Rilvegostomig Combination for Stomach Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires an adequate treatment washout period before randomization, which means you may need to stop certain medications before starting the study. However, the specific medications you need to stop are not detailed in the protocol.
What data supports the effectiveness of the drug Rilvegostomig Combination for Stomach Cancer?
What safety information is available for Rilvegostomig (Trastuzumab Deruxtecan)?
Trastuzumab deruxtecan has been associated with some safety concerns, including a risk of interstitial lung disease (lung inflammation) and embryo-fetal toxicity (harm to unborn babies). Additionally, nausea and vomiting were reported in up to 78% of patients in clinical trials, with about 8% experiencing severe symptoms.12567
What makes the Rilvegostomig combination unique for treating stomach cancer?
The Rilvegostomig combination is unique because it includes trastuzumab deruxtecan, an antibody-drug conjugate that targets HER2 (a protein that can promote cancer growth) and delivers a powerful cancer-killing drug directly to the cancer cells. This approach may offer better outcomes for patients with HER2-positive stomach cancer compared to standard chemotherapy.12357
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for people with HER2-positive gastric or gastroesophageal junction adenocarcinoma that's advanced or spread and shows PD L1 CPS ≥ 1. Participants must not have had prior treatment for their cancer.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rilvegostomig in combination with fluoropyrimidine and T-DXd or other combinations depending on the arm
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Rilvegostomig
- Trastuzumab
- Trastuzumab deruxtecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology