FindTrial
Sign In

Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03126110
Enrollment
145
Registered
2017-04-24
Start date
2017-04-25
Completion date
2021-11-09
Last updated
2025-08-14

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

Conditions

Advanced Malignancies, Metastatic Cancer

Keywords

cervical cancer, endometrial cancer, gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ]), hepatocellular carcinoma (HCC), melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability-high (MSI-H) colorectal cancer (CRC), non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), small cell lung cancer (SCLC), renal cell carcinoma (RCC), triple-negative breast cancer (TNBC), urothelial carcinoma, glucocorticoid-induced tumor necrosis factor receptor (GITR)

Brief summary

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Interventions

DRUGINCAGN01876

In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().

DRUGNivolumab

Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.

DRUGIpilimumab

Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.

Sponsors

Incyte Biosciences International Sàrl
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

* Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Phase 1: Subjects with advanced or metastatic solid tumors. * Phase 1: Subjects who have disease progression after treatment with available therapies. * Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma. * Presence of measurable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Exclusion criteria

* Laboratory and medical history parameters not within the Protocol-defined range * Prior treatment with any tumor necrosis factor super family agonist. * Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy. * Active autoimmune disease. * Known active central nervous system metastases and/or carcinomatous meningitis. * Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. * Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).

Design outcomes

Primary

MeasureTime frameDescription
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)up to approximately 27.4 monthsAn adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Phase 2: Objective Response Rate (ORR) Per RECIST v1.1up to approximately 44.7 monthsORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Secondary

MeasureTime frameDescription
Phase 2: ORR Per mRECIST v1.1up to approximately 44.7 monthsORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
Phase 1: Duration of Response (DOR) Per RECIST v1.1up to approximately 44.7 monthsDOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 2: DOR Per RECIST v1.1up to approximately 44.7 monthsDOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 1: DOR Per mRECIST v1.1up to approximately 44.7 monthsDOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 2: DOR Per mRECIST v1.1up to approximately 44.7 monthsDOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 1: Disease Control Rate (DCR) Per RECIST v1.1up to approximately 44.7 monthsDCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 2: DCR Per RECIST v1.1up to approximately 44.7 monthsDCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 1: DCR Per mRECIST v1.1up to approximately 44.7 monthsDCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 2: DCR Per mRECIST v1.1up to approximately 44.7 monthsDCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 1: Duration of Disease Control Per RECIST v1.1up to approximately 44.7 monthsDuration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 1: ORR Per RECIST v1.1up to approximately 44.7 monthsORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Phase 1: Duration of Disease Control Per mRECIST v1.1up to approximately 44.7 monthsDuration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 2: Duration of Disease Control Per mRECIST v1.1up to approximately 44.7 monthsDuration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. \[
Phase 1: Progression-free Survival (PFS) Per RECIST v1.1up to approximately 44.7 monthsAccording to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
Phase 2: PFS Per RECIST v1.1up to approximately 44.7 monthsAccording to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
Phase 1: PFS Per mRECIST v1.1up to approximately 44.7 monthsAccording to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
Phase 2: PFS Per mRECIST v1.1up to approximately 44.7 monthsAccording to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
Phase 1: Overall Survivalup to approximately 44.7 monthsOverall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
Phase 2: Overall Survivalup to approximately 44.7 monthsOverall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
Phase 2: : Number of Participants With Any TEAEup to approximately 27.4 monthsAn AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Phase 2: Duration of Disease Control Per RECIST v1.1up to approximately 44.7 monthsDuration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 1: ORR Per Modified RECIST (mRECIST) v1.1up to approximately 44.7 monthsORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.

Countries

Australia, Belgium, Spain, United States

Participant flow

Recruitment details

Participants were enrolled at 32 study centers in Australia, Belgium, Spain, and the United States.

Participants by arm

ArmCount
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
4
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
4
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
5
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
4
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
5
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
4
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
4
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
4
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
8
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
3
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
6
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
8
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
16
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
46
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
18
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
4
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
2
Total145

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014FG015FG016
Phase 1Death22434434526000000
Phase 1Lost to Follow-up01000000100000000
Phase 1Safety follow-up no longer necessary10000000000000000
Phase 1Survival follow-up no longer necessary00100000000000000
Phase 1Withdrawal by Subject10011000210000000
Phase 2Death00000000000612251132
Phase 2Lost to Follow-up00000000000111200
Phase 2Progressive Disease00000000000001000
Phase 2Started new treatment00000000000000100
Phase 2Study terminated by the sponsor00000000000004000
Phase 2Withdrawal by Subject00000000000133210

