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

NCT04062656 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • GWT-TUD GmbH

    collaborator OTHER

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Stefan Kasper-Virchow, Prof. · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2024-03-31
Completion
2025-06-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062656 on ClinicalTrials.gov