Advanced MalignanciesPhase 1/2NCT03126110
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
A Phase 1/2 study testing INCAGN01876, Nivolumab and Ipilimumab in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 38 sites in 4 countries.
Trial summary
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Metastatic Cancer
- What is being tested?
- INCAGN01876, Nivolumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 38 sitesin 4 countries
- Study dates
- 25 Apr 2017to 9 Nov 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
- Presence of measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Who cannot join
- Laboratory and medical history parameters not within the Protocol-defined range
- Prior treatment with any tumor necrosis factor super family agonist.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- Active autoimmune disease.
- Known active central nervous system metastases and/or carcinomatous meningitis.
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- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
Trial locations and contacts
38 sites in 4 countries.
38 sites in 4 countries
United States15 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
BUMC Mary Crowley Cancer Research Centers
Dallas, Texas, 75230
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Florida
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson
Houston, Texas, 77030
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Tennessee Oncology, Sarah Cannon Research Institute
Nashville, Tennessee, 37201
Memorial Sloan Kettering Cancer
New York, New York, 10065
University of Oklahoma, Sarah Cannon Research Institute
Oklahoma City, Oklahoma, 73104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh, UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, 15232
Providance Portland Medical Center
Portland, Oregon, 97213
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University - Siteman Cancer Center
St Louis, Missouri, 37201
Spain10 sites
Hospital Clinic I Provincial
Barcelona, 08036
Hospital Clinico y Provincial de Barcelona
Barcelona, 08036
Institut Catala D'Oncologia-Badalona
Barcelona, 08916
Hospital Vall de Hebron
Barcelona
Hospital Reina Sophia
Córdoba, 14004
University Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario Doce de Octubre
Madrid, 28041
Hospital HM Sanchinarro
Madrid, 28050
Clinica Universidad De Navarra (CUN)
Pamplona, 31008
Hospital Universitario Virgen Del Rocio
Seville, 41015
Belgium8 sites
Saint Augustinus Hospital
Antwerp, 2610
Institut Jules Bordet
Brussels, 1000
CHU Brugmann
Brussels, 1020
Cliniques Universitaires Saint-Luc
Brussels, 1200
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Charleroi, 6000
Ghent University Hospital
Ghent, 37201
AZ Groeninge
Kortrijk, 8500
CHA Centre Hospitalier de l'Ardenne
Libramont, Chevigny, 6800
Australia5 sites
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148
Greenslopes Private Hospital
Brisbane, Queensland, 4120
Austin Hospital
Heidelberg, Victoria, 3084
Linear Clinical Research
Perth, Western Australia, 6009
Scientia Clinical Research
Randwick, New South Wales, 2148
About this study
Official title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
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.
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Being tested
- INCAGN01876, Nivolumab, Ipilimumab
- Keywords
- cervical cancer, endometrial cancer, gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ]), hepatocellular carcinoma (HCC), melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability-high (MSI-H) colorectal cancer (CRC), non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), small cell lung cancer (SCLC), renal cell carcinoma (RCC), triple-negative breast cancer (TNBC), urothelial carcinoma, glucocorticoid-induced tumor necrosis factor receptor (GITR)
- Medical subject headings
- Neoplasm Metastasis, Uterine Cervical Neoplasms, Endometrial Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Melanoma, Carcinoma, Merkel Cell, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCAGN01876Drug
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 ().
NivolumabDrug
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
IpilimumabDrug
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W | Experimental | Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W). Receives: Drug: INCAGN01876; Drug: Ipilimumab |
| Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W | Experimental | Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W. Receives: Drug: INCAGN01876; Drug: Ipilimumab |
| Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W | Experimental | Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W. Receives: Drug: INCAGN01876; Drug: Ipilimumab |
| Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Nivolumab; Drug: Ipilimumab |
| Phase 2 Group C2 PD-1/PD-L1: INCAGN01876 300 mg + ipilimumab 1 mg/kg | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Ipilimumab |
| Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. Receives: Drug: INCAGN01876; Drug: Nivolumab |
| Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | 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. Receives: Drug: INCAGN01876; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to approximately 44.7 months
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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. [
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to approximately 27.4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start25 Apr 2017
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John E. Janik, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126110
- Sponsor's protocol ID
- INCAGN 1876-201
- Other IDs
- 2016-004989-25, 2016
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2017
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
- ClinicalTrials.gov ID
- NCT03126110
- Acronym / sponsor ID
- INCAGN 1876-201
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Keywords
- cervical cancer, endometrial cancer, gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ]), hepatocellular carcinoma (HCC), melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability-high (MSI-H) colorectal cancer (CRC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Incyte Biosciences International SàrlIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants 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. |
| Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. |
| Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. |
| Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. |
| Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants 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. |
| Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants 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. |
| Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants 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. |
| Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W | Experimental | Drug: INCAGN01876, Drug: IpilimumabParticipants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W). |
| Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W | Experimental | Drug: INCAGN01876, Drug: IpilimumabParticipants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W. |
| Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W | Experimental | Drug: INCAGN01876, Drug: IpilimumabParticipants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W. |
| Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab | Experimental | Drug: INCAGN01876, Drug: Nivolumab, Drug: IpilimumabParticipants 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. |
| Phase 2 Group C2 PD-1/PD-L1: INCAGN01876 300 mg + ipilimumab 1 mg/kg | Experimental | Drug: INCAGN01876, Drug: IpilimumabParticipants 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. |
| Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants 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. |
| Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. |
| Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. |
| Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg | Experimental | Drug: INCAGN01876, Drug: NivolumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
- Presence of measurable disease based on RECIST v1.1.
Key exclusion criteria (9 listed)
- Laboratory and medical history parameters not within the Protocol-defined range
- Prior treatment with any tumor necrosis factor super family agonist.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- Active autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCAGN01876In 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 (). | Drug | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W, Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W, Phase 1 Group 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 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: INCAGN01876 300 mg + ipilimumab 1 mg/kg, Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg |
| NivolumabNivolumab will be administered IV at the protocol-defined dose according to assigned treatment group. | Drug | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W, Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W, Phase 1 Group 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 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 D: INCAGN01876 + Nivolumab + Ipilimumab, Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg, Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg |
| IpilimumabIpilimumab will be administered IV at the protocol-defined dose according to assigned treatment group. | Drug | 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: INCAGN01876 300 mg + ipilimumab 1 mg/kg |
Primary outcome
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to approximately 27.4 months
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.
Phase 2: Objective Response Rate (ORR) Per RECIST v1.1
Time frame: up to approximately 44.7 months
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.
22 secondary outcomes
Phase 1: ORR Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: ORR Per Modified RECIST (mRECIST) v1.1
Time frame: up to approximately 44.7 months
Phase 2: ORR Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: Duration of Response (DOR) Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: DOR Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: DOR Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: DOR Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: Disease Control Rate (DCR) Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: DCR Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: DCR Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: DCR Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: Duration of Disease Control Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: Duration of Disease Control Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: Duration of Disease Control Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: Duration of Disease Control Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: Progression-free Survival (PFS) Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: PFS Per RECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: PFS Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 2: PFS Per mRECIST v1.1
Time frame: up to approximately 44.7 months
Phase 1: Overall Survival
Time frame: up to approximately 44.7 months
Phase 2: Overall Survival
Time frame: up to approximately 44.7 months
Phase 2: : Number of Participants With Any TEAE
Time frame: up to approximately 27.4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E. Janik, MD study director
Incyte Corporation
38 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCAGN01876, Nivolumab and Ipilimumab in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 38 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Spain, Belgium, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to approximately 27.4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.