A Phase ? Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
Stomach/ Gastric Cancer
Unknown Primary
18 Years and older, Male and Female
D702AC00001 (primary)
NCI-2025-03123
2024-512583-57-00
Summary
This is a Phase ?, 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.
Objectives
The purpose of this study is to assess 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.
This study will be conducted at up to 200-250 sites globally in approximately 25
countries.
Eligibility
- HER2 positive for gastric cancer on a tumor biopsy.
- PD-L1 combined positive score (CPS) = 1.
- Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
- Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.
- WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
- Have measurable target disease assessed by the Investigator based on RECIST v1.1.
- Have adequate organ and bone marrow function within 14 days before randomization.
- LVEF = 55% within 28 days before randomization.
- Adequate treatment washout period before randomization.
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