Rilvegostomig Combination for Stomach Cancer

Recruiting at176 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Research Team

Eligibility Criteria

This trial is for people with HER2-positive gastric or gastroesophageal junction adenocarcinoma that's advanced or spread and shows PD L1 CPS ≥ 1. Participants must not have had prior treatment for their cancer.

Inclusion Criteria

My organs and bone marrow are functioning well.

PD-L1 combined positive score (CPS) ≥ 1

I can provide a recent biopsy sample for cancer testing.

Exclusion Criteria

I recently received a live vaccine.

I haven't taken immunosuppressive drugs in the last 14 days.

My upper digestive system is not functioning properly.

Treatment Details

Interventions

• Rilvegostomig (Other)
• Trastuzumab (Monoclonal Antibodies)
• Trastuzumab deruxtecan (Monoclonal Antibodies)

Trial Overview The study tests Rilvegostomig combined with fluoropyrimidine and Trastuzumab Deruxtecan (Arm A) against a mix of trastuzumab, chemotherapy, and pembrolizumab (Arm B), plus an additional arm (C) to evaluate each component's contribution.

Participant Groups

Group I: Arm A Experimental Treatment 4 Interventions

T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)

Group II: Arm C Active Control 6 Interventions

Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)

Group III: Arm B Active Control 6 Interventions

Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology