BridgeMD
A trial comparing the treatment of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan to the standard treatment in patients with HER2-positive gastric cancer.
EU CTIS ID: 2024-512583-57-00
What this study is testing
To evaluate the efficacy of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab, as measured by Progression-free Survival (PFS) per Blinded Independent Central Review and Overall Survival (OS).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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.
- Have measurable target disease assessed by the Investigator based on RECISTv1.1.
You likely can't join if
- Lack of physiological integrity of the upper gastrointestinal tract.
- Any concurrent anti-cancer treatment with the exception of receptor activator ofnuclear 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.
- Known dihydropyrimidine dehydrogenase enzyme deficiency.
- Current or prior use of immunosuppressive medication within 14 days before study intervention.
- Contraindication to pembrolizumab or trastuzumab, contraindications tofluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
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 RECISTv1.1.
- 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.
- Any concurrent anti-cancer treatment with the exception of receptor activator ofnuclear 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.
- Known dihydropyrimidine dehydrogenase enzyme deficiency.
- Current or prior use of immunosuppressive medication within 14 days before study intervention.
- Contraindication to pembrolizumab or trastuzumab, contraindications tofluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
- History of another primary malignancy except for malignancy treated with curativeintent with no known active disease within 3 years before the first dose of studyintervention and of low potential risk for recurrence.
- Persistent toxicities caused by previous anti-cancer therapy.
- Has 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.
- Chronic/active HBV or HCV infection unless controlled.
- Recent receipt of live, attenuated vaccine.
- Clinically significant cardiac or psychological conditions.
- Active or prior documented autoimmune or inflammatory disorders requiringchronic treatment with steroids or other immunosuppressive treatment.
- History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or wheresuspected 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, peritonealshunt, or cell-free and concentrated ascites reinfusion therapy (CART).
- History of any of the following: drug-induced severecutaneous adverse reaction.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Brazil
- Korea, Republic of
- Taiwan
- Chile
- India
- China
- Peru
- Malaysia
- Turkey
- Canada
- Vietnam
- Hong Kong
- United Kingdom
- Japan
- Thailand
- Argentina
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Brazil; Korea, Republic of; Taiwan; Chile and 12 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 EU CTIS; the study team decides eligibility.