A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer (FRACTION-GC)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: Rucaparib; Biological: Nivolumab; Biological: BMS-986205; Biological: Relatlimab; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02935634

2016-002807-24 (EudraCT Number)

CA018-003

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

190 participants in 6 patient groups

Nivolumab + Ipilimumab

Active Comparator group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Nivolumab + Relatlimab

Experimental group

Treatment:

Biological: Relatlimab

Biological: Nivolumab

Nivolumab + BMS-986205

Experimental group

Treatment:

Biological: BMS-986205

Biological: Nivolumab

Nivolumab + Rucaparib

Experimental group

Treatment:

Biological: Nivolumab

Drug: Rucaparib

Ipilimumab + Rucaparib

Experimental group

Treatment:

Biological: Ipilimumab

Drug: Rucaparib

Nivolumab + Ipilimumab + Rucaparib

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Drug: Rucaparib