A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:December 7, 2016
End Date:February 28, 2023

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Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with
previously untreated advanced or metastatic Renal Cell Cancer.


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

Inclusion Criteria:

1. Type of Participant and Target Disease Characteristics

1. Advanced or metastatic RCC

2. Histologically confirmed, previously untreated (treatment-naive) RCC

3. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy
for completely resectable RCC

4. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as
measurable disease

5. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of
50-60% for Cohort 4

6. Tumor tissue need be received by the central vendor (block or unstained slides). Note:
Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for
submission.

Exclusion Criteria:

1. Medical Conditions

1. Subjects with any active autoimmune disease or a history of known autoimmune
disease

2. Prior malignancy active within the previous 3 years except for locally curable
cancers that have been apparently cured

3. Known HIV or AIDS-related illness

4. Any positive test for hepatitis B or hepatitis C virus indicating acute or
chronic infection.

2. Prior/Concomitant Therapy

1. Prior systemic treatment in the metastatic setting with Vascular epithelial
growth factor(VEGF) or VEGF receptor targeted therapy

2. Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2,
anti-cluster of differentiation 137 (CD137), or anti-cytotoxic
T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways. This
includes the utilization of these agents in the neo-adjuvant or adjuvant setting.

3. Anti-cancer therapy less than 28 days prior to the first dose of study drug or
palliative, focal radiation therapy less than 14 days prior to the first dose of
study drug.

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
61
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
484
mi
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Bronx, NY
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
333
mi
from 43215
Nashville, TN
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
2006
mi
from 43215
Seattle, WA
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
746
mi
from 43215
Sioux Falls, SD
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
1335
mi
from 43215
Albuquerque, NM
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Anchorage, Alaska 99503
Phone: 907-276-1455
3104
mi
from 43215
Anchorage, AK
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432
mi
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Atlanta, GA
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Austin, Texas 78731
1062
mi
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Austin, TX
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
477
mi
from 43215
Brooklyn, NY
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Chandler, Arizona 85224
1655
mi
from 43215
Chandler, AZ
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Charleston, South Carolina 29403
523
mi
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Charleston, SC
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Charleston, South Carolina 29425
524
mi
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Charleston, SC
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
275
mi
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Charlottesville, VA
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Chattanooga, Tennessee 37404
362
mi
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Chattanooga, TN
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Dallas, Texas 75246
909
mi
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Dallas, TX
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
352
mi
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Durham, NC
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Encinitas, California 92024
1949
mi
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Encinitas, CA
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3225 Gallows Road
Fairfax, Virginia 22031
318
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Fairfax, VA
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Fayetteville, Arkansas 72703
659
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Fayetteville, AR
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Fort Myers, Florida 33916
924
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Fort Myers, FL
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Fort Wayne, Indiana 46845
139
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Fort Wayne, IN
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Fort Worth, Texas 76104
937
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Fort Worth, TX
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Goldsboro, North Carolina 27534
422
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Goldsboro, NC
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Grand Island, Nebraska 68803
834
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Grand Island, NE
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Hackensack, New Jersey 07601
476
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Hackensack, NJ
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Hattiesburg, Mississippi 39401
694
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Hattiesburg, MS
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Jackson, Mississippi 39202
661
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Jackson, MS
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Johnson City, New York 13790
396
mi
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Johnson City, NY
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Kansas City, Missouri 64132
618
mi
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Kansas City, MO
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
1767
mi
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Las Vegas, NV
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Long Beach, California 90813
1976
mi
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Long Beach, CA
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Los Angeles, California 90095
Phone: 310-267-8522
1982
mi
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Los Angeles, CA
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201 South Alvarado Street
Los Angeles, California 90017
1973
mi
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Los Angeles, CA
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Louisville, Kentucky 40207
183
mi
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Louisville, KY
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392
mi
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Madison, WI
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996
mi
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Miami, FL
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1195
mi
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Midland, TX
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13710 Saint Francis Boulevard
Midlothian, Virginia 23114
336
mi
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Midlothian, VA
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Minneapolis, Minnesota 55405
627
mi
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Minneapolis, MN
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6363 France Avenue South
Minneapolis, Minnesota 55435
625
mi
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Minneapolis, MN
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Muscle Shoals, Alabama 35661
439
mi
from 43215
Muscle Shoals, AL
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
348
mi
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Nashville, TN
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New York, New York 10021
480
mi
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New York, NY
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New York, New York 10016
478
mi
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New York, NY
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Niles, Illinois 60714
286
mi
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Niles, IL
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797
mi
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Orlando, FL
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4100 Allequippa Street
Pittsburgh, Pennsylvania 15240
164
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Pittsburgh, PA
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Redondo Beach, California 90277
1985
mi
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Redondo Beach, CA
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Richmond, Virginia 23235
338
mi
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Richmond, VA
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10800 Magnolia Avenue
Riverside, California 92505
1935
mi
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Riverside, CA
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Saint Louis Park, Minnesota 55416
627
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Saint Louis Park, MN
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Saint Petersburg, Florida 33705
845
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Saint Petersburg, FL
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San Antonio, Texas 78217
1129
mi
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San Antonio, TX
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
1947
mi
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San Diego, CA
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San Luis Obispo, California 93401
2069
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San Luis Obispo, CA
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Santa Maria, California 93454
2065
mi
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Santa Maria, CA
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Spokane, Washington 99208
1780
mi
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Spokane, WA
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750 East Adams Street
Syracuse, New York 13210
414
mi
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Syracuse, NY
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746
mi
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Tulsa, OK
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
784
mi
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Wichita, KS
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2811 Tieton Drive
Yakima, Washington 98902
1922
mi
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Yakima, WA
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