A Phase 1/2 interventional study of INCAGN01949 and Nivolumab in Advanced Malignancies, sponsored by Incyte Biosciences International Sàrl. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-27.
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 INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 52 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms 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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
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.
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.
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.
INCAGN01949 (70, 200, 350, or 700 milligrams \[mg\]) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors
Drug: INCAGN01949 · Drug: Nivolumab
INCAGN01949 (70, 200, 350, or 700 mg) combined with ipilimumab 1 mg/kilogram (kg) in participants with advanced or metastatic select solid tumors
Drug: INCAGN01949 · Drug: Ipilimumab
INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors
Drug: INCAGN01949 · Drug: Nivolumab · Drug: Ipilimumab
Run-in with INCAGN01949 (70, 200, or 350 mg) x 2 doses, followed by INCAGN01949 (70, 200, or 350 mg) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors
Drug: INCAGN01949 · Drug: Nivolumab
Run-in with INCAGN01949 x 2 doses, followed by INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors
Drug: INCAGN01949 · Drug: Nivolumab · Drug: Ipilimumab
INCAGN01949 combined with nivolumab in programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC)
Drug: INCAGN01949 · Drug: Nivolumab
INCAGN01949 alone, combined with nivolumab, and combined with nivolumab and ipilimumab in PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC
Drug: INCAGN01949 · Drug: Nivolumab · Drug: Ipilimumab
In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV 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 Treatment-emergent Adverse Events (TEAEs)
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 that occurred 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 adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Time frame: up to 17.4 months
Phase 1: Number of Participants With a Grade 3 or Higher 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. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.
Time frame: up to 17.4 months
Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of progressive disease (PD). 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 24 months
Phase 1: ORR
ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, per RECIST v1.1, as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of PD. 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 15.6 months
Phase 1: Duration of Response (DOR)
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 first assessment of PD, 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.
Time frame: up to 11.0 months
Phase 2: DOR
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 first assessment of PD, 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.
Time frame: up to 24 months
Phase 1: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), 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. SD: no change in target lesions to qualify for CR, PR, or PD.
Time frame: up to 15.6 months
Phase 2: DCR
DCR was defined as the percentage of participants with a CR, PR, or SD, 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. SD: no change in target lesions to qualify for CR, PR, or PD.
Time frame: up to 24 months
Phase 1: Duration of Disease Control
Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, 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. SD: no change in target lesions to qualify for CR, PR, or PD. PD: progression of a target or non-target lesion or presence of a new lesion.
Time frame: up to 15.4 months
Phase 2: Duration of Disease Control
Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, 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. SD: no change in target lesions to qualify for CR, PR, or PD. PD: progression of a target or non-target lesion or presence of a new lesion.
Time frame: up to 24 months
Phase 1: Progression-free Survival (PFS)
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 per RECIST v1.1.
Time frame: up to 15.6 months
Phase 2: PFS
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 per RECIST v1.1.
Time frame: up to 24 months
Phase 2: Number of Participants With TEAEs
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 that occurred 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 adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Time frame: up to 24 months
Phase 2: Number of Participants With a Grade 3 or Higher 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. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using CTCAE v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.
Time frame: up to 24 months
This study was conducted at 13 study centers in the United States in two parts: dose escalation (Part 1) and safety expansion (Part 2).
| Milestone | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | Phase 2, Part A: INCAGN01949 + Nivolumab | Phase 2, Part B: INCAGN01949; INCAGN01949 + Nivolumab; INCAGN01949 + Nivolumab + Ipilimumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 4 | 5 | 5 | 4 | 5 | 4 | 3 | 0 | 6 | 6 | 6 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 4 | 5 | 5 | 4 | 5 | 4 | 3 | 0 | 6 | 6 | 6 | 0 | 0 | 0 |
| Withdrew: Death | 3 | 2 | 4 | 4 | 2 | 2 | 3 | 1 | 0 | 5 | 4 | 3 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Survival follow-up no longer required per protocol amendment | 1 | 2 | 0 | 1 | 1 | 2 | 1 | 2 | 0 | 0 | 2 | 3 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 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 that occurred 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 adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
| Participants | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 4 | 4 | 5 | 5 | 4 | 5 | 4 | 3 | 6 | 6 | 6 |
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. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.
| Participants | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Number of Participants With a Grade 3 or Higher TEAE | 2 | 1 | 3 | 3 | 2 | 2 | 3 | 1 | 5 | 4 | 3 |
ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of progressive disease (PD). 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.
