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

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. T...

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Other Involved Persons: Joanne Jeter
Format: eBook
Language:English
Published: Bethesda (Maryland) : ClinicalTrials.gov August 8, 2019
Item Description:Copyright: Source: ClinicalTrials.gov (no modifications made)
Copyright: ClinicalTrials.gov processed this data on December 13, 2019
Copyright: Last update posted on ClinicalTrials.gov: August 8, 2019
Copyright: Last updated: 2019-12-16
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  • 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.