A Phase 1/2 interventional study of INCAGN01876 and Nivolumab in Advanced Malignancies and Metastatic Cancer, sponsored by Incyte Biosciences International Sàrl. Completed at 38 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Incyte Biosciences International Sàrl (part of Incyte Corporation) · Phase 1/2, Interventional, and Treatment
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 145 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Incyte Biosciences International Sàrl is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
First submitted after Incyte Biosciences International Sàrl became part of Incyte Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: INCAGN01876 · Drug: Nivolumab
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876 · Drug: Nivolumab
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876 · Drug: Nivolumab
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876 · Drug: Nivolumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Drug: INCAGN01876 · Drug: Nivolumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Drug: INCAGN01876 · Drug: Nivolumab
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 5.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Drug: INCAGN01876 · Drug: Nivolumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
Drug: INCAGN01876 · Drug: Ipilimumab
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Drug: INCAGN01876 · Drug: Ipilimumab
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Drug: INCAGN01876 · Drug: 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.
Drug: INCAGN01876 · Drug: Nivolumab · Drug: Ipilimumab
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Drug: INCAGN01876 · Drug: Ipilimumab
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876 · Drug: Nivolumab
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.
Drug: INCAGN01876 · Drug: Nivolumab
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876 · Drug: Nivolumab
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876 · Drug: Nivolumab
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.
Drug: INCAGN01876 · Drug: Nivolumab
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 ().
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Participants were enrolled at 32 study centers in Australia, Belgium, Spain, and the United States.
| Milestone | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 4 | 5 | 4 | 5 | 4 | 4 | 4 | 8 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 3 | 5 | 4 | 5 | 4 | 3 | 4 | 8 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 2 | 2 | 4 | 3 | 4 | 4 | 3 | 4 | 5 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Safety follow-up no longer necessary | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Survival follow-up no longer necessary | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 16 | 46 | 18 | 4 | 2 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 2 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 16 | 34 | 16 | 4 | 2 |
| Withdrew: Study terminated by the sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 3 | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 12 | 25 | 11 | 3 | 2 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Started new treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
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.
| Participants | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 4 | 4 | 5 | 4 | 5 | 4 | 4 | 4 | 7 | 3 | 6 |
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.
| Percentage of Participants | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: Objective Response Rate (ORR) Per RECIST v1.1 | 0.0 | 0.0 | 23.9 | 16.7 | 0.0 | 0.0 |
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.
| Percentage of Participants | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: ORR Per RECIST v1.1 | 25.0 | 0.0 | 20.0 | 0.0 | 0.0 | 0.0 | 25.0 | 25.0 | 12.5 | 0.0 | 0.0 |
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.
| Percentage of Participants | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: ORR Per Modified RECIST (mRECIST) v1.1 | 25.0 | 0.0 | 20.0 | 0.0 | 0.0 | 0.0 | 25.0 | 25.0 | 12.5 | 0.0 | 0.0 |
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.
| Percentage of Participants | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: ORR Per mRECIST v1.1 | 0.0 | 0.0 | 26.1 | 16.7 | 0.0 | 0.0 |
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.
| Days | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Duration of Response (DOR) Per RECIST v1.1 | NA (NA to NA) | — | 573.0 (NA to NA) | — | — | — | 876.0 (NA to NA) | NA (NA to NA) | 281.0 (NA to NA) | — | — |
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.
| Days | Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: DOR Per RECIST v1.1 | — | — | NA (118.0 to NA) | 120.0 (113.0 to NA) | — | — |
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.
| Days | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: DOR Per mRECIST v1.1 | NA (NA to NA) | — | NA (NA to NA) | — | — | — | 876.0 (NA to NA) | NA (NA to NA) | NA (NA to NA) | — | — |
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.
| Days | Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: DOR Per mRECIST v1.1 | — | — | NA (NA to NA) | NA (113.0 to NA) | — | — |
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.
