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)

Phase 1/2 Terminated NCT03281369

Condition	Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Phase	Phase 1/2
Sponsor	Hoffmann-La Roche
Status	Terminated
Enrollment	219 participants
Interventions	5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, Atezolizumab, Cobimetinib
Start date	Oct 13, 2017
Completion date	Oct 9, 2025
Results posted	Aug 3, 2026

Summary

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.

Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to RECIST v1.1

From randomization up to approximately 84.2 months · percentage of participants

Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib	40.0 percentage of participants
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)	16.7 percentage of participants
Stage 1 Cohort 2: Atezolizumab + PEGPH20	0 percentage of participants
Stage 1 Cohort 2: Atezolizumab + BL-8040	15.4 percentage of participants
Stage 1 Cohort 2: Atezolizumab + Linagliptin	21.4 percentage of participants
Stage 1: Cisplatin + 5-FU (Control)	47.8 percentage of participants

Difference in Overall Response Rates	-16.67 (95% CI -45.77–12.43)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patient — National Cancer Institute (NCI)
Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 — National Cancer Institute (NCI)
Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Un — University of Southern California
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresecta — National Cancer Institute (NCI)
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients — National Cancer Institute (NCI)
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poo — ECOG-ACRIN Cancer Research Group

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

English 한국어 日本語中文 Русский