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

Sponsor
University Hospital, Essen
Study ID
NCT04062656
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 26, 2019
Status verified
May 2023
Primary completion
Mar 31, 2024
Completion
Jun 1, 2025

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B - Nivolumab
    Responders * 6 preoperative cycles nivolumab (i.v., 240mg, q2w) * 4 postoperative cycles nivolumab (i.v., 240mg, q2w) * followed by nivolumab monotherapy for up to one year (i.v., 480mg, q4w) Non-responders * 2 preoperative cycles nivolumab (i.v., 240mg, q2w) * 4 additional cycles nivolumab (i.v., 240mg, q2w)+FLOT (i.v., 240mg, q2w) pre- and postoperative * followed by nivolumab monotherapy for up to one year (i.v., 480 mg, q4w)
  • Experimental: D - Nivolumab + relatlimab
    Responders * 6 preoperative cycles nivolumab (i.v.,240 mg, q2w) and relatlimab (i.v.,80 mg, q2w) * 4 postoperative cycles nivolumab (i.v.,240 mg, q2w) and relatlimab (i.v.,80 mg, q2w) * followed by nivolumab monotherapy for up to one year (i.v., 480mg, q4w) Non-responders * 2 preoperative cycles nivolumab (i.v.,240 mg, q2w) and relatlimab (i.v.,80 mg, q2w) * 4 additional cycles nivolumab (i.v.,240 mg, q2w)+FLOT (i.v.,q2w) pre- and postoperative * followed by nivolumab monotherapy for up to one year (i.v., 480mg, q4w)

Primary Outcome Measure

Rate of pathological complete responses [ Time Frame: 3 years ]

Related Studies