Baseline characteristics

CharacteristicTotalPhase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mgPhase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mgPhase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mgPhase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mgPhase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mgPhase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kgPhase 1 Group D: INCAGN01876 + Nivolumab + IpilimumabPhase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Age, Continuous58.56 Years
STANDARD_DEVIATION 11.38
42.0 Years
STANDARD_DEVIATION 16.97
54.3 Years
STANDARD_DEVIATION 9.29
48.6 Years
STANDARD_DEVIATION 9.43
60.5 Years
STANDARD_DEVIATION 9.46
59.1 Years
STANDARD_DEVIATION 10.48
69.1 Years
STANDARD_DEVIATION 9.46
58.5 Years
STANDARD_DEVIATION 11.24
67.7 Years
STANDARD_DEVIATION 4.16
61.8 Years
STANDARD_DEVIATION 7.7
61.5 Years
STANDARD_DEVIATION 11.73
63.0 Years
STANDARD_DEVIATION 9.9
62.5 Years
STANDARD_DEVIATION 16.36
60.8 Years
STANDARD_DEVIATION 12.4
62.3 Years
STANDARD_DEVIATION 7.04
48.0 Years
STANDARD_DEVIATION 18.23
59.8 Years
STANDARD_DEVIATION 14.03
51.3 Years
STANDARD_DEVIATION 7.37
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants0 Participants0 Participants1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
134 Participants2 Participants4 Participants17 Participants43 Participants14 Participants8 Participants6 Participants3 Participants7 Participants4 Participants4 Participants4 Participants4 Participants4 Participants4 Participants3 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants0 Participants0 Participants0 Participants2 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
5 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants2 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
7 Participants0 Participants0 Participants1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Native Hawaiin or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Other: Captured as Other
3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other: Mexican
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Other: Zimbabwean
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White/Caucasian
128 Participants2 Participants4 Participants16 Participants45 Participants14 Participants8 Participants6 Participants3 Participants6 Participants3 Participants4 Participants3 Participants2 Participants3 Participants4 Participants3 Participants2 Participants
Sex: Female, Male
Female
68 Participants1 Participants1 Participants18 Participants8 Participants5 Participants3 Participants2 Participants1 Participants5 Participants3 Participants3 Participants3 Participants3 Participants3 Participants5 Participants2 Participants2 Participants
Sex: Female, Male
Male
77 Participants1 Participants3 Participants0 Participants38 Participants11 Participants5 Participants4 Participants2 Participants3 Participants1 Participants1 Participants1 Participants2 Participants1 Participants0 Participants2 Participants2 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
EG017
affected / at risk
deaths
Total, all-cause mortality
2 / 42 / 44 / 53 / 44 / 54 / 43 / 44 / 45 / 82 / 36 / 66 / 812 / 1625 / 4611 / 183 / 42 / 298 / 145
other
Total, other adverse events
4 / 44 / 45 / 53 / 45 / 54 / 44 / 44 / 47 / 83 / 36 / 68 / 815 / 1643 / 4618 / 184 / 42 / 2139 / 145
serious
Total, serious adverse events
2 / 42 / 43 / 52 / 42 / 51 / 42 / 42 / 43 / 81 / 32 / 63 / 811 / 1619 / 4610 / 182 / 41 / 268 / 145

Outcome results

Primary

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.

Time frame: up to approximately 27.4 months

Population: Phase 1 Full Analysis Set (FAS): all participants enrolled in Phase 1 of the study who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)4 Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)4 Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)5 Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)4 Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)5 Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)4 Participants
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)4 Participants
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)4 Participants
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)7 Participants
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)3 Participants
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)6 Participants
Primary

Phase 2: Objective Response Rate (ORR) Per RECIST v1.1

ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population: all participants enrolled in Phase 2 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Objective Response Rate (ORR) Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Objective Response Rate (ORR) Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Objective Response Rate (ORR) Per RECIST v1.123.9 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Objective Response Rate (ORR) Per RECIST v1.116.7 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Objective Response Rate (ORR) Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Objective Response Rate (ORR) Per RECIST v1.10.0 Percentage of Participants
Secondary

Phase 1: DCR Per mRECIST v1.1

DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: DCR Per mRECIST v1.125.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: DCR Per mRECIST v1.150.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: DCR Per mRECIST v1.120.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: DCR Per mRECIST v1.150.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: DCR Per mRECIST v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: DCR Per mRECIST v1.125.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: DCR Per mRECIST v1.150.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: DCR Per mRECIST v1.125.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: DCR Per mRECIST v1.150.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: DCR Per mRECIST v1.10.0 Percentage of Participants
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: DCR Per mRECIST v1.10.0 Percentage of Participants
Secondary

