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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)

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ClinicalTrials.gov Identifier: NCT02982954
Recruitment Status : Active, not recruiting
First Posted : December 6, 2016
Last Update Posted : July 18, 2018
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

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


  Show 61 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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: July 18, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs