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A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer (CHECKMATE 920)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02982954
Recruitment Status : Active, not recruiting
First Posted : December 6, 2016
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Nivolumab Drug: Ipilimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 7, 2016
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ccRCC KPS ≥ 70%
Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
Drug: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose on Specified Day
Other Names:
  • Yervoy
  • BMS-734016

Experimental: Non-ccRCC, KPS ≥ 70%
Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
Drug: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose on Specified Day
Other Names:
  • Yervoy
  • BMS-734016

Experimental: RCC with non-active Brain Mets, KPS ≥70%
Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
Drug: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose on Specified Day
Other Names:
  • Yervoy
  • BMS-734016

Experimental: any RCC with KPS 50%-60%
Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%
Drug: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose on Specified Day
Other Names:
  • Yervoy
  • BMS-734016




Primary Outcome Measures :
  1. Incidence of high grade immune-mediated adverse events (IMAEs) [ Time Frame: Approximately 3 months ]
    high grade IMAEs: Common Terminology Criteria for Adverse Events (CTCAE) version 4 Grade 3-4 and Grade 5 IMAEs


Secondary Outcome Measures :
  1. Time to onset of all high grade IMAEs [ Time Frame: Approximately 3 months ]
  2. Time to resolution of all high grade IMAEs [ Time Frame: Approximately 48 months ]
  3. Percentage of patients who received immune modulating medication due to high grade IMAEs [ Time Frame: Approximately 48 months ]
  4. Progression-free survival at time of initial progression (PFS 1) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as assessed by the investigator [ Time Frame: Approximately 48 months ]
  5. Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as assessed by the investigator [ Time Frame: Approximately 48 months ]
  6. Time to response (TTR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as assessed by the investigator [ Time Frame: Approximately 48 months ]
  7. Duration of response (DOR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as assessed by the investigator [ Time Frame: Approximately 48 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982954


  Hide Study Locations
Locations
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United States, Alabama
Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, United States, 35661
United States, Alaska
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States, 99503
United States, Arizona
Ironwood Cancer And Research Centers, Pc
Chandler, Arizona, United States, 85224
United States, Arkansas
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, United States, 72703
United States, California
eCare
Encinitas, California, United States, 92024
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Los Angeles Cancer Network
Los Angeles, California, United States, 90017
UCLA Hematology Oncology
Los Angeles, California, United States, 90095-6984
Torrance Health Association
Redondo Beach, California, United States, 90277
Kaiser Permanente Medical Group - Southern California
Riverside, California, United States, 92505
Sharp Memorial Hospital
San Diego, California, United States, 92123
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Central Coast Med Oncology
Santa Maria, California, United States, 93454
United States, Florida
Florida Cancer Specialists S.
Fort Myers, Florida, United States, 33901
University Of Miami/Sylvester Cancer Center
Miami, Florida, United States, 33136
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
United States, Indiana
Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana, United States, 46845
United States, Kansas
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Minnesota
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States, 55404
Southdale Cancer Clinic
Minneapolis, Minnesota, United States, 55435
Park Nicollet Clinic Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States, 39202
United States, Missouri
HCA Midwest Division
Kansas City, Missouri, United States, 64132
United States, Nebraska
St. Francis Cancer Treatment Center
Grand Island, Nebraska, United States, 68803
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
United States, New Jersey
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University Of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Maimonides Medical Center
Brooklyn, New York, United States, 11220
Broome Oncology
Johnson City, New York, United States, 13790
Laura & Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10021
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Va Medical Center Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
United States, South Carolina
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States, 29414
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
Texas Oncology
Austin, Texas, United States, 78731
Texas Oncology
Dallas, Texas, United States, 75246
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, United States, 76104
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, United States, 79701
Texas Oncology
San Antonio, Texas, United States, 78217
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22936
Inova Research Center
Fairfax, Virginia, United States, 22031
Bon Secours St Francis Hospital
Midlothian, Virginia, United States, 23114
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Medical Oncology Associates
Spokane, Washington, United States, 99208
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
United States, Wisconsin
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02982954     History of Changes
Other Study ID Numbers: CA209-920
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents