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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
John Hays
Study ID
NCT03631641
Phase
PHASE2
Status
Terminated

Conditions

  • Colon Adenoma
  • Colon Carcinoma
  • Lynch Syndrome
  • MLH1 Gene Mutation
  • MSH2 Gene Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 4, 2018
Status verified
Jun 2024
Primary completion
Jan 25, 2021
Completion
Jan 25, 2021

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Incidence Rate of Adenomas [ Time Frame: At 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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