Immunotherapy before surgery shows promise for early colon cancer
NCT ID NCT03026140
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether giving a short course of immunotherapy drugs before surgery can improve outcomes for people with early-stage colon cancer. Participants will receive a combination of nivolumab, ipilimumab, and possibly other drugs for about 6 to 12 weeks before their tumor is removed. The goal is to see if this approach is safe and can reduce the chance of the cancer coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab, ipilimumab, celecoxib, and BMS-986253 (anti-IL8)
- What this could lead to
- If successful, this could lead to a new standard of care using short-term immunotherapy before surgery to reduce the risk of cancer returning in early-stage colon cancer patients.
- What could go wrong
- This is an early-phase exploratory trial with a small number of participants, so results may not apply to all patients. Immunotherapy can cause serious side effects like inflammation of organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 353 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2017
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Catharina Ziekenhuis
RECRUITINGEindhoven, Netherlands
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Haga ziekenhuis
NOT_YET_RECRUITINGThe Hague, Netherlands
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Marieke van de Belt
RECRUITINGAmsterdam, 1066CX, Netherlands
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OLVG
RECRUITINGAmsterdam, Netherlands
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Spaarne Ziekenhuis
RECRUITINGHaarlem, Netherlands
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Tergooi
NOT_YET_RECRUITINGHilversum, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New injectable drug tested against Hard-to-Treat solid tumors
- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells
- Blood test may spot colon cancer return months before scans
- Can a probiotic shield patients from Post-Surgery infections?