A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Rilvegostomig: Q3W, intravenous infusion
Trastuzumab deruxtecan: Q3W, intravenous infusion
Trastuzumab: Q3W, intravenous infusion
Pembrolizumab: Q3W, intravenous infusion
5-fluorouracil: Q3W, intravenous infusion
Capecitabine: BID, oral administration
Cisplatin: Q3W, intravenous infusion
Oxaliplatin: Q3W, intravenous infusion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression free survival (PFS) — Up to approximately 6 years
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. - Overall Survival (OS) — Up to approximately 6 years
OS is defined as time from randomization until the date of death due to any cause.
Trial sites (302)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Anchorage | Alaska | Recruiting |
| Research Site | Phoenix | Arizona | Recruiting |
| Research Site | Duarte | California | Recruiting |
| Research Site | La Jolla | California | Recruiting |
| Research Site | Los Alamitos | California | Recruiting |
| Research Site | Los Angeles | California | Not Yet Recruiting |
| Research Site | Los Angeles | California | Recruiting |
| Research Site | Santa Monica | California | Recruiting |
| Research Site | Solvang | California | Recruiting |
| Research Site | Upland | California | Recruiting |
| Research Site | Walnut Creek | California | Recruiting |
| Research Site | Aurora | Colorado | Recruiting |
| Research Site | Newark | Delaware | Not Yet Recruiting |
| Research Site | Jacksonville | Florida | Not Yet Recruiting |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Orlando | Florida | Recruiting |
| Research Site | Athens | Georgia | Withdrawn |
| Research Site | Marietta | Georgia | Recruiting |
| Research Site | Chicago | Illinois | Recruiting |
| Research Site | Chicago | Illinois | Not Yet Recruiting |
| Research Site | Evanston | Illinois | Not Yet Recruiting |
| Research Site | Hinsdale | Illinois | Recruiting |
| Research Site | Niles | Illinois | Recruiting |
| Research Site | Dyer | Indiana | Withdrawn |
| Research Site | Waukee | Iowa | Not Yet Recruiting |
| Research Site | Lexington | Kentucky | Not Yet Recruiting |
| Research Site | Louisville | Kentucky | Recruiting |
| Research Site | Silver Spring | Maryland | Recruiting |
| Research Site | Boston | Massachusetts | Withdrawn |
| Research Site | Boston | Massachusetts | Withdrawn |
| Research Site | Worcester | Massachusetts | Withdrawn |
| Research Site | Detroit | Michigan | Recruiting |
| Research Site | Grand Rapids | Michigan | Recruiting |
| Research Site | Burnsville | Minnesota | Recruiting |
| Research Site | Kansas City | Missouri | Withdrawn |
| Research Site | St Louis | Missouri | Recruiting |
| Research Site | Omaha | Nebraska | Recruiting |
| Research Site | Reno | Nevada | Recruiting |
| Research Site | Summit | New Jersey | Recruiting |
| Research Site | Santa Fe | New Mexico | Recruiting |
+ 262 more sites — see the full list on the official registry below.
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Herceptin (trastuzumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →More AstraZeneca trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06764875 on ClinicalTrials.gov ↗ ← All trials in Spain