GEMINI-PeriOp GC
Research type
Research Study
Full title
A Master Protocol for an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants with Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
IRAS ID
1011929
Contact name
Gergana Genova
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Researchers are looking for a better way to treat locally advanced gastroesophageal cancer.
AstraZeneca (the sponsor of the study) are running a study to learn how safe different cancer treatment combinations given before and after surgery are, how well they work, and how they move through the body over time in adults with locally advanced gastroesophageal cancer.
This study will include approximately 150 participants across several countries globally.
The study is made of smaller “sub-studies”. In each sub-study, participants will take different combinations of cancer treatments. Participants will be assigned to a sub-study based on whether their tumors have the proteins CLDN18.2 and/or HER2 and when they join the trial. If the protein is present on the tumor, it is called “positive”. If it is not present, it is called “negative”. If a participant has the proteins CLDN18.2 and/or HER2, they will be assigned to Sub-study 1 or 2. All other participants will be assigned to Sub-study 3.
Sub-study 1: Participants will receive AZD0901 with rilvegostomig and chemotherapy. The chemotherapy treatment used in Sub-study 1 is called fluoropyrimidine, which is 1 of 2 different drugs (5-FU or capecitabine).
Sub-study 2: Participants will receive fluoropyrimidine chemotherapy, rilvegostomig, and another drug called trastuzumab deruxtecan (T-DXd).
Sub-study 3: Participants will receive rilvegostomig with another type of chemotherapy called FLOT, which is a combination of different drugs (5-FU, leucovorin, oxaliplatin, and docetaxel).
Participants will receive treatment for about 9 weeks before surgery. Surgery should take place within 4 to 8 weeks after the last dose of the last round of treatment. After surgery, participants will receive the assigned study treatment for another 9 weeks. After this time, some participants may continue receiving rilvegostomig alone for up to 42 weeks (about 10 months).REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0042
Date of REC Opinion
18 Jul 2025
REC opinion
Further Information Favourable Opinion