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An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
Sponsor: Hoffmann-La Roche
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
Atezolizumab
Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease.
Capecitabine
Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles.
Oxaliplatin
Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles.
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