Rilvegostomig for HER2-positive Gastric Cancer Treatment
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
840 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for individuals with advanced stomach cancer that tests positive for HER2. Participants will receive a combination of rilvegostomig, chemotherapy, and other treatments to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with HER2-positive gastric cancer
I have a PD-L1 score of at least 1
I can provide a tumor sample from a recent biopsy
I have not received previous treatment for my cancer
I have measurable cancer as confirmed by a doctor
I have good overall health with performance status of 0 or 1
I have normal organ function
My heart function is normal with LVEF of at least 50%
You may not be able to join if
I cannot eat or have issues with my digestive tract
I have a serious heart or mental health condition
I have an ongoing infection that needs IV treatment
I have a history of certain severe skin reactions to drugs
I have had any major surgery recently
I have been treated with immune-suppressing medications recently
I have active liver infections like HBV or HCV
I have a history of lung problems or autoimmune diseases
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. Rilvegost…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. HER2 positive for gastric cancer on a tumor biopsy.
2. PD-L1 combined positive score (CPS) ≥ 1.
3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ ade…
Inclusion Criteria:
1. HER2 positive for gastric cancer on a tumor biopsy.
2. PD-L1 combined positive score (CPS) ≥ 1.
3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.
5. WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Have measurable target disease assessed by the Investigator based on RECIST v1.1.
7. Have adequate organ and bone marrow function.
8. LVEF ≥ 50% within 28 days before randomization.
9. Adequate treatment washout period before randomization.
Exclusion Criteria:
1. Lack of physiological integrity of the upper gastrointestinal tract.
2. Known dihydropyrimidine dehydrogenase enzyme deficiency.
3. Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.
5. Persistent toxicities caused by previous anti-cancer therapy.
6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
7. Uncontrolled infection including tuberculosis and active hepatitis A infection.
8. Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
9. Recent receipt of live, attenuated vaccine.
10. Chronic/active HBV or HCV infection unless controlled.
11. Clinically significant cardiac or psychological conditions.
12. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
13. History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
14. Lung-specific intercurrent clinically significant illnesses.
15. Any active non-infectious skin disease requiring systemic treatment.
16. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
17. History of any of the following: drug-induced severe cutaneous adverse reaction.
18. Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
19. Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
20. Current or prior use of immunosuppressive medication within 14 days before study intervention.
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