Purpose

The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 - At least 1 lesion with measurable disease

Exclusion Criteria

  • HER2-positive tumor and previously untreated with trastuzumab - Suspected, known or progressive central nervous system metastases - Other active malignancy requiring concurrent intervention - Active, known or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Nivolumab + Ipilimumab
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified days
    Other names:
    • Yervoy
    • BMS-734016
Experimental
Nivolumab + Relatlimab
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558
  • Biological: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016
Experimental
Nivolumab + BMS-986205
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558
  • Biological: BMS-986205
    Specified dose on specified days
Experimental
Nivolumab + Rucaparib
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558
  • Drug: Rucaparib
    Specified dose on specified days
    Other names:
    • Rubraca
Experimental
Ipilimumab + Rucaparib
  • Biological: Ipilimumab
    Specified dose on specified days
    Other names:
    • Yervoy
    • BMS-734016
  • Drug: Rucaparib
    Specified dose on specified days
    Other names:
    • Rubraca
Experimental
Nivolumab + Ipilimumab + Rucaparib
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified days
    Other names:
    • Yervoy
    • BMS-734016
  • Drug: Rucaparib
    Specified dose on specified days
    Other names:
    • Rubraca

More Details

Status
Completed
Sponsor
Bristol-Myers Squibb

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.