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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Incyte Biosciences International Sàrl
Study ID
NCT03126110
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Malignancies
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCAGN01876 — DRUG
    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 — DRUG
    Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
  • Ipilimumab — DRUG
    Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.

Study Details

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.

Key Dates

Start date
Apr 25, 2017
Status verified
Aug 2025
Primary completion
Nov 9, 2021
Completion
Nov 9, 2021

Study Design

Enrollment
145 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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).
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to approximately 27.4 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
University of FloridaGainesvilleFlorida32610-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University - Siteman Cancer CenterSt LouisMissouri37201-
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering CancerNew YorkNew York10065-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
University of Oklahoma, Sarah Cannon Research InstituteOklahoma CityOklahoma73104-
Providance Portland Medical CenterPortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of Pittsburgh, UPMC Cancer PavilionPittsburghPennsylvania15232-
Tennessee Oncology, Sarah Cannon Research InstituteNashvilleTennessee37201-
BUMC Mary Crowley Cancer Research CentersDallasTexas75230-
MD AndersonHoustonTexas77030-
Seattle Cancer Care AllianceSeattleWashington98109-

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By research site
The Angeles Clinic and Research Institute· Los Angeles, CAUniversity of Florida· Gainesville, FLKarmanos Cancer Institute· Detroit, MIWashington University - Siteman Cancer Center· St Louis, MOHackensack University Medical Center· Hackensack, NJMemorial Sloan Kettering Cancer· New York, NY

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