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

Launched by THE NETHERLANDS CANCER INSTITUTE · Jan 19, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with early-stage colon cancer, specifically those with stage 1-3 adenocarcinoma that has not spread to other parts of the body. The researchers want to see how well short-term immunotherapy works, along with some new combinations of treatments, before the patients undergo surgery to remove their tumors. Participants will receive this treatment for about six weeks.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with non-metastatic adenocarcinoma of the colon. They should not have any signs of the cancer spreading, and they need to undergo a colonoscopy to collect specific biopsies for the study. Individuals with certain health conditions, such as autoimmune diseases or a history of severe allergic reactions to the study drugs, will not be able to participate. If eligible, participants can expect close monitoring and care during the treatment period, which aims to enhance their chances of a successful surgery.

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Eligibility criteria

• 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