Preoperative Nivolumab in Patients With Locally Advanced Colon Cancer (T3 or T4): a Window-of-opportunity Study
- Sponsor
- National Cancer Institute, Naples
- Study ID
- NCT04123925
- Phase
- PHASE2
- Status
- Completed
Conditions
- Colon Cancer Stage II/III
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGLocally advanced colon cancer must be documented at screening (within 21 days prior to initiation of study treatment) and re-assessed prior surgery by spiral or multidetector computed tomography (CT) scan Postoperatively, standard adjuvant chemotherapy will be administered in pathological III-stage and at investigator discretion in pathological II-stage at high risk
Study Details
A monocentric window of opportunity study preceded by a safety run-in phase. The study population will include locally advanced colon patients (T3 or T4).
Key Dates
- Start date
- Jun 12, 2018
- Status verified
- Sep 2019
- Primary completion
- Jun 17, 2019
- Completion
- Sep 2, 2019
Study Design
- Enrollment
- 22 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: NivolumabPatients will receive nivolumab at a flat dosage of 240 mg every two weeks on Day -28 and Day-14 (+/- one day) prior to planned surgery on Day 0 or up to +7 days
Primary Outcome Measure
Tolerability and Safety [ Time Frame: "up to 5 weeks" ]