RecruitingPhase 2NCT03026140

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

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)


Sponsor

The Netherlands Cancer Institute

Enrollment

353 participants

Start Date

Mar 29, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving immune checkpoint inhibitor drugs (a type of immunotherapy) before surgery can help the immune system attack early-stage colon cancer, potentially reducing the need for extensive treatment afterward. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of non-metastatic colon cancer (cancer that has not spread to other organs) - Your cancer has not caused a blockage, major bleeding, or suspected perforation of the bowel - You have not previously been treated with immunotherapy drugs - You are in good physical condition (WHO performance status 0 or 1) - You are willing to have a colonoscopy to collect tissue samples for the study **You may NOT be eligible if...** - You have an autoimmune disease (a condition where the immune system attacks the body) - You are on immune-suppressing medications such as high-dose steroids - You have active hepatitis B or C - You have had radiation therapy to the same area, or radiation is planned after surgery - You have received a live vaccine within 4 weeks of joining - You have significant heart disease or active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

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

DRUGIpilimumab

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

DRUGCelecoxib 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)

DRUGBMS-986253

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

DRUGBMS-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

View Full Details on ClinicalTrials.gov

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NCT03026140


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