A Phase 2 interventional study of Rilvegostomig and Volrustomig in Gastric Cancer, sponsored by AstraZeneca. Recruiting at 44 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
Approximately 360 participants will be assigned across 4 substudies, with approximately 60 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy/cohort.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 163 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Drug: Volrustomig · Drug: FOLFOX · Drug: XELOX
Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Drug: Rilvegostomig · Drug: FOLFOX · Drug: XELOX
AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
Drug: Volrustomig · Drug: AZD0901 · Drug: 5-Fluorouracil · Drug: Capecitabine
Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine
Drug: Rilvegostomig · Drug: AZD0901 · Drug: 5-Fluorouracil · Drug: Capecitabine
Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil
Drug: Rilvegostomig · Drug: AZD0901 · Drug: 5-Fluorouracil
Sonesitatug vedotin (AZD0901) plus capecitabine
Drug: AZD0901 · Drug: Capecitabine
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
capecitabine and oxaliplatin
an anti Claudin18.2 ADC; IV infusion
5-FU, IV infusion
Oral take
ORR (per RECIST 1.1 as assessed by Investigator)
the proportion of participants who have a confirmed complete response or confirmed partial response, as determined by the Investigator at local site per RECIST 1.1.
Time frame: Through substudy completion, an average of 2 years
PFS6 (per RECIST 1.1 as assessed by Investigator)
the proportion of participants alive and progression-free at 6 months.
Time frame: Through substudy completion, an average of 2 years
PFS per RECIST 1.1 as assessed by the Investigator
the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression.
Time frame: Through substudy completion, an average of 2 years
OS
the time from the start of study intervention until the date of death due to any cause.
Time frame: Through substudy completion, an average of 2 years
other safety related endpoints
Incidence of AEs, AESIs, and SAEs.
Time frame: Through substudy completion, an average of 2 years
DoR per RECIST 1.1 based on Investigator assessment.
the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression.
Time frame: Through substudy completion, an average of 2 years
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
No publications or documents are linked to this record.
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