Participants5 Participants0 Participants0 Participants0 Participants0 Participants0 Participants28 Participants
Age, Customized
Part A
65 to 84 years
1 Participants2 Participants4 Participants8 Participants0 Participants3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants18 Participants
Age, Customized
Part A
> 84 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
Part B
18 to 64 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants20 Participants10 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants30 Participants
Age, Customized
Part B
65 to 84 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants27 Participants17 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants44 Participants
Age, Customized
Part B
> 84 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
Part C
18 to 64 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants30 Participants20 Participants0 Participants15 Participants18 Participants1 Participants11 Participants1 Participants96 Participants
Age, Customized
Part C
65 to 84 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants3 Participants12 Participants6 Participants0 Participants11 Participants25 Participants2 Participants9 Participants1 Participants69 Participants
Age, Customized
Part C
> 84 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Part A
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Part A
Not Hispanic or Latino
4 Participants7 Participants8 Participants12 Participants3 Participants6 Participants4 Participants44 Participants
Ethnicity (NIH/OMB)
Part A
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Part B
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Part B
Not Hispanic or Latino
47 Participants26 Participants73 Participants
Ethnicity (NIH/OMB)
Part B
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Part C
Hispanic or Latino
0 Participants1 Participants1 Participants2 Participants1 Participants0 Participants1 Participants0 Participants6 Participants
Ethnicity (NIH/OMB)
Part C
Not Hispanic or Latino
3 Participants40 Participants25 Participants24 Participants42 Participants3 Participants20 Participants2 Participants159 Participants
Ethnicity (NIH/OMB)
Part C
Unknown or Not Reported
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Part A
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part A
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part A
Black or African American
0 Participants1 Participants0 Participants2 Participants1 Participants0 Participants0 Participants4 Participants
Race (NIH/OMB)
Part A
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part A
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part A
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Part A
White
4 Participants6 Participants8 Participants10 Participants2 Participants6 Participants5 Participants41 Participants
Race (NIH/OMB)
Part B
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part B
Asian
5 Participants1 Participants6 Participants
Race (NIH/OMB)
Part B
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Part B
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part B
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part B
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part B
White
42 Participants25 Participants67 Participants
Race (NIH/OMB)
Part C
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part C
Asian
0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants1 Participants0 Participants3 Participants
Race (NIH/OMB)
Part C
Black or African American
0 Participants7 Participants3 Participants3 Participants1 Participants0 Participants1 Participants0 Participants15 Participants
Race (NIH/OMB)
Part C
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part C
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Part C
Unknown or Not Reported
0 Participants1 Participants2 Participants1 Participants1 Participants0 Participants1 Participants0 Participants6 Participants
Race (NIH/OMB)
Part C
White
3 Participants34 Participants20 Participants22 Participants40 Participants3 Participants18 Participants2 Participants142 Participants
Sex: Female, Male
Part A
Female
1 Participants0 Participants4 Participants7 Participants2 Participants4 Participants1 Participants19 Participants
Sex: Female, Male
Part A
Male
3 Participants7 Participants4 Participants5 Participants1 Participants3 Participants4 Participants27 Participants
Sex: Female, Male
Part B
Female
22 Participants3 Participants25 Participants
Sex: Female, Male
Part B
Male
25 Participants24 Participants49 Participants
Sex: Female, Male
Part C
Female
1 Participants28 Participants12 Participants13 Participants18 Participants1 Participants7 Participants1 Participants81 Participants
Sex: Female, Male
Part C
Male
2 Participants14 Participants14 Participants13 Participants25 Participants2 Participants14 Participants1 Participants85 Participants

Adverse events

Event typeEG000
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 / 50 / 40 / 70 / 81 / 120 / 33 / 77 / 477 / 270 / 37 / 427 / 268 / 268 / 431 / 38 / 211 / 2
other
Total, other adverse events
5 / 54 / 47 / 78 / 812 / 123 / 37 / 746 / 4727 / 273 / 342 / 4226 / 2625 / 2638 / 433 / 321 / 212 / 2
serious
Total, serious adverse events
2 / 50 / 42 / 73 / 85 / 120 / 35 / 711 / 4712 / 270 / 319 / 4210 / 2611 / 2614 / 432 / 312 / 212 / 2

Outcome results

Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgPart 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/kgPart 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/kgPart 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/kgPart 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/kgPart 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/kgPart 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/kgPart A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE)1 Participants
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs3 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs2 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs1 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs3 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs3 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs4 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs6 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs2 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs3 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs8 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs1 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs0 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs1 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs2 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs1 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs3 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs1 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs2 Participants
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs28 Participants
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs6 Participants
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs12 Participants
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs1 Participants
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs5 Participants
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs16 Participants
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs5 Participants
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs0 Participants
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs3 Participants
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs0 Participants
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs4 Participants
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs3 Participants
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs19 Participants
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs16 Participants
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs5 Participants
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs7 Participants
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs14 Participants
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs6 Participants
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs5 Participants
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs15 Participants
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs21 Participants
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs4 Participants
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs1 Participants
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs13 Participants
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs1 Participants
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs1 Participants
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs1 Participants
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs4 Participants
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs1 Participants
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs16 Participants
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 3 TEAEs1 Participants
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 5 TEAEs0 Participants
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 4 TEAEs1 Participants
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Number of Participants With TEAEs by Severity GradingParticipants With Grade 1 and 2 TEAEs0 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)5 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)4 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)7 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)8 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)12 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)3 Participants
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)7 Participants
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)46 Participants
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts 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/kgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)2 Participants
Primary

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.

ArmMeasureValue (NUMBER)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.18.7 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.113.6 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.10.0 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.113.9 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.10.0 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.128.6 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.17.7 percentage of participants
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.166.7 percentage of participants
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.111.1 percentage of participants
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.150.0 percentage of participants
Secondary

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.

Secondary

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.

Secondary

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.

Secondary

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.

ArmMeasureValue (MEDIAN)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgPart B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.116.14 weeks
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgPart B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.112.43 weeks
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgPart B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1NA weeks
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgPart B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.118.64 weeks
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgPart B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.135.57 weeks
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 12.47 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 32.4
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 52.52 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 17.3
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 52.61 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 16.6
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 12.96 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 53.1
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 115.3 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 45.4
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 117.0 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 35.6
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 514.4 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 23.6
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 511.5 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 18.4
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 548.2 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 55.9
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 169.2 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 50.3
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 166.5 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 36.5
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 540.8 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 21.2
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1195 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 252.1
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5167 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 51.5
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5106 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 205.5
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1274 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 39
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5361 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 50.4
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1478 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 30.7
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1557 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 28.7
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5379 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 46
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5323 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 84.1
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1616 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 42.3
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1512 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 35.6
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5439 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 3.5
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5312 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 131
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5346 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 47.8
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1573 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 36.8
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1719 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 39.7
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1608 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 30.1
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1517 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 44.5
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5287 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 60.9
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5292 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 61.4
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5312 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 40.6
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1723 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 23.2
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1594 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 25.9
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5329 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 45.3
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 156.1 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 12.9
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 184.1 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 39.5
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 556.7 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 18.8
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 552.0 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1248 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5121 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1195 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5120 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5143 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1286 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1235 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5135 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1243 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5158 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1296 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5134 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5128 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5130 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1212 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1276 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5139 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1222 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1224 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5153 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5275 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1698 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5343 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1625 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5368 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1562 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1715 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5346 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 1543 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 1590 hour*nanogram per milliliter (h*ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 1 Day 5393 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 mgParts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin AlfaCycle 2 Day 5413 hour*nanogram per milliliter (h*ng/mL)Geometric Coefficient of Variation 57.6
Secondary

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.

ArmMeasureValue (NUMBER)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.10.0 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.125.0 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.120.0 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.160.0 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.133.3 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.133.3 percentage of participants
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.125.0 percentage of participants
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.147.8 percentage of participants
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.150.0 percentage of participants
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.10.0 percentage of participants
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.130.6 percentage of participants
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.122.7 percentage of participants
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.147.6 percentage of participants
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.146.2 percentage of participants
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.166.7 percentage of participants
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.150.0 percentage of participants
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1100 percentage of participants
Secondary

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.

Secondary

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.

Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1104 nanogram per liter (ng/L)Standard Deviation 61.8
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 123.0 nanogram per liter (ng/L)Standard Deviation 10.3
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 128.0 nanogram per liter (ng/L)Standard Deviation 24.1
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 531.2 nanogram per liter (ng/L)Standard Deviation 19.2
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 524.7 nanogram per liter (ng/L)Standard Deviation 10.8
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5116 nanogram per liter (ng/L)Standard Deviation 121
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 141.9 nanogram per liter (ng/L)Standard Deviation 14.7
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 556.2 nanogram per liter (ng/L)Standard Deviation 19.1
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 118.3 nanogram per liter (ng/L)Standard Deviation 3.7
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1118 nanogram per liter (ng/L)Standard Deviation 33
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 595.2 nanogram per liter (ng/L)Standard Deviation 45.3
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1106 nanogram per liter (ng/L)Standard Deviation 76.4
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 529.1 nanogram per liter (ng/L)Standard Deviation 10.7
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5113 nanogram per liter (ng/L)Standard Deviation 51.9
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 524.3 nanogram per liter (ng/L)Standard Deviation 10.8
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 119.8 nanogram per liter (ng/L)Standard Deviation 10.4
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 516.3 nanogram per liter (ng/L)Standard Deviation 8.03
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1169 nanogram per liter (ng/L)Standard Deviation 280
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 112.2 nanogram per liter (ng/L)Standard Deviation 4.56
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1191 nanogram per liter (ng/L)Standard Deviation 240
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 114.9 nanogram per liter (ng/L)Standard Deviation 6.1
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5125 nanogram per liter (ng/L)Standard Deviation 89.3
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5223 nanogram per liter (ng/L)Standard Deviation 229
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 513.8 nanogram per liter (ng/L)Standard Deviation 7.71
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 131.3 nanogram per liter (ng/L)Standard Deviation 12.7
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 52022 nanogram per liter (ng/L)Standard Deviation 1491
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5173 nanogram per liter (ng/L)Standard Deviation 199
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1883 nanogram per liter (ng/L)Standard Deviation 570
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 553.2 nanogram per liter (ng/L)Standard Deviation 15.3
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 143.3 nanogram per liter (ng/L)Standard Deviation 28.4
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1938 nanogram per liter (ng/L)Standard Deviation 845
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 51145 nanogram per liter (ng/L)Standard Deviation 700
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1254 nanogram per liter (ng/L)Standard Deviation 177
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5802 nanogram per liter (ng/L)Standard Deviation 797
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5129 nanogram per liter (ng/L)Standard Deviation 84.1
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 133.9 nanogram per liter (ng/L)
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1351 nanogram per liter (ng/L)Standard Deviation 448
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 545.1 nanogram per liter (ng/L)Standard Deviation 28.5
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5399 nanogram per liter (ng/L)Standard Deviation 243
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 1108 nanogram per liter (ng/L)Standard Deviation 130
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 5171 nanogram per liter (ng/L)Standard Deviation 78.4
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5585 nanogram per liter (ng/L)Standard Deviation 313
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5252 nanogram per liter (ng/L)Standard Deviation 124
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1148 nanogram per liter (ng/L)Standard Deviation 14.6
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 126.4 nanogram per liter (ng/L)
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 119.8 nanogram per liter (ng/L)Standard Deviation 4.81
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1169 nanogram per liter (ng/L)Standard Deviation 18.1
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5677 nanogram per liter (ng/L)Standard Deviation 751
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 51372 nanogram per liter (ng/L)Standard Deviation 1841
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 115.7 nanogram per liter (ng/L)
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5335 nanogram per liter (ng/L)Standard Deviation 74.3
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 584.8 nanogram per liter (ng/L)Standard Deviation 58.6
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 55240 nanogram per liter (ng/L)Standard Deviation 5279
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 118.0 nanogram per liter (ng/L)
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 11826 nanogram per liter (ng/L)Standard Deviation 3474
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1519 nanogram per liter (ng/L)Standard Deviation 475
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 5141 nanogram per liter (ng/L)Standard Deviation 139
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1323 nanogram per liter (ng/L)Standard Deviation 630
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 143.3 nanogram per liter (ng/L)Standard Deviation 41.9
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 134.7 nanogram per liter (ng/L)Standard Deviation 22.7
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5699 nanogram per liter (ng/L)Standard Deviation 538
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1311 nanogram per liter (ng/L)Standard Deviation 447
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5341 nanogram per liter (ng/L)Standard Deviation 252
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5209 nanogram per liter (ng/L)Standard Deviation 191
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 118.6 nanogram per liter (ng/L)Standard Deviation 4.19
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 5120 nanogram per liter (ng/L)Standard Deviation 178
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5723 nanogram per liter (ng/L)Standard Deviation 1077
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5318 nanogram per liter (ng/L)Standard Deviation 174
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1254 nanogram per liter (ng/L)Standard Deviation 151
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 150.4 nanogram per liter (ng/L)Standard Deviation 22.7
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1211 nanogram per liter (ng/L)Standard Deviation 143
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5162 nanogram per liter (ng/L)Standard Deviation 183
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 195.7 nanogram per liter (ng/L)
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5151 nanogram per liter (ng/L)
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5116 nanogram per liter (ng/L)Standard Deviation 33
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5425 nanogram per liter (ng/L)Standard Deviation 339
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 115.4 nanogram per liter (ng/L)
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 560.3 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 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 123.3 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 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1254 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 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 548.2 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 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1506 nanogram per liter (ng/L)Standard Deviation 137
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5524 nanogram per liter (ng/L)Standard Deviation 180
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 573.3 nanogram per liter (ng/L)Standard Deviation 77.7
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5929 nanogram per liter (ng/L)Standard Deviation 1962
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 177.0 nanogram per liter (ng/L)Standard Deviation 106
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 592.6 nanogram per liter (ng/L)Standard Deviation 86.4
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 170.9 nanogram per liter (ng/L)Standard Deviation 102
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1667 nanogram per liter (ng/L)Standard Deviation 1020
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 51269 nanogram per liter (ng/L)Standard Deviation 1807
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1669 nanogram per liter (ng/L)Standard Deviation 1075
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 121.1 nanogram per liter (ng/L)Standard Deviation 6.39
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 547.7 nanogram per liter (ng/L)Standard Deviation 43.5
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1276 nanogram per liter (ng/L)Standard Deviation 249
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5290 nanogram per liter (ng/L)Standard Deviation 296
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 134.5 nanogram per liter (ng/L)Standard Deviation 15.6
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5513 nanogram per liter (ng/L)Standard Deviation 585
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1274 nanogram per liter (ng/L)Standard Deviation 234
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 594.3 nanogram per liter (ng/L)Standard Deviation 103
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1306 nanogram per liter (ng/L)Standard Deviation 181
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5527 nanogram per liter (ng/L)Standard Deviation 538
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5269 nanogram per liter (ng/L)Standard Deviation 155
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 538.5 nanogram per liter (ng/L)Standard Deviation 22.2
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 119.7 nanogram per liter (ng/L)Standard Deviation 3.87
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 570.9 nanogram per liter (ng/L)Standard Deviation 54.7
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1372 nanogram per liter (ng/L)Standard Deviation 279
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 118.9 nanogram per liter (ng/L)Standard Deviation 3.71
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1706 nanogram per liter (ng/L)Standard Deviation 1757
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1282 nanogram per liter (ng/L)Standard Deviation 176
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5273 nanogram per liter (ng/L)Standard Deviation 244
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 564.4 nanogram per liter (ng/L)Standard Deviation 61.5
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 554.0 nanogram per liter (ng/L)Standard Deviation 36.1
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5269 nanogram per liter (ng/L)Standard Deviation 174
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 162.4 nanogram per liter (ng/L)Standard Deviation 20.7
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 184.4 nanogram per liter (ng/L)Standard Deviation 87.8
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1200 nanogram per liter (ng/L)Standard Deviation 101
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5165 nanogram per liter (ng/L)Standard Deviation 98.6
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5390 nanogram per liter (ng/L)Standard Deviation 530
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 5326 nanogram per liter (ng/L)Standard Deviation 124
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 51049 nanogram per liter (ng/L)Standard Deviation 1288
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1718 nanogram per liter (ng/L)Standard Deviation 649
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 168.3 nanogram per liter (ng/L)
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 143.5 nanogram per liter (ng/L)
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 1264 nanogram per liter (ng/L)Standard Deviation 379
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 131.7 nanogram per liter (ng/L)Standard Deviation 24.2
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 5279 nanogram per liter (ng/L)Standard Deviation 526
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 125.8 nanogram per liter (ng/L)Standard Deviation 1.04
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 5101 nanogram per liter (ng/L)Standard Deviation 71
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 1757 nanogram per liter (ng/L)Standard Deviation 2165
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5635 nanogram per liter (ng/L)Standard Deviation 500
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5267 nanogram per liter (ng/L)Standard Deviation 172
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 2 Day 541.9 nanogram per liter (ng/L)Standard Deviation 1.42
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)INF-γ: Cycle 1 Day 587.7 nanogram per liter (ng/L)Standard Deviation 42.1
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 2 Day 5123 nanogram per liter (ng/L)Standard Deviation 19
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)IL-6: Cycle 1 Day 5232 nanogram per liter (ng/L)Standard Deviation 13.8
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts 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) CellsNK Cells197 cells per microliters (cells/mcL)Standard Deviation 61.4
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts 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) CellsWhole 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/kgParts 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) CellsTotal CD8+ T Cells247 cells per microliters (cells/mcL)Standard Deviation 107
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts 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) CellsWhole 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/kgParts 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) CellsTotal CD8+ T Cells204 cells per microliters (cells/mcL)Standard Deviation 89.2
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts 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) CellsNK Cells343 cells per microliters (cells/mcL)Standard Deviation 20.6
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts 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) CellsTotal CD8+ T Cells262 cells per microliters (cells/mcL)Standard Deviation 64.2
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts 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) CellsWhole Blood FoxP3+ T Cells (Tregs)56.6 cells per microliters (cells/mcL)Standard Deviation 22.3
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts 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) CellsNK Cells467 cells per microliters (cells/mcL)Standard Deviation 313
