A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
NCT ID: NCT02982954
Last Updated: 2022-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
211 participants
INTERVENTIONAL
2017-01-16
2021-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ccRCC KPS ≥ 70%
Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
Nivolumab
Specified dose on specified day
Ipilimumab
Specified Dose on Specified Day
Non-ccRCC, KPS ≥ 70%
Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
Nivolumab
Specified dose on specified day
Ipilimumab
Specified Dose on Specified Day
RCC with non-active Brain Mets, KPS ≥70%
Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
Nivolumab
Specified dose on specified day
Ipilimumab
Specified Dose on Specified Day
any RCC with KPS 50%-60%
Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%
Nivolumab
Specified dose on specified day
Ipilimumab
Specified Dose on Specified Day
Interventions
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Nivolumab
Specified dose on specified day
Ipilimumab
Specified Dose on Specified Day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States
Ironwood Cancer And Research Centers, Pc
Chandler, Arizona, United States
Local Institution - 0028
Fayetteville, Arkansas, United States
eCare
Encinitas, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
UCLA Hematology Oncology
Los Angeles, California, United States
Torrance Health Association
Redondo Beach, California, United States
Kaiser Permanente Medical Group - Southern California
Riverside, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Central Coast Med Oncology
Santa Maria, California, United States
Florida Cancer Specialists S.
Fort Myers, Florida, United States
University Of Miami/Sylvester Cancer Center
Miami, Florida, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Local Institution - 0012
Fort Wayne, Indiana, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Southdale Cancer Clinic
Burnsville, Minnesota, United States
Local Institution - 0009
Coon Rapids, Minnesota, United States
Park Nicollet Clinic Cancer Center
Minneapolis, Minnesota, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States
HCA Midwest Division
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Local Institution - 0023
Hackensack, New Jersey, United States
University Of New Mexico
Albuquerque, New Mexico, United States
Maimonides Medical Center
Brooklyn, New York, United States
St. Francis Cancer Treatment Center
Grand Island, New York, United States
Broome Oncology
Johnson City, New York, United States
Local Institution - 0052
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
Tulsa, Oklahoma, United States
Local Institution - 0071
Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Chattanooga, Tennessee, United States
Local Institution - 0002
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology
Austin, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, United States
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, United States
Texas Oncology
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Local Institution - 0042
Fairfax, Virginia, United States
Bon Secours St Francis Hospital
Midlothian, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Medical Oncology Associates
Spokane, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Countries
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References
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George DJ, Spigel DR, Gordan LN, Kochuparambil ST, Molina AM, Yorio J, Rezazadeh Kalebasty A, McKean H, Tchekmedyian N, Tykodi SS, Zhang J, Askelson M, Johansen JL, Hutson TE. Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial. BMJ Open. 2022 Sep 14;12(9):e058396. doi: 10.1136/bmjopen-2021-058396.
Tykodi SS, Gordan LN, Alter RS, Arrowsmith E, Harrison MR, Percent I, Singal R, Van Veldhuizen P, George DJ, Hutson T, Zhang J, Zoco J, Johansen JL, Rezazadeh Kalebasty A. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial. J Immunother Cancer. 2022 Feb;10(2):e003844. doi: 10.1136/jitc-2021-003844.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-920
Identifier Type: -
Identifier Source: org_study_id
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