A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)



Status:Recruiting
Healthy:No
Age Range:12 - Any
Updated:3/9/2019
Start Date:October 29, 2018
End Date:September 8, 2023
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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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)

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab
alone is effective and safe in the treatment of solid tumors with High Tumor Mutational
Burden (TMB-H)


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Participants with a refractory, metastatic, or unresectable histologically or
cytologically confirmed solid malignant tumor with TMB-H who are refractory to
standard local therapies, or for which no standard treatment is available.

- Available tumor tissue and blood for TMB testing

- Participants must have measurable disease for response assessment

Exclusion Criteria:

- Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma
(RCC) or hematological malignancy as primary site of disease

- Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically
targeting T-cell co-stimulation or checkpoint pathways

- Treatment with any chemotherapy, radiation therapy, biologics for cancer, or
investigational therapy within 28 days of first administration of study treatment

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
29
sites
Los Angeles, California 90095
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Atlanta, Georgia 30342
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Atlanta, GA
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Austin, Texas 78701
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Austin, TX
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Bakersfield, California 93301
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Bakersfield, CA
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Birmingham, Alabama 35294
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Birmingham, AL
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Capital Federal, Buenos Aires
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Capital Federal,
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Charlottesville, Virginia 22908
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Charlottesville, VA
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Chicago, Illinois 60637
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Chicago, IL
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Columbus, Ohio 43219
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Columbus, OH
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Dallas, Texas 75246
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Dallas, TX
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Durham, North Carolina 27710
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Durham, NC
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Fort Wayne, Indiana 46804
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Fort Wayne, IN
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Germantown, Tennessee 38138
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Germantown, TN
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Hollywood, Florida
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Hollywood, FL
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Houston, Texas 77030
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Houston, TX
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Johnson City, New York 13790
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Johnson City, NY
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Lakewood, Colorado
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Lakewood, CO
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Livingston, New Jersey 07039
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Livingston, NJ
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Madison, Wisconsin 53792
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Madison, WI
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Minneapolis, Minnesota 55416
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Minneapolis, MN
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Niles, Illinois 60714
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Niles, IL
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Orange, California 92868
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Orange, CA
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Portland, Oregon 97201
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Portland, OR
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, Missouri 63104
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Saint Louis, MO
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2200 Santa Monica Boulevard
Santa Monica, California 90404
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Santa Monica, CA
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10046 Church Street
Truckee, California 96161
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Truckee, CA
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Tyler, Texas 75702
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Tyler, TX
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