IRB #

STUDY00018788

Title

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the combination of two investigational drugs called nivolumab and ipilimumab, or nivolumab alone, in participants with solid tumors who have high tumor mutational burden (TMB-H).

Medical Condition(s)

Advanced or Metastatic Solid Tumors
High Tumor Burden Mutation
TMB-H

Eligibility Criteria

1. Men and women 18 years or older
2. Locally advanced or metastatic solid tumors
3. Adequate organ function
4. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drugs for up to 24 months or until your disease worsens, you experience unacceptable side effects, or you withdraw your consent to participate in the study. After you finish the study intervention, the investigator will continue to watch you for side effects and follow your condition every 3 months indefinitely or until you withdraw consent.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Bristol-Myers Squibb

Recruitment End

02/15/2020

Compensation Provided

No


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