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Study identifier: NCT03281369 Synced from ClinicalTrials.gov · August 04, 2026
● Terminated

A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

Condition: Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma  ·  Sponsor: Hoffmann-La Roche

PhasePhase 1/Phase 2
Planned participants219
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (28)

Mayo Clinic Cancer CenterScottsdale, Arizona, United States
Uni of Southern CaliforniaLos Angeles, California, United States
UCLA Jonsson Comprehensive Cancer CenterSanta Monica, California, United States
Columbia University Medical CenterNew York, New York, United States
Tennessee Oncology - NashvilleNashville, Tennessee, United States
The University of Texas MD Anderson Cancer CenterHouston, Texas, United States
Blacktown HospitalBlacktown, New South Wales, Australia
Monash Medical Centre-Moorabbin CampusClayton, Victoria, Australia
Peter MacCallum Cancer CentreMelbourne, Victoria, Australia
Rambam Health Care CampusHaifa, Israel
Sourasky Medical CentreTel Aviv, Israel
Seoul National University Bundang HospitalGyeonggi-do, South Korea

+ 16 more locations — full list on the registry record.

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