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts 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) CellsNK Cells685 cells per microliters (cells/mcL)Standard Deviation 307
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts 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) CellsWhole Blood FoxP3+ T Cells (Tregs)46.3 cells per microliters (cells/mcL)Standard Deviation 21.8
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts 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) CellsTotal CD8+ T Cells466 cells per microliters (cells/mcL)Standard Deviation 255
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsTotal CD8+ T Cells610 cells per microliters (cells/mcL)Standard Deviation 570
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsWhole Blood FoxP3+ T Cells (Tregs)43.3 cells per microliters (cells/mcL)Standard Deviation 28.2
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsNK Cells1053 cells per microliters (cells/mcL)Standard Deviation 660
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts 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) CellsNK Cells978 cells per microliters (cells/mcL)Standard Deviation 400
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts 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) CellsWhole Blood FoxP3+ T Cells (Tregs)57.4 cells per microliters (cells/mcL)Standard Deviation 14.4
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts 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) CellsTotal CD8+ T Cells704 cells per microliters (cells/mcL)Standard Deviation 559
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts 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) CellsNK Cells1038 cells per microliters (cells/mcL)Standard Deviation 1028
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts 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) CellsWhole Blood FoxP3+ T Cells (Tregs)51.3 cells per microliters (cells/mcL)Standard Deviation 36
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts 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) CellsTotal CD8+ T Cells703 cells per microliters (cells/mcL)Standard Deviation 502
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsWhole 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/kgParts 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) CellsTotal CD8+ T Cells1392 cells per microliters (cells/mcL)Standard Deviation 1053
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsNK Cells1279 cells per microliters (cells/mcL)Standard Deviation 642
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsTotal CD8+ T Cells773 cells per microliters (cells/mcL)Standard Deviation 422
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsNK Cells1470 cells per microliters (cells/mcL)Standard Deviation 873
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts 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) CellsWhole 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/kgParts 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) CellsTotal CD8+ T Cells262 cells per microliters (cells/mcL)Standard Deviation 186
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts 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) CellsWhole 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/kgParts 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) CellsNK Cells531 cells per microliters (cells/mcL)Standard Deviation 296
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts 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) CellsTotal CD8+ T Cells551 cells per microliters (cells/mcL)Standard Deviation 433
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts 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) CellsNK Cells804 cells per microliters (cells/mcL)Standard Deviation 196
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts 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) CellsWhole 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 mgParts 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) CellsTotal CD8+ T Cells562 cells per microliters (cells/mcL)Standard Deviation 373
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts 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) CellsNK Cells771 cells per microliters (cells/mcL)Standard Deviation 503
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts 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) CellsWhole 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 mgParts 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) CellsWhole 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 mgParts 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) CellsTotal CD8+ T Cells533 cells per microliters (cells/mcL)Standard Deviation 328
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts 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) CellsNK Cells760 cells per microliters (cells/mcL)Standard Deviation 458
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts 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) CellsWhole 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 mgParts 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) CellsNK Cells813 cells per microliters (cells/mcL)Standard Deviation 436
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts 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) CellsTotal CD8+ T Cells688 cells per microliters (cells/mcL)Standard Deviation 384
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts 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) CellsTotal CD8+ T Cells718 cells per microliters (cells/mcL)Standard Deviation 567
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts 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) CellsWhole 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 mgParts 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) CellsNK Cells889 cells per microliters (cells/mcL)Standard Deviation 438
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts 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) CellsWhole 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 mgParts 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) CellsTotal CD8+ T Cells924 cells per microliters (cells/mcL)Standard Deviation 638
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts 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) CellsNK Cells1081 cells per microliters (cells/mcL)Standard Deviation 787
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts 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) CellsTotal CD8+ T Cells762 cells per microliters (cells/mcL)Standard Deviation 538
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts 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) CellsNK Cells1064 cells per microliters (cells/mcL)Standard Deviation 445
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts 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) CellsWhole 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 mgParts 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) CellsTotal CD8+ T Cells445 cells per microliters (cells/mcL)Standard Deviation 349
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts 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) CellsWhole 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 mgParts 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) CellsNK Cells1298 cells per microliters (cells/mcL)Standard Deviation 334
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 11.72 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 35.1
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 51.99 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 10.3
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 51.90 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 11
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 12.09 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 41.4
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 15.34 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 2.2
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 16.72 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 21.3
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 56.36 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 24.5
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 56.39 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 12.7
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 537.4 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 19.2
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 119.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 32.3
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 120.5 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 26.8
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 516.7 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 18.5
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 147.6 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 177.8
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 552.9 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 48.1
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 541.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 178.7
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 165.3 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 27.5
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 597.4 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 29
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1113 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 24.7
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 1113 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 33.7
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 5108 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 22.5
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 5112 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 13.5
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 1151 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 36.7
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1112 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 13
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 595.7 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 37
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 583.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 57.4
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 5104 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 12.5
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1116 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 33.1
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 1157 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 19.4
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 199.4 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 40.8
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1108 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 86.7
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 5103 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 69.5
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 582.1 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 32.3
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 595.1 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 33.8
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 1124 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 34.2
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1119 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 27.6
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 599.6 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 18.3
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 115.6 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 18.1
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 118.1 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 15.4
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 519.2 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 21.7
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 514.6 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 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 165.6 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 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 546.5 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 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 152.9 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 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 540.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 26.9
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 555.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 37.5
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 161.4 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 22.8
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 155.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 26.9
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 550.3 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 67.9
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 158.1 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 81.2
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 553.1 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 57.9
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 157.5 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 86.5
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 551.7 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 52
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 551.0 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 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 554.4 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 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 155.6 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 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 159.5 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 32.6
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 547.0 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 40.1
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 145.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 48.8
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 147.2 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 47.7
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 549.8 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 52.6
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 599.2 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 20.3
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 1131 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 15.8
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 5118 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 1.8
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1112 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 15.3
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 5101 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 51.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1128 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 30.6
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 1133 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 31.7
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 596.6 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 29.7
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 189.3 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 3
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 1124 nanograms per milliliters (ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 1 Day 5104 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 1.8
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin AlfaCycle 2 Day 594.4 nanograms per milliliters (ng/mL)Geometric Coefficient of Variation 12.5
Secondary

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.