| Percentage of Participants | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Disease Control Rate (DCR) Per RECIST v1.1 | 25.0 | 50.0 | 20.0 | 50.0 | 0.0 | 25.0 | 50.0 | 25.0 | 50.0 | 0.0 | 0.0 |
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.
| Percentage of Participants | Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: DCR Per RECIST v1.1 | 37.5 | 56.3 | 54.3 | 55.6 | 50.0 | 50.0 |
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.
| Percentage of Participants | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: DCR Per mRECIST v1.1 | 25.0 | 50.0 | 20.0 | 50.0 | 0.0 | 25.0 | 50.0 | 25.0 | 50.0 | 0.0 | 0.0 |
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.
| Percentage of Participants | Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: DCR Per mRECIST v1.1 | 37.5 | 56.3 | 56.5 | 55.6 | 50.0 | 50.0 |
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.
| Days | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Duration of Disease Control Per RECIST v1.1 | NA (NA to NA) | NA (89.0 to NA) | 624.0 (NA to NA) | 76.0 (NA to NA) | — | 167.0 (NA to NA) | 668.5 (125.0 to NA) | NA (NA to NA) | 250.5 (110.0 to NA) | — | — |
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.
| Days | Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: Duration of Disease Control Per RECIST v1.1 | 218.0 (106.0 to NA) | 109.0 (63.0 to NA) | 253.0 (156.0 to NA) | 168.0 (71.0 to NA) | 206.5 (118.0 to NA) | 109.0 (NA to NA) |
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.
| Days | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Duration of Disease Control Per mRECIST v1.1 | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 76.0 (NA to NA) | — | NA (NA to NA) | 668.5 (125.0 to NA) | NA (NA to NA) | NA (134.0 to NA) | — | — |
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. \[
| Days | Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: Duration of Disease Control Per mRECIST v1.1 | 218.0 (133.0 to NA) | 168.0 (63.0 to NA) | NA (202.0 to NA) | NA (137.0 to NA) | NA (118.0 to NA) | NA (NA to NA) |
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.
| Days | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Progression-free Survival (PFS) Per RECIST v1.1 | 52.5 (48.0 to NA) | 72.0 (53.0 to NA) | 53.0 (9.0 to NA) | 64.0 (48.0 to NA) | 47.5 (29.0 to NA) | 60.0 (50.0 to NA) | 88.5 (44.0 to NA) | 41.0 (15.0 to NA) | 110.0 (53.0 to 276.0) | 56.0 (53.0 to NA) | 54.5 (21.0 to NA) |
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.
| Days | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: PFS Per RECIST v1.1 | 57.0 (20.0 to 218.0) | 75.0 (45.0 to 120.0) | 115.0 (59.0 to 174.0) | 102.0 (51.0 to 225.0) | 87.0 (52.0 to NA) | 64.5 (20.0 to NA) |
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).
| Days | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: PFS Per mRECIST v1.1 | 66.0 (48.0 to NA) | NA (55.0 to NA) | 116.0 (64.0 to NA) | 88.0 (76.0 to NA) | 57.0 (29.0 to NA) | NA (100.0 to NA) | 98.0 (52.0 to NA) | NA (97.0 to NA) | 134.0 (53.0 to NA) | 128.0 (56.0 to NA) | NA (46.0 to NA) |
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).
| Days | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: PFS Per mRECIST v1.1 | 85.0 (20.0 to 218.0) | 105.0 (63.0 to NA) | 235.0 (129.0 to NA) | 168.0 (51.0 to NA) | 118.0 (52.0 to NA) | NA (20.0 to NA) |
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
| Days | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Overall Survival | NA (76.0 to NA) | NA (55.0 to NA) | 253.0 (77.0 to NA) | 100.0 (76.0 to NA) | 289.5 (170.0 to NA) | 266.5 (100.0 to NA) | 588.0 (424.0 to NA) | 200.0 (97.0 to NA) | 425.0 (110.0 to NA) | 627.0 (128.0 to NA) | 229.5 (46.0 to NA) |
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
| Days | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: Overall Survival | 290.5 (20.0 to NA) | 179.0 (75.0 to 404.0) | 491.0 (344.0 to NA) | 492.0 (92.0 to 733.0) | 485.0 (52.0 to NA) | 264.0 (20.0 to NA) |
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.
