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Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy

Lynch Syndrome Clinical Trial

Official title:
A Phase II Study of PD-1 Inhibition for the Prevention of Colon Adenomas in Patients With Lynch Syndrome and a History of Partial Colectomy

Clinical Trial Summary

This phase II trial studies how well nivolumab works in preventing colon adenomas in participants with Lynch syndrome and a history of surgery to remove part of the colon. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine if maintenance therapy with nivolumab can decrease the incidence of colon adenomas in a population of patients with genetic predisposition to colorectal cancer and a history of hemicolectomy due to colon cancer or advanced colon adenoma.

SECONDARY OBJECTIVES:

I. To assess the safety of nivolumab maintenance therapy in this population. II. To obtain preliminary data on the short-term incidence of advanced colon adenomas (measuring greater than 10 mm or with high-grade dysplasia) and colon and non-colonic cancers in Lynch patients treated with maintenance nivolumab.

EXPLORATORY OBJECTIVES:

I. To determine biomarkers of immunologic activity associated with biologic activity of nivolumab in this population.

OUTLINE:

Participants receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 3 months for a total of 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 3 months, every 6 months for 1 year, then every 12 weeks thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03631641
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 21, 2018
Completion date December 31, 2020
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