ArmMeasureValue (NUMBER)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts 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/kgParts 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/kgParts 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/kgParts 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/kgParts 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/kgParts 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/kgParts 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/kgParts 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/kgParts 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/kgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts 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 mgParts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA)0.00 proportion of participants
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours0.909 nanograms per milliliter (ng/mL)Standard Deviation 0.164
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 16 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour1.44 nanograms per milliliter (ng/mL)Standard Deviation 0.26
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 16 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 16 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour1.92 nanograms per milliliter (ng/mL)Standard Deviation 0.296
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour1.61 nanograms per milliliter (ng/mL)Standard Deviation 0.265
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours0.965 nanograms per milliliter (ng/mL)Standard Deviation 0.0894
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours0.142 nanograms per milliliter (ng/mL)Standard Deviation 0.318
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours0.889 nanograms per milliliter (ng/mL)Standard Deviation 0.174
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 16 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour2.24 nanograms per milliliter (ng/mL)Standard Deviation 1.06
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour1.36 nanograms per milliliter (ng/mL)Standard Deviation 0.646
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour1.80 nanograms per milliliter (ng/mL)Standard Deviation 0.59
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours0.988 nanograms per milliliter (ng/mL)Standard Deviation 0.0219
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour2.00 nanograms per milliliter (ng/mL)Standard Deviation 0.238
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour1.55 nanograms per milliliter (ng/mL)Standard Deviation 0.245
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours1.31 nanograms per milliliter (ng/mL)Standard Deviation 0.422
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours0.205 nanograms per milliliter (ng/mL)Standard Deviation 0.41
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours3.43 nanograms per milliliter (ng/mL)Standard Deviation 0.797
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour4.84 nanograms per milliliter (ng/mL)Standard Deviation 0.806
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour5.42 nanograms per milliliter (ng/mL)
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour6.06 nanograms per milliliter (ng/mL)Standard Deviation 0.454
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 16 hours0.158 nanograms per milliliter (ng/mL)Standard Deviation 0.316
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours1.17 nanograms per milliliter (ng/mL)Standard Deviation 0.45
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour4.82 nanograms per milliliter (ng/mL)Standard Deviation 0.794
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours3.53 nanograms per milliliter (ng/mL)Standard Deviation 1.1
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour5.28 nanograms per milliliter (ng/mL)Standard Deviation 1.07
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour6.00 nanograms per milliliter (ng/mL)Standard Deviation 1.45
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours2.84 nanograms per milliliter (ng/mL)Standard Deviation 0.751
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 16 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 16 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours0.453 nanograms per milliliter (ng/mL)Standard Deviation 0.314
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours1.13 nanograms per milliliter (ng/mL)Standard Deviation 0.471
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours1.87 nanograms per milliliter (ng/mL)Standard Deviation 0.71
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours3.83 nanograms per milliliter (ng/mL)Standard Deviation 1.01
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour5.67 nanograms per milliliter (ng/mL)Standard Deviation 1.61
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 16 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour6.13 nanograms per milliliter (ng/mL)Standard Deviation 0.653
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours2.32 nanograms per milliliter (ng/mL)Standard Deviation 1.45
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours9.26 nanograms per milliliter (ng/mL)Standard Deviation 5.76
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours1.27 nanograms per milliliter (ng/mL)Standard Deviation 0.509
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour13.8 nanograms per milliliter (ng/mL)Standard Deviation 7.79
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour20.1 nanograms per milliliter (ng/mL)Standard Deviation 8.08
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour0.0868 nanograms per milliliter (ng/mL)Standard Deviation 0.213
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour0.104 nanograms per milliliter (ng/mL)Standard Deviation 0.276
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour20.1 nanograms per milliliter (ng/mL)Standard Deviation 5.32
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours9.09 nanograms per milliliter (ng/mL)Standard Deviation 3.13
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour20.7 nanograms per milliliter (ng/mL)Standard Deviation 6.83
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours0.106 nanograms per milliliter (ng/mL)Standard Deviation 0.28
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 16 hours0.522 nanograms per milliliter (ng/mL)Standard Deviation 0.641
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour17.3 nanograms per milliliter (ng/mL)Standard Deviation 5.46
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours2.55 nanograms per milliliter (ng/mL)Standard Deviation 1.27
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours12.6 nanograms per milliliter (ng/mL)Standard Deviation 4.4
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours4.18 nanograms per milliliter (ng/mL)Standard Deviation 1.98
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 16 hours0.405 nanograms per milliliter (ng/mL)Standard Deviation 0.701
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours6.97 nanograms per milliliter (ng/mL)Standard Deviation 2.25
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours12.3 nanograms per milliliter (ng/mL)Standard Deviation 2.8
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour16.6 nanograms per milliliter (ng/mL)Standard Deviation 3.84
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 24 hours0.147 nanograms per milliliter (ng/mL)Standard Deviation 0.294
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 16 hours0.218 nanograms per milliliter (ng/mL)Standard Deviation 0.378
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour17.2 nanograms per milliliter (ng/mL)Standard Deviation 3.44
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 16 hours0.244 nanograms per milliliter (ng/mL)Standard Deviation 0.488
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours0.219 nanograms per milliliter (ng/mL)Standard Deviation 0.342
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours1.16 nanograms per milliliter (ng/mL)Standard Deviation 1.31
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours4.17 nanograms per milliliter (ng/mL)Standard Deviation 3.72
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours7.16 nanograms per milliliter (ng/mL)Standard Deviation 3.53
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour14.7 nanograms per milliliter (ng/mL)Standard Deviation 3.8
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 16 hours0.625 nanograms per milliliter (ng/mL)Standard Deviation 0.586
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours14.9 nanograms per milliliter (ng/mL)Standard Deviation 6.75
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour69.1 nanograms per milliliter (ng/mL)Standard Deviation 16.8
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour48.9 nanograms per milliliter (ng/mL)Standard Deviation 26.6
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours25.2 nanograms per milliliter (ng/mL)Standard Deviation 11.7
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours3.89 nanograms per milliliter (ng/mL)Standard Deviation 1.58
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour0.914 nanograms per milliliter (ng/mL)Standard Deviation 0.614
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour71.3 nanograms per milliliter (ng/mL)Standard Deviation 14
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 16 hours1.15 nanograms per milliliter (ng/mL)Standard Deviation 0.687
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 16 hours2.47 nanograms per milliliter (ng/mL)Standard Deviation 2.14
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour0.619 nanograms per milliliter (ng/mL)Standard Deviation 0.462
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours44.9 nanograms per milliliter (ng/mL)Standard Deviation 14.5
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours9.29 nanograms per milliliter (ng/mL)Standard Deviation 4.62
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours44.0 nanograms per milliliter (ng/mL)Standard Deviation 18.5
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour44.9 nanograms per milliliter (ng/mL)Standard Deviation 18.3
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.200 nanograms per milliliter (ng/mL)Standard Deviation 0.347
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours29.9 nanograms per milliliter (ng/mL)Standard Deviation 12.3
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 24 hours0.631 nanograms per milliliter (ng/mL)Standard Deviation 0.63
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours3.25 nanograms per milliliter (ng/mL)Standard Deviation 1.84
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours1.19 nanograms per milliliter (ng/mL)Standard Deviation 0.633
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours0.940 nanograms per milliliter (ng/mL)Standard Deviation 0.561
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour72.2 nanograms per milliliter (ng/mL)Standard Deviation 13
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 16 hours1.50 nanograms per milliliter (ng/mL)Standard Deviation 1.2
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour58.8 nanograms per milliliter (ng/mL)Standard Deviation 25.3
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours30.1 nanograms per milliliter (ng/mL)Standard Deviation 18.1
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour77.9 nanograms per milliliter (ng/mL)Standard Deviation 15.5
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours10.0 nanograms per milliliter (ng/mL)Standard Deviation 4.85
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 24 hours0.221 nanograms per milliliter (ng/mL)Standard Deviation 0.382
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour58.3 nanograms per milliliter (ng/mL)Standard Deviation 11.8
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours12.9 nanograms per milliliter (ng/mL)Standard Deviation 7.19
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours27.8 nanograms per milliliter (ng/mL)Standard Deviation 10.6
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour109 nanograms per milliliter (ng/mL)Standard Deviation 29.6
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 16 hours4.24 nanograms per milliliter (ng/mL)Standard Deviation 3.6
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours2.11 nanograms per milliliter (ng/mL)Standard Deviation 1.45
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour1.36 nanograms per milliliter (ng/mL)Standard Deviation 0.589
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour93.9 nanograms per milliliter (ng/mL)Standard Deviation 22.2
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour84.8 nanograms per milliliter (ng/mL)Standard Deviation 23.7
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours58.4 nanograms per milliliter (ng/mL)Standard Deviation 19.3
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours27.1 nanograms per milliliter (ng/mL)Standard Deviation 10.4
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours6.93 nanograms per milliliter (ng/mL)Standard Deviation 3.91
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 16 hours1.64 nanograms per milliliter (ng/mL)Standard Deviation 0.597
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 24 hours1.38 nanograms per milliliter (ng/mL)Standard Deviation 0.697