Phase 1: Disease Control Rate (DCR) Per RECIST v1.1

DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Disease Control Rate (DCR) Per RECIST v1.125.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Disease Control Rate (DCR) Per RECIST v1.150.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Disease Control Rate (DCR) Per RECIST v1.120.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Disease Control Rate (DCR) Per RECIST v1.150.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Disease Control Rate (DCR) Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Disease Control Rate (DCR) Per RECIST v1.125.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Disease Control Rate (DCR) Per RECIST v1.150.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Disease Control Rate (DCR) Per RECIST v1.125.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Disease Control Rate (DCR) Per RECIST v1.150.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Disease Control Rate (DCR) Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: Disease Control Rate (DCR) Per RECIST v1.10.0 Percentage of Participants
Secondary

Phase 1: DOR Per mRECIST v1.1

DOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: DOR Per mRECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: DOR Per mRECIST v1.1NA Days
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: DOR Per mRECIST v1.1876.0 Days
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: DOR Per mRECIST v1.1NA Days
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: DOR Per mRECIST v1.1NA Days
Secondary

Phase 1: Duration of Disease Control Per mRECIST v1.1

Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.

ArmMeasureValue (MEAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per mRECIST v1.176.0 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per mRECIST v1.1668.5 Days
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Duration of Disease Control Per mRECIST v1.1NA Days
Secondary

Phase 1: Duration of Disease Control Per RECIST v1.1

Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.

ArmMeasureValue (MEAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per RECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per RECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per RECIST v1.1624.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per RECIST v1.176.0 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per RECIST v1.1167.0 Days
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Duration of Disease Control Per RECIST v1.1668.5 Days
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Duration of Disease Control Per RECIST v1.1NA Days
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Duration of Disease Control Per RECIST v1.1250.5 Days
Secondary

Phase 1: Duration of Response (DOR) Per RECIST v1.1

DOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Response (DOR) Per RECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Duration of Response (DOR) Per RECIST v1.1573.0 Days
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Duration of Response (DOR) Per RECIST v1.1876.0 Days
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Duration of Response (DOR) Per RECIST v1.1NA Days
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Duration of Response (DOR) Per RECIST v1.1281.0 Days
Secondary

Phase 1: ORR Per Modified RECIST (mRECIST) v1.1

ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per Modified RECIST (mRECIST) v1.125.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per Modified RECIST (mRECIST) v1.10.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per Modified RECIST (mRECIST) v1.120.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per Modified RECIST (mRECIST) v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: ORR Per Modified RECIST (mRECIST) v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: ORR Per Modified RECIST (mRECIST) v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: ORR Per Modified RECIST (mRECIST) v1.125.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: ORR Per Modified RECIST (mRECIST) v1.125.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: ORR Per Modified RECIST (mRECIST) v1.112.5 Percentage of Participants
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: ORR Per Modified RECIST (mRECIST) v1.10.0 Percentage of Participants
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: ORR Per Modified RECIST (mRECIST) v1.10.0 Percentage of Participants
Secondary

Phase 1: ORR Per RECIST v1.1

ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Time frame: up to approximately 44.7 months

Population: Phase 1 Response Evaluable Population: all participants enrolled in Phase 1 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per RECIST v1.125.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per RECIST v1.120.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: ORR Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: ORR Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: ORR Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: ORR Per RECIST v1.125.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: ORR Per RECIST v1.125.0 Percentage of Participants
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: ORR Per RECIST v1.112.5 Percentage of Participants
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: ORR Per RECIST v1.10.0 Percentage of Participants
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: ORR Per RECIST v1.10.0 Percentage of Participants
Secondary

Phase 1: Overall Survival

Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.

Time frame: up to approximately 44.7 months

Population: Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Overall SurvivalNA Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Overall SurvivalNA Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Overall Survival253.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Overall Survival100.0 Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Overall Survival289.5 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Overall Survival266.5 Days
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Overall Survival588.0 Days
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Overall Survival200.0 Days
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Overall Survival425.0 Days
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Overall Survival627.0 Days
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: Overall Survival229.5 Days
Secondary

Phase 1: PFS Per mRECIST v1.1

According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).

Time frame: up to approximately 44.7 months

Population: Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: PFS Per mRECIST v1.166.0 Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: PFS Per mRECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: PFS Per mRECIST v1.1116.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: PFS Per mRECIST v1.188.0 Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: PFS Per mRECIST v1.157.0 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: PFS Per mRECIST v1.1NA Days
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: PFS Per mRECIST v1.198.0 Days
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: PFS Per mRECIST v1.1NA Days
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: PFS Per mRECIST v1.1134.0 Days
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: PFS Per mRECIST v1.1128.0 Days
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: PFS Per mRECIST v1.1NA Days
Secondary

Phase 1: Progression-free Survival (PFS) Per RECIST v1.1

According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.

