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RECRUITING

NCT06764875

PHASE3

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

840

Start Date

2025-03-01

Completion Date

2030-12-09

Last Updated

2026-10-16

Healthy Volunteers

Conditions

HER2-positive Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Rilvegostomig

Q3W, intravenous infusion

DRUG

Trastuzumab deruxtecan

Q3W, intravenous infusion

DRUG

Trastuzumab

Q3W, intravenous infusion

DRUG

Pembrolizumab

Q3W, intravenous infusion

DRUG

5-fluorouracil

Q3W, intravenous infusion

DRUG

Capecitabine

BID, oral administration

DRUG

Cisplatin

Q3W, intravenous infusion

DRUG

Oxaliplatin

Q3W, intravenous infusion

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.

Locations (304)

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Anchorage, Alaska, United States

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Phoenix, Arizona, United States

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Duarte, California, United States

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La Jolla, California, United States

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Los Alamitos, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Santa Monica, California, United States

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Solvang, California, United States

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Upland, California, United States

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Walnut Creek, California, United States

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Aurora, Colorado, United States

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Newark, Delaware, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Athens, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Hinsdale, Illinois, United States

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Niles, Illinois, United States

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Dyer, Indiana, United States

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Waukee, Iowa, United States

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Lexington, Kentucky, United States

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Silver Spring, Maryland, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Burnsville, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Summit, New Jersey, United States

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Santa Fe, New Mexico, United States

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Albany, New York, United States

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Clifton Park, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lancaster, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Round Rock, Texas, United States

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Webster, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Fairfax, Virginia, United States

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Richmond, Virginia, United States

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Charleston, West Virginia, United States

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Madison, Wisconsin, United States

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Buenos Aires, Argentina

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Ciudad Autónoma Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Rosario, Argentina

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Rosario, Argentina

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Viedma, Argentina

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Darlinghurst, Australia

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Heidelberg, Australia

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Murdoch, Australia

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Westmead, Australia

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Linz, Austria

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Salzburg, Austria

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Vienna, Austria

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Wiener Neustadt, Austria

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Barretos, Brazil

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Brasília, Brazil

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Campo Grande, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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Vitória, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Barrie, Ontario, Canada

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Brampton, Ontario, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Lévis, Quebec, Canada

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Montreal, Quebec, Canada

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Port Montt, Chile

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Rancagua, Chile

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Santiago, Chile

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Santiago, Chile

And 204 more locations on ClinicalTrials.gov

Clinical Research Directory

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (304)