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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

Tracking Information
First Submitted Date  ICMJE December 2, 2016
First Posted Date  ICMJE December 6, 2016
Last Update Posted Date January 3, 2019
Actual Study Start Date  ICMJE December 7, 2016
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02982954 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • Time to onset of all high grade IMAEs [ Time Frame: Approximately 3 months ]
  • Time to resolution of all high grade IMAEs [ Time Frame: Approximately 48 months ]
  • Percentage of patients who received immune modulating medication due to high grade IMAEs [ Time Frame: Approximately 48 months ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
  • Time to onset of all high grade IMAEs [ Time Frame: Approximately 3 months ]
  • Time to resolution of all high grade IMAEs [ Time Frame: Approximately 48 months ]
  • Percentage of patients who received immune modulating medication due to high grade IMAEs [ Time Frame: Approximately 48 months ]
  • Progression-free survival at time of initial progression (PFS 1) [ Time Frame: Approximately 48 months ]
  • Objective response rate (ORR) [ Time Frame: Approximately 48 months ]
  • Time to response (TTR) [ Time Frame: Approximately 48 months ]
  • Duration of response (DOR) [ Time Frame: Approximately 48 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
Official Title  ICMJE 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)
Brief Summary To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Nivolumab
    Specified dose on specified day
    Other Names:
    • BMS-936558
    • Opdivo
  • Drug: Ipilimumab
    Specified Dose on Specified Day
    Other Names:
    • Yervoy
    • BMS-734016
Study Arms  ICMJE
  • Experimental: ccRCC KPS ≥ 70%
    Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Experimental: Non-ccRCC, KPS ≥ 70%
    Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Experimental: RCC with non-active Brain Mets, KPS ≥70%
    Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • 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%
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02982954
Other Study ID Numbers  ICMJE CA209-920
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP