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

NCT03631641 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-07-01

Study results available
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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.

Conditions

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

Interventions

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

Principal Investigators

  • John Hays, MD, Ph.D · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2021-01-25
Completion
2021-01-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631641 on ClinicalTrials.gov