Time frame: up to approximately 44.7 months

Population: Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Progression-free Survival (PFS) Per RECIST v1.152.5 Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Progression-free Survival (PFS) Per RECIST v1.172.0 Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Progression-free Survival (PFS) Per RECIST v1.153.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 1: Progression-free Survival (PFS) Per RECIST v1.164.0 Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Progression-free Survival (PFS) Per RECIST v1.147.5 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Progression-free Survival (PFS) Per RECIST v1.160.0 Days
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 1: Progression-free Survival (PFS) Per RECIST v1.188.5 Days
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Progression-free Survival (PFS) Per RECIST v1.141.0 Days
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Progression-free Survival (PFS) Per RECIST v1.1110.0 Days
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6WPhase 1: Progression-free Survival (PFS) Per RECIST v1.156.0 Days
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgPhase 1: Progression-free Survival (PFS) Per RECIST v1.154.5 Days
Secondary

Phase 2: DCR Per mRECIST v1.1

DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per mRECIST v1.137.5 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per mRECIST v1.156.3 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per mRECIST v1.156.5 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per mRECIST v1.155.6 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: DCR Per mRECIST v1.150.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: DCR Per mRECIST v1.150.0 Percentage of Participants
Secondary

Phase 2: DCR Per RECIST v1.1

DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per RECIST v1.137.5 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per RECIST v1.156.3 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per RECIST v1.154.3 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DCR Per RECIST v1.155.6 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: DCR Per RECIST v1.150.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: DCR Per RECIST v1.150.0 Percentage of Participants
Secondary

Phase 2: DOR Per mRECIST v1.1

DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DOR Per mRECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DOR Per mRECIST v1.1NA Days
Secondary

Phase 2: DOR Per RECIST v1.1

DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DOR Per RECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: DOR Per RECIST v1.1120.0 Days
Secondary

Phase 2: Duration of Disease Control Per mRECIST v1.1

Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. \[

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per mRECIST v1.1218.0 Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per mRECIST v1.1168.0 Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per mRECIST v1.1NA Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per mRECIST v1.1NA Days
Secondary

Phase 2: Duration of Disease Control Per RECIST v1.1

Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per RECIST v1.1218.0 Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per RECIST v1.1109.0 Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per RECIST v1.1253.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per RECIST v1.1168.0 Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per RECIST v1.1206.5 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Duration of Disease Control Per RECIST v1.1109.0 Days
Secondary

Phase 2: : Number of Participants With Any TEAE

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.

Time frame: up to approximately 27.4 months

Population: Phase 2 FAS

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: : Number of Participants With Any TEAE8. Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: : Number of Participants With Any TEAE16 Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: : Number of Participants With Any TEAE45 Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: : Number of Participants With Any TEAE18 Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: : Number of Participants With Any TEAE4 Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: : Number of Participants With Any TEAE2 Participants
Secondary

Phase 2: ORR Per mRECIST v1.1

ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.

Time frame: up to approximately 44.7 months

Population: Phase 2 Response Evaluable Population

ArmMeasureValue (NUMBER)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: ORR Per mRECIST v1.10.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: ORR Per mRECIST v1.10.0 Percentage of Participants
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: ORR Per mRECIST v1.126.1 Percentage of Participants
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: ORR Per mRECIST v1.116.7 Percentage of Participants
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: ORR Per mRECIST v1.10.0 Percentage of Participants
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: ORR Per mRECIST v1.10.0 Percentage of Participants
Secondary

Phase 2: Overall Survival

Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.

Time frame: up to approximately 44.7 months

Population: Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Overall Survival290.5 Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Overall Survival179.0 Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Overall Survival491.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: Overall Survival492.0 Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Overall Survival485.0 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: Overall Survival264.0 Days
Secondary

Phase 2: PFS Per mRECIST v1.1

According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).

Time frame: up to approximately 44.7 months

Population: Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per mRECIST v1.185.0 Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per mRECIST v1.1105.0 Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per mRECIST v1.1235.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per mRECIST v1.1168.0 Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: PFS Per mRECIST v1.1118.0 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: PFS Per mRECIST v1.1NA Days
Secondary

Phase 2: PFS Per RECIST v1.1

According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.

Time frame: up to approximately 44.7 months

Population: Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

ArmMeasureValue (MEDIAN)
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per RECIST v1.157.0 Days
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per RECIST v1.175.0 Days
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per RECIST v1.1115.0 Days
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2WPhase 2: PFS Per RECIST v1.1102.0 Days
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: PFS Per RECIST v1.187.0 Days
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2WPhase 2: PFS Per RECIST v1.164.5 Days

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026