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An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374)

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: NCT02596035
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : August 28, 2019
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)
Actual Study Start Date : January 8, 2016
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : May 24, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab dose as specified
 Drug: Nivolumab
Other Name: Opdivo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) [ Time Frame: Up to 100 days of the last dose of study drug (Approximately 2 years) ]
    IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.


Secondary Outcome Measures :
  1. Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events [ Time Frame: Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months) ]
    Time to onset was calculated from first dosing date to the event onset date. If a participant never experienced the given AE, the participant will be censored at the last contact date.

  2. Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events [ Time Frame: From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months) ]
    Time-to resolution of grade 3-5 AE was defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered select AEs in the category experienced by the participant. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known date alive.

  3. Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade) [ Time Frame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months) ]
    Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil

  4. Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event [ Time Frame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months) ]
    Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil

  5. Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event [ Time Frame: From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).) ]
    Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil.

  6. Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication [ Time Frame: Up to 100 days of the last dose of study drug (Approximately 2 years) ]
    Percentage of participants with a resolution of IMAEs after initiating immune modulating medication.


Eligibility Criteria
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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

Inclusion Criteria:

  • Advanced or Metastatic renal cell carcinoma (RCC)

  • Predominant clear cell histology:

    1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
    2. No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
    3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
  • Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
  • Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
  • Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
  • All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed

Exclusion Criteria:

  • Subjects with any active autoimmune disease or a history of known autoimmune disease
  • History of severe hypersensitivity reaction to other monoclonal antibodies
  • Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
  • Known HIV or AIDS-related illness
  • Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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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): NCT02596035


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] October 31, 2016
Statistical Analysis Plan  [PDF] September 9, 2016

More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02596035    
Other Study ID Numbers: CA209-374
2015-003286-28 ( EudraCT Number )
First Posted: November 4, 2015    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: October 27, 2022
Last Verified: October 2022

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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
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action