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RECRUITING
NCT03026140
PHASE2

Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

353

Start Date

2017-03-29

Completion Date

2032-03-01

Last Updated

2026-03-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

Nivolumab

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

DRUG

Ipilimumab

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

DRUG

Celecoxib 200mg

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)

DRUG

BMS-986253

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

DRUG

BMS-986016

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

Locations (6)

Marieke van de Belt

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Spaarne Ziekenhuis

Haarlem, Netherlands

Tergooi

Hilversum, Netherlands

Haga ziekenhuis

The Hague, Netherlands