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TERMINATED
NCT05251948
PHASE1/PHASE2

An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population. Cohort 1 will enroll participants with inoperable locally advanced, metastatic, or advanced GC or GEJC, with adenocarcinoma confirmed as the predominant histology, who have not received prior systemic therapy for advanced or metastatic disease. Eligible participants will initially be randomly assigned to one of treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

Official title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma (MORPHEUS C-Gastric and Gastroesophageal Junction Carcinoma)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-03-01

Completion Date

2025-09-04

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease.

DRUG

Capecitabine

Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles.

DRUG

Oxaliplatin

Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles.

DRUG

Tiragolumab

Tiragolumab is administered by IV infusion on Day 1 of each 21 day cycle.

Locations (11)

The General Hospital of People?s Liberation Army (301 Hospital)

Beijing, China

the First Hospital of Jilin University

Changchun, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Affiliated Hopsital of Jining Medical University

Jining, China

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, China

Nan Tong Tumor Hospital

Nantong, China

Shanxi Province Cancer Hospital

Taiyuan, China

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, China