AB154, AB122 + Chemotherapy vs Nivolumab + Chemotherapy in Oesophageal/Gastric Cancer
Research type
Research Study
Full title
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously-Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma.
IRAS ID
1006095
Contact name
Allan Sison
Contact email
Sponsor organisation
Arcus Biosciences, Inc.
Eudract number
2022-002222-27
Clinicaltrials.gov Identifier
Research summary
Arcus Biosciences Inc., is running an open-label randomised phase 3 study to evaluate the overall survival of participants with previously untreated locally advanced unresectable or metastatic gastric, Gastroesophageal Junction (GEJ), and oesophageal adenocarcinoma who are treated with domvanalimab and zimberelimab plus chemotherapy compared to those treated with nivolumab plus chemotherapy.
Gastric and oesophageal cancers are the 5th and 7th most frequently diagnosed cancers, respectively. Standard-of-care chemotherapy now includes programmed death ligand 1 (PD-L1) inhibitors. However, with a 5-year survival rate of 5%, it’s clear that patient outcomes still need to improve. New research supports the addition of anti-T cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) antibody to chemotherapy, with results suggesting improved clinical benefits. This study aims to investigate the efficacy of combining domvanalimab (anti-TIGIT) and zimberelimab (anti-PD-1) antibodies and chemotherapy.
Around 970 participants diagnosed with the above-mentioned cancers are planned to take part in the study. Eligible participants will be randomised 1:1, either to experimental Arm A, combining domvanalimab, zimberelimab and chemotherapy, or comparator Arm B, receiving Nivolumab (approved anti-PD-1 antibody) and chemotherapy. Participants assigned to Arm A will be administered domvanalimab and zimberelimab once every 3 or 4 weeks, and either FOLFOX chemotherapy every 2 weeks or CAPOX chemotherapy every 3 weeks. Participants assigned to Arm B will be administered Nivolumab every 2 or 3 weeks with either FOLFOX every 2 weeks, or CAPOX every 3 weeks. Treatment may involve a minimum of 3 study visits, and last a minimum of 5 weeks.
Study assessments will include: vital signs, blood tests, ECGs, physical examination, CT or MRI scans, and possible tumour biopsy.
Arcus Biosciences Inc. is the sponsor and will organise this study, funding by Arcus and Gilead.
REC name
London - Central Research Ethics Committee
REC reference
22/LO/0775
Date of REC Opinion
13 Jan 2023
REC opinion
Further Information Favourable Opinion