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

October 6, 2022 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35661
        • Northwest Alabama Cancer Center, Pc
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Urological Institute dba Alaska Clinical Research Center
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer And Research Centers, Pc
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Local Institution - 0028
    • California
      • Encinitas, California, United States, 92024
        • eCare
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90095
        • UCLA Hematology Oncology
      • Los Angeles, California, United States, 90017
        • Los Angeles Cancer Network
      • Redondo Beach, California, United States, 90277
        • Torrance Health Association
      • Riverside, California, United States, 92505
        • Kaiser Permanente Medical Group - Southern California
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Luis Obispo, California, United States, 93401
        • Coastal Integrative Cancer Care
      • Santa Maria, California, United States, 93454
        • Central Coast Med Oncology
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists S.
      • Miami, Florida, United States, 33136
        • University of Miami/Sylvester Cancer Center
      • Orlando, Florida, United States, 32806
        • UF Health Cancer Center at Orlando Health
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University - Winship Cancer Institute
    • Illinois
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Local Institution - 0012
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Southdale Cancer Clinic
      • Coon Rapids, Minnesota, United States, 55433
        • Local Institution - 0009
      • Minneapolis, Minnesota, United States, 55416
        • Park Nicollet Clinic Cancer Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • HCA Midwest Division
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0023
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11220
        • Maimonides Medical Center
      • Grand Island, New York, United States, 68803
        • St. Francis Cancer Treatment Center
      • Johnson City, New York, United States, 13790
        • Broome Oncology
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • New York, New York, United States, 10016
        • Local Institution - 0052
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • Local Institution - 0071
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates, PA
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology, PLLC - SCRI - PPDS
      • Nashville, Tennessee, United States, 37232-6307
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203-1624
        • Local Institution - 0002
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology
      • Dallas, Texas, United States, 75246
        • Texas Oncology
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology-Fort Worth 12th Ave
      • Midland, Texas, United States, 79701
        • Texas Oncology-Midland Allison Cancer Center
      • San Antonio, Texas, United States, 78217
        • Texas Oncology
    • Virginia
      • Charlottesville, Virginia, United States, 22936
        • University of Virginia Health System
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 0042
      • Midlothian, Virginia, United States, 23114
        • Bon Secours St Francis Hospital
      • Richmond, Virginia, United States, 23226
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington - Seattle Cancer Care Alliance
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital/North Star Lodge
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University Of Wisconsin Clinical Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • BMS-734016
  • Yervoy
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:
  • BMS-734016
  • Yervoy
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:
  • BMS-734016
  • Yervoy
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:
  • BMS-734016
  • Yervoy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
Time Frame: Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Approximately 39 Months
Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)
Time Frame: Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Approximately 39 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
Time Frame: From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)
Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)
Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
Time Frame: From the IMAE onset date to the IMAE end date, up to approximately 194 weeks
Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
From the IMAE onset date to the IMAE end date, up to approximately 194 weeks
Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
Time Frame: From first dose up to 100 days post last dose (up to approximately 29 months)
The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
Time Frame: From first dose up to 100 days post last dose (up to approximately 29 months)
The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
Time Frame: From first dose up to 100 days post last dose (up to approximately 29 months)
The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
From first dose up to 100 days post last dose (up to approximately 29 months)
Median Progression Free Survival (PFS)
Time Frame: From first dose to the date of the first documented progressive disease, up to approximately 12 months
PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From first dose to the date of the first documented progressive disease, up to approximately 12 months
Objective Response Rate (ORR)
Time Frame: From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)
Time to Response Rate (TRR)
Time Frame: From the date of first dose to first documented CR or PR, up to approximately 15 months
TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
From the date of first dose to first documented CR or PR, up to approximately 15 months
Duration of Response (DOR)
Time Frame: From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months
DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2017

Primary Completion (Actual)

May 11, 2020

Study Completion (Actual)

October 6, 2021

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-920

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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