A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer

NCT ID: NCT02935634

Last Updated: 2023-06-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2022-05-11

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivolumab + Ipilimumab

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab + Relatlimab

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Relatlimab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab + BMS-986205

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

BMS-986205

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab + Rucaparib

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Rucaparib

Intervention Type DRUG

Specified dose on specified days

Ipilimumab + Rucaparib

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Rucaparib

Intervention Type DRUG

Specified dose on specified days

Nivolumab + Ipilimumab + Rucaparib

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Rucaparib

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Ipilimumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Relatlimab

Specified dose on specified days

Intervention Type BIOLOGICAL

BMS-986205

Specified dose on specified days

Intervention Type BIOLOGICAL

Rucaparib

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Opdivo BMS-936558 Yervoy BMS-734016 BMS-986016 Rubraca

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clovis Oncology, Inc.

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status

Local Institution - 0020

Duarte, California, United States

Site Status

University Of Colorado

Aurora, Colorado, United States

Site Status

Local Institution - 0032

New Haven, Connecticut, United States

Site Status

Local Institution - 0036

Washington D.C., District of Columbia, United States

Site Status

UF Health Medical Oncology - Davis Cancer Pavilion

Gainesville, Florida, United States

Site Status

Local Institution - 0038

Jacksonville, Florida, United States

Site Status

Local Institution - 0006

Baltimore, Maryland, United States

Site Status

Local Institution - 0017

Rochester, Minnesota, United States

Site Status

Local Institution - 0003

St Louis, Missouri, United States

Site Status

Local Institution - 0001

Hackensack, New Jersey, United States

Site Status

Local Institution - 0007

New York, New York, United States

Site Status

Local Institution - 0002

Portland, Oregon, United States

Site Status

Local Institution - 0005

Philadelphia, Pennsylvania, United States

Site Status

UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0004

Seattle, Washington, United States

Site Status

Local Institution - 0035

Westmead, New South Wales, Australia

Site Status

Local Institution - 0033

Heidelberg, Victoria, Australia

Site Status

Local Institution

Randwick, , Australia

Site Status

Local Institution

Edmonton, Alberta, Canada

Site Status

Local Institution

Vancouver, British Columbia, Canada

Site Status

Local Institution

Ottawa, Ontario, Canada

Site Status

Local Institution - 0025

Toronto, Ontario, Canada

Site Status

Local Institution - 0021

Toronto, Ontario, Canada

Site Status

Local Institution - 0039

Heidelberg, , Germany

Site Status

Local Institution - 0043

Leipzig, , Germany

Site Status

Local Institution

Ramat Gan, , Israel

Site Status

Local Institution

Tel Aviv, , Israel

Site Status

Local Institution - 0014

Milan, Lombardy, Italy

Site Status

IRCCS Istituto Nazionale Tumori Milano

Milan, , Italy

Site Status

Local Institution

Amsterdam, , Netherlands

Site Status

Local Institution

Utrecht, , Netherlands

Site Status

Local Institution - 0050

Singapore, , Singapore

Site Status

Local Institution - 0041

Chur, Graubünden (de), Switzerland

Site Status

Local Institution - 0042

Zurich, , Switzerland

Site Status

Countries

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United States Australia Canada Germany Israel Italy Netherlands Singapore Switzerland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2016-002807-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA018-003

Identifier Type: -

Identifier Source: org_study_id

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