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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Trial Summary
Trial Overview
Inclusion Criteria

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
Local Institution
Chicago, Illinois 60637
1730
mi
from 91732
Chicago, IL
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Local Institution
Atlanta, Georgia 30342
1918
mi
from 91732
Atlanta, GA
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Local Institution
Austin, Texas 78701
1211
mi
from 91732
Austin, TX
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Local Institution
Bakersfield, California 93301
107
mi
from 91732
Bakersfield, CA
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Local Institution
Birmingham, Alabama 35294
1785
mi
from 91732
Birmingham, AL
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Local Institution
Capital Federal, Buenos Aires
6113
mi
from 91732
Capital Federal,
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Local Institution
Charlottesville, Virginia 22908
2208
mi
from 91732
Charlottesville, VA
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Local Institution
Columbus, Ohio 43219
1965
mi
from 91732
Columbus, OH
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Local Institution
Dallas, Texas 75246
1225
mi
from 91732
Dallas, TX
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Local Institution
Durham, North Carolina 27710
2199
mi
from 91732
Durham, NC
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Local Institution
Fort Wayne, Indiana 46804
1852
mi
from 91732
Fort Wayne, IN
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Local Institution
Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
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Local Institution
Hollywood, Florida
2318
mi
from 91732
Hollywood, FL
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Local Institution
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Local Institution
Johnson City, New York 13790
2328
mi
from 91732
Johnson City, NY
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Local Institution
Lakewood, Colorado
812
mi
from 91732
Lakewood, CO
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Local Institution
Livingston, New Jersey 07039
2415
mi
from 91732
Livingston, NJ
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Local Institution
Los Angeles, California 90095
24
mi
from 91732
Los Angeles, CA
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Local Institution
Madison, Wisconsin 53792
1654
mi
from 91732
Madison, WI
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Local Institution
Minneapolis, Minnesota 55416
1505
mi
from 91732
Minneapolis, MN
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Local Institution
Niles, Illinois 60714
1722
mi
from 91732
Niles, IL
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Local Institution
Orange, California 92868
21
mi
from 91732
Orange, CA
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Local Institution
Philadelphia, Pennsylvania 19102
2375
mi
from 91732
Philadelphia, PA
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Local Institution
Portland, Oregon 97201
827
mi
from 91732
Portland, OR
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Local Institution
Rochester, Minnesota 55905
1522
mi
from 91732
Rochester, MN
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Local Institution
Saint Louis, Missouri 63104
1571
mi
from 91732
Saint Louis, MO
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Local Institution
2200 Santa Monica Boulevard
Santa Monica, California 90404
26
mi
from 91732
Santa Monica, CA
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Local Institution
10046 Church Street
Truckee, California 96161
382
mi
from 91732
Truckee, CA
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Local Institution
Tyler, Texas 75702
1314
mi
from 91732
Tyler, TX
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