CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 353 target
Drug / intervention
Nivolumab +4 moredrug
Likely dose
Celecoxib 200mgfrom record
Key inclusion· 4
  • ✓Age at least 18 years
  • ✓Non-metastatic adenocarcinoma of the colon (rectosigmoid included, not undergoing neoadjuvant treatment)
  • ✓No distant metastases on imaging and physical exam
  • ✓For dMMR cohorts: >cT3 and/or N+
Key exclusion· 11
  • ✕Signs of obstruction, macroscopic bleeding, or suspicion of perforation
  • ✕Prior treatment with CTLA-4, PD-1, or PD-L1 checkpoint inhibitors
  • ✕For MSS tumors: current use of NSAIDs or COX2-inhibitors, or active peptic ulcer, GI bleeding, unstable ischemic heart disease, significant established ischemic heart disease, peripheral arterial disease, or cerebrovascular disease
  • ✕Prior or planned post-surgery radiotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03026140
NCT03026140Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
CompareCT.gov

Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)

The Netherlands Cancer Institute·interventional·Posted Jan 20, 2017·Updated Mar 5, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 3 other interventions for Colon Carcinoma. Currently recruiting, targeting 353 participants across 6 sites.

Detailed Summary

In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors, anti-LAG3). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be in between approximately 6 and 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Carcinoma
CountriesNetherlands
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2Recruiting
2017201820192020202120222023202420252026202720282029203020312032
First PostedJan 20, 2017
Enrollment StartMar 29, 2017
Primary CompletionMar 1, 2032
TodayJul 2, 2026
Enrollment to primary: 14.9 yearsPosted 9.5 years agoPrimary completion in 5.7 years

Interventions

Nivolumabdrug

Nivolumab 3mg/kg (day 1 and day 15), administered neoadjuvant before surgery

Ipilimumabdrug

Ipilimumab 1 mg/kg (day 1) ,administered neoadjuvant before surgery

Celecoxib 200mgdrug

celecoxib will be administered starting day 1 until 1 day before surgery daily (if patient is randomized to group 2 (only applicable for patients with a MSS tumor)

BMS-986253drug

BMS-986253 2400mg IV will be administered on day 1 and 15 (only applicable for patients with MSS tumors)

BMS-986016drug

Relatlimab will be administered IV, in cohort 5 240mg on day 1 and day 15, in cohort 6 480mg on day 1 and day 29, in cohort 7 160mg on day 1, day 29 and day 57