Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy
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|ClinicalTrials.gov Identifier: NCT03631641|
Recruitment Status : Suspended (sponsor decision)
First Posted : August 15, 2018
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Adenoma Colon Carcinoma Lynch Syndrome MLH1 Gene Mutation MSH2 Gene Mutation||Biological: Nivolumab||Phase 2|
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.
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.
I. To determine biomarkers of immunologic activity associated with biologic activity of nivolumab in this population.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 21, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Treatment (nivolumab)
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.
- Incidence rate of adenomas [ Time Frame: At 3 years ]The associated confidence intervals will be reported and used to determine if the incidence rate is significantly different from that reported among Lynch patients not receiving nivolumab, 0.33.
- Incidence rate of high-risk adenomas [ Time Frame: At 3 years ]The associated confidence interval will be reported and used to determine if the incidence rate is significantly different from 0.22, the reported incidence of high-risk adenomas among Lynch syndrome patients not receiving nivolumab.
- Incidence rate of colon cancers [ Time Frame: At 3 years ]The incidence rates of colon cancers in Lynch patients treated with nivolumab will be estimated with corresponding confidence intervals.
- Incidence rate of non-colonic cancers [ Time Frame: At 3 years ]The incidence rates of non-colonic cancers in Lynch patients treated with nivolumab will be estimated with corresponding confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631641
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Joanne Jeter, MD, MS||Ohio State University Comprehensive Cancer Center|