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

Phase 2

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Biological: Ipilimumab; Biological: Nivolumab; Biological: Relatlimab; Biological: BMS-986205; Drug: Rucaparib

• Registration Number: NCT02935634
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-17
• Study Start: 2016-11-29
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2023-05
• Results First Submitted: 2023-05-09
• Results First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Results First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ipilimumab + Rucaparib	Ipilimumab	-
Nivolumab + Ipilimumab	Nivolumab	-
Nivolumab + Relatlimab	Relatlimab	-
Nivolumab + BMS-986205	Nivolumab	-
Nivolumab + Ipilimumab	Ipilimumab	-
Nivolumab + Ipilimumab + Rucaparib	Nivolumab	-
Nivolumab + Relatlimab	Nivolumab	-
Nivolumab + BMS-986205	BMS-986205	-
Nivolumab + Rucaparib	Nivolumab	-
Nivolumab + Ipilimumab + Rucaparib	Ipilimumab	-
Nivolumab + Ipilimumab + Rucaparib	Rucaparib	-
Nivolumab + Rucaparib	Rucaparib	-
Ipilimumab + Rucaparib	Rucaparib	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) by Investigator	From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)	ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks	24 weeks after first dose	The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.
Median Duration of Response (DOR)	From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)	Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests	From first dose to 100 days after last dose of study therapy (approximately 30 months)	The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death	From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
Number of Participants With Laboratory Abnormalities in Specific Liver Tests	From first dose to 100 days after last dose of study therapy (approximately 30 months)	The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

Trial Locations

Locations (28)

Local Institution - 0001; 🇺🇸 Hackensack, New Jersey, United States

Local Institution - 0043; 🇩🇪 Leipzig, Germany

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

University Of Colorado; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0032; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 0036; 🇺🇸 Washington, District of Columbia, United States

UF Health Medical Oncology - Davis Cancer Pavilion; 🇺🇸 Gainesville, Florida, United States

Local Institution - 0038; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0003; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0017; 🇺🇸 Rochester, Minnesota, United States

Local Institution - 0007; 🇺🇸 New York, New York, United States

Local Institution - 0002; 🇺🇸 Portland, Oregon, United States

Local Institution - 0005; 🇺🇸 Philadelphia, Pennsylvania, United States

Local Institution - 0004; 🇺🇸 Seattle, Washington, United States

Local Institution - 0035; 🇦🇺 Westmead, New South Wales, Australia

Local Institution - 0033; 🇦🇺 Heidelberg, Victoria, Australia

Local Institution; 🇳🇱 Utrecht, Netherlands

Local Institution - 0021; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0039; 🇩🇪 Heidelberg, Germany

IRCCS Istituto Nazionale Tumori Milano; 🇮🇹 Milano, Italy

Local Institution - 0041; 🇨🇭 Chur, Graubünden (de), Switzerland

Local Institution - 0020; 🇺🇸 Duarte, California, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0014; 🇮🇹 Milan, Lombardia, Italy

Local Institution - 0050; 🇸🇬 Singapore, Singapore

Local Institution - 0042; 🇨🇭 Zuerich, Switzerland

Local Institution - 0006; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0025; 🇨🇦 Toronto,, Ontario, Canada