Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 104
Summary
- Conditions
- Colon Adenoma
- Colon Carcinoma
- Lynch Syndrome
- MLH1 Gene Mutation
- MSH2 Gene Mutation
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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. T...
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.
Tracking Information
- NCT #
- NCT03631641
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Joanne Jeter, MD, MS Ohio State University Comprehensive Cancer Center