NCT04062656

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

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Adenocarcinoma of the Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240mg administered IV over 30 minutes Nivolumab 480mg should be administered IV over 60 minutes
DRUG	relatlimab	relatlimab (80mg flat dose) administered IV over 60 min
DRUG	Oxaliplatin	Oxaliplatin 85mg/m² IV over 1 h
DRUG	Docetaxel	Docetaxel 50mg/m² IV over 1 h
DRUG	5-Fluorouracil (5-FU)	5-fluorouracil 2600mg/m² IV over 24h
DRUG	Folic acid (FA)	Folic acid 200mg/m² IV over 30 min

Timeline

• Start date: 2019-09-26
• Primary completion: 2024-03-01
• Completion: 2025-06-01
• First posted: 2019-08-20
• Last updated: 2024-03-12

Locations

3 sites across 1 country: Germany