No measurements were reported for this outcome.
ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, per RECIST v1.1, as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of PD. 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, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: ORR | 25.0 | 25.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 16.7 | 0.0 |
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 first assessment of PD, 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.
| days | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Duration of Response (DOR) | 97.0 (NA to NA) | NA (NA to NA) | — | — | — | — | — | — | — | 86.0 (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 first assessment of PD, 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.
No measurements were reported for this outcome.
DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), 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. SD: no change in target lesions to qualify for CR, PR, or PD.
| percentage of participants | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Disease Control Rate (DCR) | 25.0 | 25.0 | 40.0 | 0.0 | 75.0 | 0.0 | 50.0 | 33.3 | 33.3 | 33.3 | 66.7 |
DCR was defined as the percentage of participants with a CR, PR, or SD, 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. SD: no change in target lesions to qualify for CR, PR, or PD.
No measurements were reported for this outcome.
Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, 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. SD: no change in target lesions to qualify for CR, PR, or PD. PD: progression of a target or non-target lesion or presence of a new lesion.
| days | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Duration of Disease Control | 97.0 (NA to NA) | NA (NA to NA) | 120.0 (61.0 to 179.0) | — | 58.0 (43.0 to 113.0) | — | 298.5 (169.0 to 428.0) | 100.0 (NA to NA) | 252.0 (NA to NA) | 117.0 (86.0 to 148.0) | 115.0 (52.0 to 418.0) |
Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, 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. SD: no change in target lesions to qualify for CR, PR, or PD. PD: progression of a target or non-target lesion or presence of a new lesion.
No measurements were reported for this outcome.
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 per RECIST v1.1.
| days | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Progression-free Survival (PFS) | 1.8 (1.0 to 4.9) | 1.8 (1.4 to NA) | 2.7 (1.4 to 7.5) | 1.8 (0.8 to 2.1) | 3.5 (0.7 to 5.4) | 1.6 (1.2 to 1.8) | 4.6 (1.2 to 15.7) | 1.8 (1.7 to 5.1) | 1.6 (0.1 to 9.9) | 2.2 (1.8 to 6.7) | 4.6 (1.8 to 15.5) |
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 per RECIST v1.1.
No measurements were reported for this outcome.
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 that occurred 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 adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
No measurements were reported for this outcome.
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. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using CTCAE v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.
No measurements were reported for this outcome.
Collected over up to 17.4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | 3/4 (75%) | 3/4 (75%) | 4/4 (100%) |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | 2/4 (50%) | 1/4 (25%) | 4/4 (100%) |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 4/5 (80%) | 4/5 (80%) | 5/5 (100%) |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | 4/5 (80%) | 3/5 (60%) | 5/5 (100%) |
