Short-term immunotherapy for early-stage colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory study aims to treat patients with stage 1-3 adenocarcinoma of the colon using short-term immunotherapy combined with novel immune-oncology agents before surgical resection. The study will enroll 100 patients, including those with microsatellite stable (MSS) and microsatellite instability (MSI) tumors, and will evaluate the effectiveness of various treatment combinations over approximately six weeks. Patients will receive either nivolumab and ipilimumab alone or in combination with other agents like celecoxib or anti-IL8. The primary endpoint is to assess the 3-year disease-free survival for the MSI cohort.

Why it matters

Who can join: the full rules

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

Where it's running

• Marieke van de Belt
  Amsterdam, Netherlands Recruiting
• Olvg
  Amsterdam, Netherlands Recruiting
• Catharina Ziekenhuis
  Eindhoven, Netherlands Recruiting
• Spaarne Ziekenhuis
  Haarlem, Netherlands Recruiting
• Tergooi
  Hilversum, Netherlands Not yet recruiting
• Haga ziekenhuis
  The Hague, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Myriam Chalabi, MD — Antoni van Leeuwenhoek
• Study coordinator: Marieke van de Belt
• Email: m.vd.belt@nki.nl
• Phone: +3120512

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.