Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
NCT ID: NCT03126110
Last Updated: 2025-08-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
145 participants
INTERVENTIONAL
2017-04-25
2021-11-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
NCT03277352
Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
NCT02646748
Intratumoral Tilsotolimod, a TLR-9 Agonist, Together With Intratumoral Ipilimumab and Intravenous Nivolumab in Patients With Advanced Cancers
NCT04270864
Intratumoral Injection of Autologous CD1c (BDCA-1)+ MyDC, Avelumab, and Ipilimumab Plus Systemic Nivolumab
NCT03707808
A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy
NCT05276310
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 5.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
INCAGN01876
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 ().
Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
INCAGN01876
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 ().
Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
INCAGN01876
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 ().
Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 2 Group C2 PD-1/PD-L1: INCAGN01876 300 mg + ipilimumab 1 mg/kg
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.
INCAGN01876
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 ().
Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INCAGN01876
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Nivolumab
Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Ipilimumab
Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Phase 1: Subjects with advanced or metastatic solid tumors.
* Phase 1: Subjects who have disease progression after treatment with available therapies.
* Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
* Presence of measurable disease based on RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion Criteria
* Prior treatment with any tumor necrosis factor super family agonist.
* Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
* Active autoimmune disease.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
* Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Biosciences International Sàrl
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John E. Janik, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University - Siteman Cancer Center
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Oklahoma, Sarah Cannon Research Institute
Oklahoma City, Oklahoma, United States
Providance Portland Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh, UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, Sarah Cannon Research Institute
Nashville, Tennessee, United States
BUMC Mary Crowley Cancer Research Centers
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Scientia Clinical Research
Randwick, New South Wales, Australia
Greenslopes Private Hospital
Brisbane, Queensland, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Linear Clinical Research
Perth, Western Australia, Australia
CHA Centre Hospitalier de l'Ardenne
Libramont, Chevigny, Belgium
Saint Augustinus Hospital
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
CHU Brugmann
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Charleroi, , Belgium
Ghent University Hospital
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Clinico y Provincial de Barcelona
Barcelona, , Spain
Institut Catala D'Oncologia-Badalona
Barcelona, , Spain
Hospital Vall de Hebron
Barcelona, , Spain
Hospital Reina Sophia
Córdoba, , Spain
University Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario Doce de Octubre
Madrid, , Spain
Hospital HM Sanchinarro
Madrid, , Spain
Clinica Universidad De Navarra (CUN)
Pamplona, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-004989-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCAGN 1876-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.