A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Biosciences International Sàrl
Study ID
NCT03241173
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Malignancies

Eligibility Criteria

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

Interventions

  • INCAGN01949 — DRUG
    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 — 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 INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

Key Dates

Start date
Oct 9, 2017
Status verified
Sep 2022
Primary completion
Sep 17, 2019
Completion
Sep 17, 2019

Study Design

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

Arms

  • Experimental: Phase 1, Dose Escalation: INCAGN01949 + Nivolumab
    INCAGN01949 (70, 200, 350, or 700 milligrams \[mg\]) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors
  • Experimental: Phase 1, Dose Escalation: INCAGN01949 + Ipilimumab
    INCAGN01949 (70, 200, 350, or 700 mg) combined with ipilimumab 1 mg/kilogram (kg) in participants with advanced or metastatic select solid tumors
  • Experimental: Phase 1, Dose Escalation: INCAGN01949 + Nivolumab + Ipilimumab
    INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors
  • Experimental: Phase 1, Safety Expansion: INCAGN01949 + Nivolumab
    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
  • Experimental: Phase 1, Safety Expansion: INCAGN01949 + Nivolumab + Ipilimumab
    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
  • Experimental: Phase 2, Part A: INCAGN01949 + nivolumab
    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)
  • Experimental: Phase 2, Part B: INCAGN01949; INCAGN01949 + nivolumab; INCAGN01949 + nivolumab + ipilimumab
    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

Primary Outcome Measure

Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: up to 17.4 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
The University of Alabama Birmingham (UAB)BirminghamAlabama90025-
Scottsdale Healthcare Hospitals DBA HonorHealthScottsdaleArizona85258-
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Mount Sinai Medical Center of Florida, Inc.MiamiFlorida33140-
University of MichiganAnn ArborMichigan48109-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
John Theurer Cancer Center At Hackensack UMCHackensackNew Jersey07601-
Rutgers, The State UniversityNew BrunswickNew Jersey08901-
New York University Clinical Cancer CenterNew YorkNew York10016-
University of Rochester Medical CenterRochesterNew York14642-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Providence Portland Medical CenterPortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Sarah Cannon Research Institute, LLC (SCRI)NashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Birmingham, AL

By research site
The University of Alabama Birmingham (UAB)· Birmingham, ALScottsdale Healthcare Hospitals DBA HonorHealth· Scottsdale, AZThe Angeles Clinic and Research Institute· Los Angeles, CAMount Sinai Medical Center of Florida, Inc.· Miami, FLUniversity of Michigan· Ann Arbor, MIBarbara Ann Karmanos Cancer Institute· Detroit, MI

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