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.488 nanograms per milliliter (ng/mL)Standard Deviation 0.376
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour112 nanograms per milliliter (ng/mL)Standard Deviation 24.5
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours83.0 nanograms per milliliter (ng/mL)Standard Deviation 19.6
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours51.4 nanograms per milliliter (ng/mL)Standard Deviation 15.9
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours21.6 nanograms per milliliter (ng/mL)Standard Deviation 7.61
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 16 hours7.27 nanograms per milliliter (ng/mL)Standard Deviation 4.49
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours2.95 nanograms per milliliter (ng/mL)Standard Deviation 1.61
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour2.36 nanograms per milliliter (ng/mL)Standard Deviation 2.29
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour111 nanograms per milliliter (ng/mL)Standard Deviation 26
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour87.6 nanograms per milliliter (ng/mL)Standard Deviation 14.7
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours65.2 nanograms per milliliter (ng/mL)Standard Deviation 22.1
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours32.0 nanograms per milliliter (ng/mL)Standard Deviation 14
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours6.67 nanograms per milliliter (ng/mL)Standard Deviation 2.74
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 16 hours1.65 nanograms per milliliter (ng/mL)Standard Deviation 0.707
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 24 hours1.38 nanograms per milliliter (ng/mL)Standard Deviation 0.631
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.498 nanograms per milliliter (ng/mL)Standard Deviation 0.596
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour8.24 nanograms per milliliter (ng/mL)Standard Deviation 24.7
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours16.5 nanograms per milliliter (ng/mL)Standard Deviation 7.44
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour105 nanograms per milliliter (ng/mL)Standard Deviation 23.9
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour94.6 nanograms per milliliter (ng/mL)Standard Deviation 14.3
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours74.5 nanograms per milliliter (ng/mL)Standard Deviation 18.2
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours45.1 nanograms per milliliter (ng/mL)Standard Deviation 14
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours18.7 nanograms per milliliter (ng/mL)Standard Deviation 9.48
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour2.24 nanograms per milliliter (ng/mL)Standard Deviation 1.46
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours57.4 nanograms per milliliter (ng/mL)Standard Deviation 11.9
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours24.2 nanograms per milliliter (ng/mL)Standard Deviation 2.26
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.611 nanograms per milliliter (ng/mL)Standard Deviation 0.625
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours5.74 nanograms per milliliter (ng/mL)Standard Deviation 0.0933
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours59.0 nanograms per milliliter (ng/mL)Standard Deviation 6.87
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour90.5 nanograms per milliliter (ng/mL)Standard Deviation 16.3
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours66.4 nanograms per milliliter (ng/mL)Standard Deviation 6.97
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour1.59 nanograms per milliliter (ng/mL)Standard Deviation 0.692
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours76.9 nanograms per milliliter (ng/mL)Standard Deviation 23.3
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours50.5 nanograms per milliliter (ng/mL)Standard Deviation 16.2
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours3.21 nanograms per milliliter (ng/mL)Standard Deviation 0.253
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour157 nanograms per milliliter (ng/mL)Standard Deviation 56.8
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours29.1 nanograms per milliliter (ng/mL)Standard Deviation 7.92
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour98.4 nanograms per milliliter (ng/mL)Standard Deviation 10.5
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour132 nanograms per milliliter (ng/mL)Standard Deviation 33
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours6.68 nanograms per milliliter (ng/mL)Standard Deviation 1.85
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour105 nanograms per milliliter (ng/mL)Standard Deviation 27.7
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours24.9 nanograms per milliliter (ng/mL)Standard Deviation 9.77
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour113 nanograms per milliliter (ng/mL)Standard Deviation 15.1
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour98.8 nanograms per milliliter (ng/mL)Standard Deviation 34.7
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour112 nanograms per milliliter (ng/mL)Standard Deviation 14.6
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.824 nanograms per milliliter (ng/mL)Standard Deviation 0.333
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours1.81 nanograms per milliliter (ng/mL)Standard Deviation 1.3
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours98.9 nanograms per milliliter (ng/mL)Standard Deviation 21.8
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours28.0 nanograms per milliliter (ng/mL)Standard Deviation 14
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.664 nanograms per milliliter (ng/mL)Standard Deviation 0.597
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour2.36 nanograms per milliliter (ng/mL)Standard Deviation 1.11
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours24.9 nanograms per milliliter (ng/mL)Standard Deviation 13.1
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours2.51 nanograms per milliliter (ng/mL)Standard Deviation 1.19
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour121 nanograms per milliliter (ng/mL)Standard Deviation 40.4
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours62.1 nanograms per milliliter (ng/mL)Standard Deviation 26.5
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours5.06 nanograms per milliliter (ng/mL)Standard Deviation 1.68
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour78.4 nanograms per milliliter (ng/mL)Standard Deviation 39.9
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours100 nanograms per milliliter (ng/mL)Standard Deviation 27.1
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour70.3 nanograms per milliliter (ng/mL)Standard Deviation 9.27
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours24.3 nanograms per milliliter (ng/mL)Standard Deviation 11.6
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours49.9 nanograms per milliliter (ng/mL)Standard Deviation 15.2
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours1.57 nanograms per milliliter (ng/mL)Standard Deviation 0.584
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours31.2 nanograms per milliliter (ng/mL)Standard Deviation 16.9
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours7.51 nanograms per milliliter (ng/mL)Standard Deviation 3.23
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour91.2 nanograms per milliliter (ng/mL)Standard Deviation 40.2
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour102 nanograms per milliliter (ng/mL)Standard Deviation 33.2
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour148 nanograms per milliliter (ng/mL)Standard Deviation 18.2
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour1.67 nanograms per milliliter (ng/mL)Standard Deviation 0.531
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours52.5 nanograms per milliliter (ng/mL)Standard Deviation 15.8
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour135 nanograms per milliliter (ng/mL)Standard Deviation 33.9
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours66.2 nanograms per milliliter (ng/mL)Standard Deviation 15.1
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours5.18 nanograms per milliliter (ng/mL)Standard Deviation 4.2
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour104 nanograms per milliliter (ng/mL)Standard Deviation 13
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours85.9 nanograms per milliliter (ng/mL)Standard Deviation 26.8
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour78.0 nanograms per milliliter (ng/mL)Standard Deviation 29.5
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours46.8 nanograms per milliliter (ng/mL)Standard Deviation 16.5
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour85.1 nanograms per milliliter (ng/mL)Standard Deviation 28.1
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.578 nanograms per milliliter (ng/mL)Standard Deviation 0.475
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours7.94 nanograms per milliliter (ng/mL)Standard Deviation 6.53
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour102 nanograms per milliliter (ng/mL)Standard Deviation 36.1
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours76.7 nanograms per milliliter (ng/mL)Standard Deviation 26.5
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours2.03 nanograms per milliliter (ng/mL)Standard Deviation 1.69
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour93.3 nanograms per milliliter (ng/mL)Standard Deviation 34.9
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour101 nanograms per milliliter (ng/mL)Standard Deviation 32.3
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour174 nanograms per milliliter (ng/mL)Standard Deviation 372
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours26.8 nanograms per milliliter (ng/mL)Standard Deviation 35.4
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours77.4 nanograms per milliliter (ng/mL)Standard Deviation 21.5
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour2.11 nanograms per milliliter (ng/mL)Standard Deviation 13.7
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours27.6 nanograms per milliliter (ng/mL)Standard Deviation 8.71
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours50.1 nanograms per milliliter (ng/mL)Standard Deviation 16.2
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.0137 nanograms per milliliter (ng/mL)Standard Deviation 0.0917
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour1.58 nanograms per milliliter (ng/mL)Standard Deviation 0.653
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.623 nanograms per milliliter (ng/mL)Standard Deviation 0.973
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour153 nanograms per milliliter (ng/mL)Standard Deviation 300
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours31.8 nanograms per milliliter (ng/mL)Standard Deviation 28.9
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours6.78 nanograms per milliliter (ng/mL)Standard Deviation 3.25
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours39.4 nanograms per milliliter (ng/mL)Standard Deviation 43.2
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours55.3 nanograms per milliliter (ng/mL)Standard Deviation 20.9
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours3.64 nanograms per milliliter (ng/mL)Standard Deviation 1.9
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours57.8 nanograms per milliliter (ng/mL)Standard Deviation 20.2
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour94.8 nanograms per milliliter (ng/mL)Standard Deviation 104
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour1.51 nanograms per milliliter (ng/mL)Standard Deviation 0.654
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours24.1 nanograms per milliliter (ng/mL)Standard Deviation 8.09
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours1.95 nanograms per milliliter (ng/mL)Standard Deviation 0.854
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours87.9 nanograms per milliliter (ng/mL)Standard Deviation 23.5
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour83.4 nanograms per milliliter (ng/mL)Standard Deviation 19.4
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours32.5 nanograms per milliliter (ng/mL)Standard Deviation 7.83
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours3.53 nanograms per milliliter (ng/mL)Standard Deviation 1.25
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours30.3 nanograms per milliliter (ng/mL)Standard Deviation 6.2
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour83.8 nanograms per milliliter (ng/mL)Standard Deviation 14.8
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour101 nanograms per milliliter (ng/mL)Standard Deviation 29.2
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours61.0 nanograms per milliliter (ng/mL)Standard Deviation 14.3
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour1.96 nanograms per milliliter (ng/mL)Standard Deviation 0.987
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours6.49 nanograms per milliliter (ng/mL)Standard Deviation 2.96
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours29.1 nanograms per milliliter (ng/mL)Standard Deviation 10.4
