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

Sponsor
Hoffmann-La Roche
Study ID
NCT05251948
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Gastric and Gastroesophageal Junction Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease.
  • Capecitabine — DRUG
    Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles.
  • Oxaliplatin — DRUG
    Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles.
  • Tiragolumab — DRUG
    Tiragolumab is administered by IV infusion on Day 1 of each 21 day cycle.

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Apr 2026
Primary completion
Sep 4, 2025
Completion
Sep 4, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Atezo + CAPOX (capecitabine + oxaliplatin)
    Participants in the atezolizumab plus capecitabine plus oxaliplatin in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
  • Experimental: Atezo + CAPOX +Tira
    Participants in the atezolizumab plus capecitabine plus oxaliplatin plus tiragolumab arm in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 42.1 months ]

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