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

NCT03026140 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Colon Carcinoma

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

Sponsors & Collaborators

Principal Investigators

  • Myriam Chalabi, MD · Antoni van Leeuwenhoek

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2032-03-01
Completion
2032-03-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03026140 on ClinicalTrials.gov