A Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)

Sponsor
Hoffmann-La Roche
Study ID
NCT04933227
Phase
PHASE2
Status
Terminated

Conditions

  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.
  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m\^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.

Study Details

This study is designed to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment in participants with HER2-negative unresectable advanced, recurrent or metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ AC).

Key Dates

Start date
Aug 6, 2021
Status verified
Nov 2024
Primary completion
Nov 17, 2023
Completion
Nov 17, 2023

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezo + Tira + XELOX
    Atezolizumab plus tiragolumab in combination with XELOX (oxaliplatin and capecitabine) will be administered during Cycles 1-4 (each cycle is 21 days). During Cycle 5 and beyond atezolizumab and tiragolumab will be administered on Day 1 of each 21-day cycle. Participants will receive study treatment until disease progression, unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Primary Outcome Measure

Objective Response Rate (ORR) in the Full Analysis Set (FAS) Population [ Time Frame: Up to approximately 20 months ]

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