| Participants | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|
| Phase 2: : Number of Participants With Any TEAE | 8. | 16 | 45 | 18 | 4 | 2 |
Collected over up to approximately 27.4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 2/4 (50%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 2/4 (50%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4/5 (80%) | 3/5 (60%) | 5/5 (100%) |
| Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 3/4 (75%) | 2/4 (50%) | 3/4 (75%) |
| Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4/5 (80%) | 2/5 (40%) | 5/5 (100%) |
| Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4/4 (100%) | 1/4 (25%) | 4/4 (100%) |
| Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 3/4 (75%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 4/4 (100%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 5/8 (62.5%) | 3/8 (37.5%) | 7/8 (87.5%) |
| Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | 6/6 (100%) | 2/6 (33.3%) | 6/6 (100%) |
| Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | 6/8 (75%) | 3/8 (37.5%) | 8/8 (100%) |
| Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | 12/16 (75%) | 11/16 (68.8%) | 15/16 (93.8%) |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | 25/46 (54.3%) | 19/46 (41.3%) | 43/46 (93.5%) |
| Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | 11/18 (61.1%) | 10/18 (55.6%) | 18/18 (100%) |
| Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | 3/4 (75%) | 2/4 (50%) | 4/4 (100%) |
| Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| Total | 98/145 (67.6%) | 68/145 (46.9%) | 139/145 (95.9%) |
| Event | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HypercalcaemiaMetabolism and nutrition disorders | 0/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 0/4 | 1/2 | 1/145 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/4 | 0/4 | 2/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 0/4 | 0/2 | 2/145 |
| AnaemiaBlood and lymphatic system disorders | 0/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 1/4 | 0/4 | 0/8 | 1/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 0/4 | 0/2 | 2/145 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 1/3 | 0/6 | 0/8 | 1/16 | 0/46 | 0/18 | 0/4 | 0/2 | 2/145 |
| Abdominal painGastrointestinal disorders | 1/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 2/16 | 0/46 | 1/18 | 0/4 | 0/2 | 4/145 |
| Acute myocardial infarctionCardiac disorders | 0/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 1/46 | 0/18 | 1/4 | 0/2 | 2/145 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/4 | 1/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 0/4 | 0/2 | 1/145 |
| AscitesGastrointestinal disorders | 1/4 | 0/4 | 0/5 | 0/4 | 0/5 | 1/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 0/4 | 0/2 | 2/145 |
| Atrial fibrillationCardiac disorders | 0/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 1/4 | 0/2 | 1/145 |
| Cholecystitis acuteHepatobiliary disorders | 0/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 1/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 0/4 | 0/2 | 1/145 |
| Event | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/4 | 0/4 | 1/5 | 0/4 | 1/5 | 0/4 | 0/4 | 2/4 | 4/8 | 2/3 | 0/6 | 3/8 | 6/16 | 7/46 | 5/18 | 1/4 | 2/2 | 35/145 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/4 | 0/4 | 2/5 | 0/4 | 0/5 | 0/4 | 3/4 | 0/4 | 1/8 | 0/3 | 1/6 | 0/8 | 3/16 | 7/46 | 1/18 | 2/4 | 0/2 | 21/145 |
| FatigueGeneral disorders | 1/4 | 0/4 | 2/5 | 0/4 | 0/5 | 2/4 | 1/4 | 0/4 | 0/8 | 1/3 | 1/6 | 6/8 | 5/16 | 15/46 | 5/18 | 1/4 | 0/2 | 40/145 |
| PruritusSkin and subcutaneous tissue disorders | 0/4 | 1/4 | 2/5 | 0/4 | 3/5 | 0/4 | 0/4 | 1/4 | 3/8 | 1/3 | 1/6 | 3/8 | 3/16 | 9/46 | 7/18 | 2/4 | 0/2 | 36/145 |
| RashSkin and subcutaneous tissue disorders | 0/4 | 0/4 | 1/5 | 0/4 | 3/5 | 1/4 | 1/4 | 1/4 | 2/8 | 0/3 | 1/6 | 2/8 | 3/16 | 6/46 | 1/18 | 0/4 | 0/2 | 22/145 |
| Abdominal distensionGastrointestinal disorders | 1/4 | 2/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 1/8 | 1/16 | 0/46 | 0/18 | 0/4 | 0/2 | 5/145 |
| AnaemiaBlood and lymphatic system disorders | 1/4 | 1/4 | 1/5 | 0/4 | 1/5 | 0/4 | 0/4 | 1/4 | 1/8 | 1/3 | 3/6 | 0/8 | 3/16 | 7/46 | 5/18 | 0/4 | 0/2 | 25/145 |
| AscitesGastrointestinal disorders | 0/4 | 1/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 2/4 | 0/8 | 0/3 | 0/6 | 1/8 | 4/16 | 0/46 | 1/18 | 0/4 | 0/2 | 9/145 |
| Aspartate aminotransferase increasedInvestigations | 1/4 | 2/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 1/6 | 0/8 | 0/16 | 2/46 | 0/18 | 1/4 | 0/2 | 7/145 |
| AtelectasisRespiratory, thoracic and mediastinal disorders | 0/4 | 0/4 | 0/5 | 0/4 | 0/5 | 0/4 | 0/4 | 0/4 | 0/8 | 0/3 | 0/6 | 0/8 | 0/16 | 0/46 | 0/18 | 0/4 | 1/2 | 1/145 |
The full analysis set (FAS) included all participants enrolled in the study who received at least 1 dose of study drug.
| Age, Continuous(Years) | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 51.3 ± 7.37 | 59.8 ± 14.03 | 48.0 ± 18.23 | 62.3 ± 7.04 | 60.8 ± 12.40 | 62.5 ± 16.36 | 63.0 ± 9.90 | 61.5 ± 11.73 | 61.8 ± 7.70 | 67.7 ± 4.16 | 58.5 ± 11.24 | 69.1 ± 9.46 | 59.1 ± 10.48 | 60.5 ± 9.46 | 48.6 ± 9.43 | 54.3 ± 9.29 | 42.0 ± 16.97 | 58.56 ± 11.38 |
| Sex: Female, Male(Participants) | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 2 | 5 | 3 | 3 | 3 | 3 | 3 | 5 | 1 | 2 | 3 | 5 | 8 | 18 | 1 | 1 | 68 |
| Male | 2 | 2 | 0 | 1 | 2 | 1 | 1 | 1 | 3 | 2 | 4 | 5 | 11 | 38 | 0 | 3 | 1 | 77 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 8 |
| Not Hispanic or Latino | 3 | 3 | 4 | 4 | 4 | 4 | 4 | 4 | 7 | 3 | 6 | 8 | 14 | 43 | 17 | 4 | 2 | 134 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 3 |
| Race/Ethnicity, Customized(Participants) | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| White/Caucasian | 2 | 3 | 4 | 3 | 2 | 3 | 4 | 3 | 6 | 3 | 6 | 8 | 14 | 45 | 16 | 4 | 2 | 128 |
| Black or African American | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 7 |
| Asian | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 5 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiin or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Other: Captured as "Other" | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Other: Zimbabwean | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Other: Mexican | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2017 to primary completion in Nov 2021, 54 months.
Results were first posted in Dec 2022, 1 year 1 month after primary completion.
Of 127 industry-sponsored phase 1/2 interventional studies under Neoplasm Metastasis, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 89. This study's 54 months is close to that.
Counting every sponsor, half of 213 studies reached it within 62 months; a quarter within 41 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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