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.120 nanograms per milliliter (ng/mL)Standard Deviation 0.41
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour117 nanograms per milliliter (ng/mL)Standard Deviation 19.9
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.396 nanograms per milliliter (ng/mL)Standard Deviation 0.45
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours66.4 nanograms per milliliter (ng/mL)Standard Deviation 15.9
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour106 nanograms per milliliter (ng/mL)Standard Deviation 30.3
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours57.1 nanograms per milliliter (ng/mL)Standard Deviation 14.9
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.0329 nanograms per milliliter (ng/mL)Standard Deviation 0.171
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour131 nanograms per milliliter (ng/mL)Standard Deviation 51.3
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour1.72 nanograms per milliliter (ng/mL)Standard Deviation 0.599
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour101 nanograms per milliliter (ng/mL)Standard Deviation 18.6
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.538 nanograms per milliliter (ng/mL)Standard Deviation 0.383
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours6.33 nanograms per milliliter (ng/mL)Standard Deviation 2.04
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours97.6 nanograms per milliliter (ng/mL)Standard Deviation 21.7
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours62.0 nanograms per milliliter (ng/mL)Standard Deviation 17.8
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour123 nanograms per milliliter (ng/mL)Standard Deviation 31.7
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour0.209 nanograms per milliliter (ng/mL)Standard Deviation 0.361
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours2.51 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour15.8 nanograms per milliliter (ng/mL)Standard Deviation 2.82
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours4.49 nanograms per milliliter (ng/mL)Standard Deviation 1.26
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours1.86 nanograms per milliliter (ng/mL)Standard Deviation 0.257
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour18.9 nanograms per milliliter (ng/mL)Standard Deviation 2.5
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour17.4 nanograms per milliliter (ng/mL)Standard Deviation 5.33
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour13.4 nanograms per milliliter (ng/mL)Standard Deviation 3.07
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours6.18 nanograms per milliliter (ng/mL)Standard Deviation 0.687
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours1.47 nanograms per milliliter (ng/mL)Standard Deviation 0.445
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours7.00 nanograms per milliliter (ng/mL)Standard Deviation 0.412
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours10.3 nanograms per milliliter (ng/mL)Standard Deviation 4.44
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour19.5 nanograms per milliliter (ng/mL)Standard Deviation 3.9
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour13.7 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour16.8 nanograms per milliliter (ng/mL)Standard Deviation 5.53
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours6.40 nanograms per milliliter (ng/mL)Standard Deviation 2.13
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours0.498 nanograms per milliliter (ng/mL)Standard Deviation 0.704
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours13.1 nanograms per milliliter (ng/mL)Standard Deviation 0.626
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour18.6 nanograms per milliliter (ng/mL)Standard Deviation 3.94
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours8.74 nanograms per milliliter (ng/mL)Standard Deviation 1.5
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours14.0 nanograms per milliliter (ng/mL)Standard Deviation 2.74
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour0.180 nanograms per milliliter (ng/mL)Standard Deviation 0.312
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours11.3 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours28.2 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour67.1 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour50.0 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours8.11 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours38.7 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours21.9 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours9.63 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours21.3 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 16 hours0.00 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours1.46 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour0.416 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour49.5 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour33.8 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour45.6 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours31.8 nanograms per milliliter (ng/mL)Standard Deviation 17
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours13.1 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour44.3 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours19.5 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours3.39 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour0.756 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours8.66 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour56.3 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours0.737 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour48.2 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 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours35.6 nanograms per milliliter (ng/mL)Standard Deviation 8.32
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours42.5 nanograms per milliliter (ng/mL)Standard Deviation 9.2
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours1.06 nanograms per milliliter (ng/mL)Standard Deviation 1.06
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours10.2 nanograms per milliliter (ng/mL)Standard Deviation 2.88
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours3.33 nanograms per milliliter (ng/mL)Standard Deviation 1.87
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour1.10 nanograms per milliliter (ng/mL)Standard Deviation 0.965
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour69.8 nanograms per milliliter (ng/mL)Standard Deviation 124
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour61.7 nanograms per milliliter (ng/mL)Standard Deviation 13.4
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour2.14 nanograms per milliliter (ng/mL)Standard Deviation 6.54
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour57.8 nanograms per milliliter (ng/mL)Standard Deviation 15.4
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours28.6 nanograms per milliliter (ng/mL)Standard Deviation 9.1
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour47.2 nanograms per milliliter (ng/mL)Standard Deviation 12.7
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours3.41 nanograms per milliliter (ng/mL)Standard Deviation 1.66
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours1.64 nanograms per milliliter (ng/mL)Standard Deviation 1.44
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.0170 nanograms per milliliter (ng/mL)Standard Deviation 0.0945
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours13.2 nanograms per milliliter (ng/mL)Standard Deviation 5.51
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours12.0 nanograms per milliliter (ng/mL)Standard Deviation 4.47
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours38.8 nanograms per milliliter (ng/mL)Standard Deviation 9.33
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours25.6 nanograms per milliliter (ng/mL)Standard Deviation 5.22
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours7.91 nanograms per milliliter (ng/mL)Standard Deviation 3.47
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour58.3 nanograms per milliliter (ng/mL)Standard Deviation 25.3
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours30.6 nanograms per milliliter (ng/mL)Standard Deviation 9.57
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour64.2 nanograms per milliliter (ng/mL)Standard Deviation 60.1
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour51.5 nanograms per milliliter (ng/mL)Standard Deviation 10
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours25.1 nanograms per milliliter (ng/mL)Standard Deviation 12.7
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour56.3 nanograms per milliliter (ng/mL)Standard Deviation 11.2
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour54.2 nanograms per milliliter (ng/mL)Standard Deviation 14.2
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour42.7 nanograms per milliliter (ng/mL)Standard Deviation 12.9
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.210 nanograms per milliliter (ng/mL)Standard Deviation 0.419
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours10.8 nanograms per milliliter (ng/mL)Standard Deviation 4.41
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours4.85 nanograms per milliliter (ng/mL)Standard Deviation 3.63
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours8.85 nanograms per milliliter (ng/mL)Standard Deviation 3.92
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour0.922 nanograms per milliliter (ng/mL)Standard Deviation 0.67
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours24.0 nanograms per milliliter (ng/mL)Standard Deviation 7.15
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour47.3 nanograms per milliliter (ng/mL)Standard Deviation 12.2
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour79.6 nanograms per milliliter (ng/mL)Standard Deviation 93.1
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour71.5 nanograms per milliliter (ng/mL)Standard Deviation 51.7
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours1.64 nanograms per milliliter (ng/mL)Standard Deviation 1.42
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours14.8 nanograms per milliliter (ng/mL)Standard Deviation 6
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours3.99 nanograms per milliliter (ng/mL)Standard Deviation 1.69
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours31.8 nanograms per milliliter (ng/mL)Standard Deviation 9.39
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours43.6 nanograms per milliliter (ng/mL)Standard Deviation 11.5
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour2.16 nanograms per milliliter (ng/mL)Standard Deviation 3.95
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours1.16 nanograms per milliliter (ng/mL)Standard Deviation 0.777
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours29.9 nanograms per milliliter (ng/mL)Standard Deviation 9.94
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour61.6 nanograms per milliliter (ng/mL)Standard Deviation 25.5
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour63.6 nanograms per milliliter (ng/mL)Standard Deviation 41.8
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours17.2 nanograms per milliliter (ng/mL)Standard Deviation 18.5
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours38.3 nanograms per milliliter (ng/mL)Standard Deviation 11.1
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours27.6 nanograms per milliliter (ng/mL)Standard Deviation 7.91
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour58.8 nanograms per milliliter (ng/mL)Standard Deviation 38.5
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour52.7 nanograms per milliliter (ng/mL)Standard Deviation 14.4
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours13.3 nanograms per milliliter (ng/mL)Standard Deviation 5.22
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour47.8 nanograms per milliliter (ng/mL)Standard Deviation 13
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours1.29 nanograms per milliliter (ng/mL)Standard Deviation 0.749
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour62.5 nanograms per milliliter (ng/mL)Standard Deviation 20.2
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours27.4 nanograms per milliliter (ng/mL)Standard Deviation 9.8
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour61.1 nanograms per milliliter (ng/mL)Standard Deviation 30.1
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours1.15 nanograms per milliliter (ng/mL)Standard Deviation 1.4
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 16 hours4.95 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours28.5 nanograms per milliliter (ng/mL)Standard Deviation 9.68
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours13.0 nanograms per milliliter (ng/mL)Standard Deviation 7.01
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours3.94 nanograms per milliliter (ng/mL)Standard Deviation 1.97
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours10.8 nanograms per milliliter (ng/mL)Standard Deviation 4.29
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours3.26 nanograms per milliliter (ng/mL)Standard Deviation 1.32
