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New treatment option for HER2-positive Gastric Cancer
Official title A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
ClinicalTrials.gov ID: NCT06764875
What this study is testing
What is Rilvegostomig?
Rilvegostomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2-positive gastric cancer.
Also referred to as AZD2936.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first...
- 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...
See the full eligibility 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.
- LVEF ≥ 50% 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Duarte, California, United States
- Glendale, California, United States
- La Jolla, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Solvang, California, United States
- Upland, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Newark, Delaware, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Athens, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Hinsdale, Illinois, United States
+ 230 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Phoenix, Arizona, United States; Duarte, California, United States; Glendale, California, United States; La Jolla, California, United States; Los Alamitos, California, United States and 244 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.