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

Official record

Identifier

NCT03026140

Recruiting locations

country

Netherlands

Interventions studied

NivolumabIpilimumabCelecoxib 200mgBMS-986253Relatlimab (BMS-986016)

Lead sponsor

The Netherlands Cancer Institute

Target enrolment

353 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Jan 20, 2017

Last updated on the registry

Sep 30, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion criteria:

* Signed written informed consent
* Patients at least 18 years of age
* Non-metastatic adenocarcinoma of the colon (and rectosigmoid considered as nonrectal and not undergoing neoadjuvant treatment)

  * No signs of distant metastases on CT-scan and physical examination;
  * dMMR cohorts 3+6: \>cT3 and/or N+

Exclusion criteria:

* No signs of distant metastases
* No signs of obstruction or macroscopic bleeding or suspicion of perforation
* Colonoscopy must be performed after registration to obtain study-specific biopsies. If biopsies are not possible, patients cannot be included in the study
* WHO performance status of 0 or 1
* No previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1
* For patients with MSS tumors: no current use of NSAIDs or COX2-inhibitors at registration and no active peptic ulcer, gastrointestinal bleeding, unstable ischemic heart disease of thrombus etiology or significant established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease
* No radiotherapy prior to or planned post-surgery radiotherapy
* No history of allergy to study drug components, severe hypersensitivity reaction to any monoclonal antibody, allergy or severe hypersensitivity to NSAIDs or COX2-I (MSS tumors)
* No intercurrent illnesses, including but not limited to infections, unstable angina pectoris
* No positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* No autoimmune disease
* No conditions requiring systemic treatment with either corticosteroids (10 mg daily prednisone or more and equivalents) or other immunosuppressive medications within 14 days of study drug administration
* No live vaccines in the 4 weeks prior to inclusion

Indexed under

Colorectal Cancer