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 16 hours1.97 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour41.9 nanograms per milliliter (ng/mL)Standard Deviation 11.7
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour1.01 nanograms per milliliter (ng/mL)Standard Deviation 1.71
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours21.4 nanograms per milliliter (ng/mL)Standard Deviation 8.75
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour42.3 nanograms per milliliter (ng/mL)Standard Deviation 15.5
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.103 nanograms per milliliter (ng/mL)Standard Deviation 0.273
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours26.4 nanograms per milliliter (ng/mL)Standard Deviation 8.67
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour2.10 nanograms per milliliter (ng/mL)Standard Deviation 9.24
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours42.6 nanograms per milliliter (ng/mL)Standard Deviation 13.8
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours7.40 nanograms per milliliter (ng/mL)Standard Deviation 3.67
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours37.1 nanograms per milliliter (ng/mL)Standard Deviation 10.5
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour0.933 nanograms per milliliter (ng/mL)Standard Deviation 0.529
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour57.5 nanograms per milliliter (ng/mL)Standard Deviation 17.9
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour55.7 nanograms per milliliter (ng/mL)Standard Deviation 22.7
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours11.8 nanograms per milliliter (ng/mL)Standard Deviation 11.9
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours35.6 nanograms per milliliter (ng/mL)Standard Deviation 30.6
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours2.94 nanograms per milliliter (ng/mL)Standard Deviation 6.88
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours34.0 nanograms per milliliter (ng/mL)Standard Deviation 18.8
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour43.0 nanograms per milliliter (ng/mL)Standard Deviation 27.4
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours25.2 nanograms per milliliter (ng/mL)Standard Deviation 32.6
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours12.8 nanograms per milliliter (ng/mL)Standard Deviation 18.3
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours17.7 nanograms per milliliter (ng/mL)Standard Deviation 16.2
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours22.5 nanograms per milliliter (ng/mL)Standard Deviation 13.6
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour56.7 nanograms per milliliter (ng/mL)Standard Deviation 31.1
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour51.1 nanograms per milliliter (ng/mL)Standard Deviation 28
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours36.7 nanograms per milliliter (ng/mL)Standard Deviation 27.9
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour49.9 nanograms per milliliter (ng/mL)Standard Deviation 37
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour4.17 nanograms per milliliter (ng/mL)Standard Deviation 8.72
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour3.90 nanograms per milliliter (ng/mL)Standard Deviation 9.89
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours4.96 nanograms per milliliter (ng/mL)Standard Deviation 11.7
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours24.1 nanograms per milliliter (ng/mL)Standard Deviation 19.1
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours7.80 nanograms per milliliter (ng/mL)Standard Deviation 12.3
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour45.0 nanograms per milliliter (ng/mL)Standard Deviation 28.2
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour51.8 nanograms per milliliter (ng/mL)Standard Deviation 29.6
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour48.1 nanograms per milliliter (ng/mL)Standard Deviation 28.2
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 16 hours1.69 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.0151 nanograms per milliliter (ng/mL)Standard Deviation 0.0988
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours12.2 nanograms per milliliter (ng/mL)Standard Deviation 19.7
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours39.6 nanograms per milliliter (ng/mL)Standard Deviation 38.3
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour48.9 nanograms per milliliter (ng/mL)Standard Deviation 19.8
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour105 nanograms per milliliter (ng/mL)Standard Deviation 14.3
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour120 nanograms per milliliter (ng/mL)Standard Deviation 22
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours27.7 nanograms per milliliter (ng/mL)Standard Deviation 6.94
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour2.03 nanograms per milliliter (ng/mL)Standard Deviation 0.979
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours28.4 nanograms per milliliter (ng/mL)Standard Deviation 1.42
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours94.9 nanograms per milliliter (ng/mL)Standard Deviation 19.7
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours92.6 nanograms per milliliter (ng/mL)Standard Deviation 16.1
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour100 nanograms per milliliter (ng/mL)Standard Deviation 20
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours29.8 nanograms per milliliter (ng/mL)Standard Deviation 2.81
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour113 nanograms per milliliter (ng/mL)Standard Deviation 16.8
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours54.9 nanograms per milliliter (ng/mL)Standard Deviation 6.38
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours65.1 nanograms per milliliter (ng/mL)Standard Deviation 0.651
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour120 nanograms per milliliter (ng/mL)Standard Deviation 6.24
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour117 nanograms per milliliter (ng/mL)Standard Deviation 17.2
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours24.3 nanograms per milliliter (ng/mL)Standard Deviation 3.79
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour118 nanograms per milliliter (ng/mL)Standard Deviation 2.15
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours57.6 nanograms per milliliter (ng/mL)Standard Deviation 10.5
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour86.3 nanograms per milliliter (ng/mL)Standard Deviation 15
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours3.16 nanograms per milliliter (ng/mL)Standard Deviation 1.58
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour1.45 nanograms per milliliter (ng/mL)Standard Deviation 0.417
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours4.98 nanograms per milliliter (ng/mL)Standard Deviation 1.92
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours20.2 nanograms per milliliter (ng/mL)Standard Deviation 18.7
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours4.49 nanograms per milliliter (ng/mL)Standard Deviation 2.06
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours63.8 nanograms per milliliter (ng/mL)Standard Deviation 12.3
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours24.0 nanograms per milliliter (ng/mL)Standard Deviation 11.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour90.9 nanograms per milliliter (ng/mL)Standard Deviation 24.6
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour102 nanograms per milliliter (ng/mL)Standard Deviation 29.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours13.8 nanograms per milliliter (ng/mL)Standard Deviation 43
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours71.1 nanograms per milliliter (ng/mL)Standard Deviation 23.8
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour100 nanograms per milliliter (ng/mL)Standard Deviation 28.8
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours32.4 nanograms per milliliter (ng/mL)Standard Deviation 13.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours30.2 nanograms per milliliter (ng/mL)Standard Deviation 8.92
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours8.60 nanograms per milliliter (ng/mL)Standard Deviation 5.71
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours59.9 nanograms per milliliter (ng/mL)Standard Deviation 19.7
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour2.17 nanograms per milliliter (ng/mL)Standard Deviation 1.46
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours84.4 nanograms per milliliter (ng/mL)Standard Deviation 24.6
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours59.7 nanograms per milliliter (ng/mL)Standard Deviation 15.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.610 nanograms per milliliter (ng/mL)Standard Deviation 0.00778
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours93.5 nanograms per milliliter (ng/mL)Standard Deviation 30.7
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.372 nanograms per milliliter (ng/mL)Standard Deviation 1.36
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour2.67 nanograms per milliliter (ng/mL)Standard Deviation 2.06
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours2.98 nanograms per milliliter (ng/mL)Standard Deviation 1.51
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours54.7 nanograms per milliliter (ng/mL)Standard Deviation 16.7
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour121 nanograms per milliliter (ng/mL)Standard Deviation 32.2
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0.5 hour137 nanograms per milliliter (ng/mL)Standard Deviation 47.3
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour114 nanograms per milliliter (ng/mL)Standard Deviation 29.2
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours30.8 nanograms per milliliter (ng/mL)Standard Deviation 12.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour131 nanograms per milliliter (ng/mL)Standard Deviation 52.7
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 240 hours0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours9.78 nanograms per milliliter (ng/mL)Standard Deviation 5.22
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours1.17 nanograms per milliliter (ng/mL)Standard Deviation 0.409
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour111 nanograms per milliliter (ng/mL)Standard Deviation 42.4
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 4 hours58.0 nanograms per milliliter (ng/mL)Standard Deviation 8.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 24 hours3.19 nanograms per milliliter (ng/mL)Standard Deviation 1.1
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 8 hours26.4 nanograms per milliliter (ng/mL)Standard Deviation 6.55
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 8 hours8.47 nanograms per milliliter (ng/mL)Standard Deviation 3.87
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0.5 hour104 nanograms per milliliter (ng/mL)Standard Deviation 1.86
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 1 hour86.3 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 1 hour89.7 nanograms per milliliter (ng/mL)Standard Deviation 4.66
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 0 hour0.00 nanograms per milliliter (ng/mL)Standard Deviation 0
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 2 hours70.7 nanograms per milliliter (ng/mL)Standard Deviation 5.51
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 1 hour89.8 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 72 hours0.741 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 72 hours0.989 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 4 hours48.9 nanograms per milliliter (ng/mL)Standard Deviation 12.6
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 2 hours67.3 nanograms per milliliter (ng/mL)Standard Deviation 4.5
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0 hour1.86 nanograms per milliliter (ng/mL)Standard Deviation 0.354
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 8 hours7.22 nanograms per milliliter (ng/mL)Standard Deviation 0.698
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 4 hours33.4 nanograms per milliliter (ng/mL)Standard Deviation 7.99
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 8 hours18.7 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 2 hours66.5 nanograms per milliliter (ng/mL)Standard Deviation 4.01
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 0.5 hour103 nanograms per milliliter (ng/mL)
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 24 hours3.45 nanograms per milliliter (ng/mL)Standard Deviation 1.59
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 5: 0 hour1.92 nanograms per milliliter (ng/mL)Standard Deviation 0.336
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 1 Day 1: 0.5 hour89.3 nanograms per milliliter (ng/mL)Standard Deviation 2.71
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 1 hour120 nanograms per milliliter (ng/mL)Standard Deviation 5.86
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 5: 4 hours34.7 nanograms per milliliter (ng/mL)Standard Deviation 8.12
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B, and C: Serum Concentrations of Nemvaleukin AlfaCycle 2 Day 1: 2 hours89.7 nanograms per milliliter (ng/mL)Standard Deviation 5.33
Secondary

