Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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 + COX2-inhibitors. This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be approximately 6 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Celecoxib; Ipilimumab; Nivolumab

Criteria

Inclusion criteria:

• Signed written informed consent

• Patients at least 18 years of age

• Stage 1-3 adenocarcinoma of the colon

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 and no history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

• 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