RECRUITING

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

Conditions

HER2-positive Gastric Cancer Gastroesophageal Junction Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-03-01

Study Completion:2030-12-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06764875

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Lack of physiological integrity of the upper gastrointestinal tract. * Known dihydropyrimidine dehydrogenase enzyme deficiency. * Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label. * 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. * Persistent toxicities caused by previous anti-cancer therapy. * 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. * Uncontrolled infection including tuberculosis and active hepatitis A infection. * Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals. * Recent receipt of live, attenuated vaccine. * Chronic/active HBV or HCV infection unless controlled. * Clinically significant cardiac or psychological conditions. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Lung-specific intercurrent clinically significant illnesses. * Any active non-infectious skin disease requiring systemic treatment. * A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART). * History of any of the following: drug-induced severe cutaneous adverse reaction. * Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors. * 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. * Current or prior use of immunosuppressive medication within 14 days before study intervention.

Inclusion Criteria

Exclusion Criteria

* 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.

* Lack of physiological integrity of the upper gastrointestinal tract.
* Known dihydropyrimidine dehydrogenase enzyme deficiency.
* Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
* 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.
* Persistent toxicities caused by previous anti-cancer therapy.
* 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.
* Uncontrolled infection including tuberculosis and active hepatitis A infection.
* Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
* Recent receipt of live, attenuated vaccine.
* Chronic/active HBV or HCV infection unless controlled.
* Clinically significant cardiac or psychological conditions.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Lung-specific intercurrent clinically significant illnesses.
* Any active non-infectious skin disease requiring systemic treatment.
* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
* History of any of the following: drug-induced severe cutaneous adverse reaction.
* Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
* 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.
* Current or prior use of immunosuppressive medication within 14 days before study intervention.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Duarte, California, 91010

United States

Research Site

Los Angeles, California, 90089

United States

Research Site

Santa Monica, California, 90404

United States

Research Site

Walnut Creek, California, 94598

United States

Research Site

Aurora, Colorado, 80045

United States

Research Site

Marietta, Georgia, 30060

United States

Research Site

Chicago, Illinois, 60637

United States

Research Site

Louisville, Kentucky, 40217

United States

Research Site

Silver Spring, Maryland, 20904

United States

Research Site

Boston, Massachusetts, 02114

United States

Research Site

Grand Rapids, Michigan, 49503

United States

Research Site

Burnsville, Minnesota, 55337

United States

Research Site

Kansas City, Missouri, 64111

United States

Research Site

New York, New York, 10065

United States

Research Site

Cincinnati, Ohio, 45220

United States

Research Site

Nashville, Tennessee, 37232

United States

Research Site

Dallas, Texas, 75246

United States

Research Site

Webster, Texas, 77598

United States

Research Site

Fairfax, Virginia, 22031

United States

Research Site

Richmond, Virginia, 23235

United States

Research Site

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01

Study Completion Date2030-12-09

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2030-12-09

Terms related to this study

Additional Relevant MeSH Terms

HER2-positive Gastric Cancer
Gastroesophageal Junction Adenocarcinoma