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.

ArmMeasureGroupValue (MEDIAN)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.60 hours
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.70 hours
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.63 hours
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.67 hours
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.57 hours
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.60 hours
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.63 hours
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.73 hours
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.55 hours
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.55 hours
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.53 hours
Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.54 hours
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.55 hours
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.55 hours
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.57 hours
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.68 hours
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.60 hours
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.58 hours
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.58 hours
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.57 hours
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.58 hours
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.53 hours
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.57 hours
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.53 hours
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.51 hours
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.52 hours
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.52 hours
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.53 hours
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.52 hours
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.50 hours
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.50 hours
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.51 hours
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.50 hours
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.50 hours
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.50 hours
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.50 hours
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.58 hours
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.71 hours
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.72 hours
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.75 hours
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.73 hours
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.68 hours
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.68 hours
Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg+Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.73 hours
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.55 hours
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.55 hours
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.55 hours
Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.57 hours
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.55 hours
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.53 hours
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.55 hours
Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.53 hours
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.52 hours
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.53 hours
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.50 hours
Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.55 hours
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.50 hours
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.50 hours
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.50 hours
Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.50 hours
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.56 hours
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.55 hours
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.50 hours
Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.58 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.52 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.52 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.53 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 10.52 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 50.83 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 11.00 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 2 Day 50.77 hours
Part C, Combination Therapy, Cohort 7: Nemvaleukin 6 Alfa mcg/kg + Pembrolizumab 200 mgParts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin AlfaCycle 1 Day 10.78 hours
Secondary

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.

ArmMeasureValue (MEDIAN)
Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.118.43 weeks
Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.128.86 weeks
Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.135.14 weeks
Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.1NA weeks
Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.163.14 weeks
Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.1NA weeks
Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.1NA weeks
Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.139.07 weeks
Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kgParts B, and C: Duration of Response (DOR) Based on RECIST v1.127.86 weeks
Secondary

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.

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026