Spots Global Cancer Trial Database for Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG

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Trial Identification

Brief Title: Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG

Official Title: Perioperative Immunotherapy vs. Chemo-immunotherapy Stratified by Early Response Evaluation in Patients With Advanced Gastric Cancer (GC) and Adenocarcinoma of the Esophago-gastric Junction (AEG)

Study ID: NCT04062656

Conditions

Gastric Cancer

Adenocarcinoma of the Esophagogastric Junction

Interventions

5-Fluorouracil (5-FU)

Folic acid (FA)

Study Description

Brief Summary: IMAGINE is a Phase II, randomized, two-arm, chemotherapy controlled modular trial in subjects with histologically confirmed, resectable gastric cancer (GC) or adenocarcinoma of the gastroesophageal junction (AEG). Up to 22 patients will be included in each arm of the trial.

Detailed Description: This study will determine the rate of pathological complete responses (pCR) as determined by pathological examination of the resected tumor following preoperative systemic therapy. A pCR rate of 15% is expected with neoadjuvant FLOT chemotherapy. An increase to 35% is estimated to be clinically relevant when patients are treated with either nivolumab in combination with chemotherapy (Arm B) or nivolumab and another immuno-oncology (IO) agent (relatlimab) in Arm D. Additional objectives include resection rate, diseasefree survival (DFS), median overall survival (OS), patient's quality of life (QoL), and safety and tolerability of the treatment. Furthermore, translational endpoints will be investigated.