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | 2/4 (50%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | 2/5 (40%) | 2/5 (40%) | 5/5 (100%) |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | 3/4 (75%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | 1/3 (33.3%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | 5/6 (83.3%) | 4/6 (66.7%) | 6/6 (100%) |
| Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | 4/6 (66.7%) | 3/6 (50%) | 6/6 (100%) |
| Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | 3/6 (50%) | 3/6 (50%) | 6/6 (100%) |
| Total | 33/52 (63.5%) | 28/52 (53.8%) | 52/52 (100%) |
| Event | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/4 | 0/4 | 1/5 | 1/5 | 1/4 | 0/5 | 2/4 | 1/3 | 2/6 | 0/6 | 2/6 | 11/52 |
| Small intestinal obstructionGastrointestinal disorders | 0/4 | 0/4 | 0/5 | 1/5 | 0/4 | 0/5 | 0/4 | 0/3 | 2/6 | 1/6 | 0/6 | 4/52 |
| Adrenal insufficiencyEndocrine disorders | 0/4 | 1/4 | 0/5 | 0/5 | 0/4 | 0/5 | 0/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| ConstipationGastrointestinal disorders | 1/4 | 0/4 | 0/5 | 0/5 | 0/4 | 0/5 | 0/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| DehydrationMetabolism and nutrition disorders | 1/4 | 0/4 | 0/5 | 0/5 | 0/4 | 0/5 | 0/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/4 | 0/4 | 0/5 | 0/5 | 0/4 | 0/5 | 1/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| FatigueGeneral disorders | 0/4 | 1/4 | 0/5 | 0/5 | 0/4 | 0/5 | 0/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| HaematemesisGastrointestinal disorders | 1/4 | 0/4 | 0/5 | 0/5 | 0/4 | 0/5 | 0/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| HyponatraemiaMetabolism and nutrition disorders | 0/4 | 1/4 | 0/5 | 0/5 | 0/4 | 0/5 | 0/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| Ischaemic strokeNervous system disorders | 0/4 | 0/4 | 0/5 | 0/5 | 0/4 | 0/5 | 1/4 | 0/3 | 0/6 | 0/6 | 0/6 | 1/52 |
| Event | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FatigueGeneral disorders | 4/4 | 2/4 | 2/5 | 2/5 | 2/4 | 2/5 | 3/4 | 1/3 | 3/6 | 3/6 | 3/6 | 27/52 |
| HypertensionVascular disorders | 0/4 | 0/4 | 1/5 | 0/5 | 0/4 | 0/5 | 1/4 | 3/3 | 0/6 | 1/6 | 1/6 | 7/52 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/4 | 3/4 | 2/5 | 0/5 | 0/4 | 1/5 | 2/4 | 0/3 | 2/6 | 2/6 | 0/6 | 14/52 |
| NauseaGastrointestinal disorders | 2/4 | 2/4 | 0/5 | 1/5 | 1/4 | 0/5 | 3/4 | 1/3 | 3/6 | 3/6 | 3/6 | 19/52 |
| Tumour flareNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/4 | 0/4 | 0/5 | 0/5 | 2/4 | 0/5 | 0/4 | 0/3 | 0/6 | 0/6 | 0/6 | 5/52 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/4 | 0/4 | 1/5 | 0/5 | 0/4 | 1/5 | 1/4 | 2/3 | 0/6 | 1/6 | 0/6 | 6/52 |
| Non-cardiac chest painGeneral disorders | 0/4 | 0/4 | 0/5 | 0/5 | 0/4 | 0/5 | 0/4 | 2/3 | 0/6 | 0/6 | 1/6 | 3/52 |
| Decreased appetiteMetabolism and nutrition disorders | 0/4 | 1/4 | 3/5 | 1/5 | 1/4 | 0/5 | 0/4 | 0/3 | 1/6 | 0/6 | 2/6 | 9/52 |
| Lipase increasedInvestigations | 0/4 | 0/4 | 0/5 | 0/5 | 0/4 | 3/5 | 0/4 | 0/3 | 1/6 | 2/6 | 1/6 | 7/52 |
| Abdominal painGastrointestinal disorders | 1/4 | 2/4 | 1/5 | 1/5 | 1/4 | 0/5 | 0/4 | 1/3 | 1/6 | 1/6 | 1/6 | 10/52 |
| Age, Continuous(years) | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 45.0 ± 7.53 | 58.0 ± 3.16 | 60.0 ± 5.00 | 67.8 ± 8.07 | 58.5 ± 6.45 | 60.6 ± 10.21 | 59.3 ± 12.71 | 50.0 ± 20.52 | 60.5 ± 8.73 | 55.7 ± 15.96 | 64.0 ± 13.96 | 58.77 ± 11.48 |
| Sex: Female, Male(Participants) | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 3 | 1 | 2 | 2 | 1 | 2 | 3 | 1 | 6 | 3 | 2 | 26 |
| Male | 1 | 3 | 3 | 3 | 3 | 3 | 1 | 2 | 0 | 3 | 4 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
| Not Hispanic or Latino | 4 | 4 | 4 | 4 | 3 | 4 | 4 | 3 | 6 | 6 | 6 | 48 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 1 | 0 | 1 | 6 |
| White | 4 | 4 | 4 | 5 | 3 | 3 | 2 | 3 | 5 | 6 | 5 | 44 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
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