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. Identifier: NCT02596035
Recruitment Status : Active, not recruiting
First Posted : November 4, 2015
Last Update Posted : November 1, 2018
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
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 : November 30, 2015
Actual Primary Completion Date : May 1, 2018
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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

Primary Outcome Measures :
  1. Incidence of high grade (Grade 3-4 and Grade 5) IMAEs in subjects with advanced or metastatic renal cell carcinoma (RCC) who are treated with nivolumab monotherapy [ Time Frame: Approximately 2 years ]
    IMAEs: skin, endocrinopathy, gastrointestinal, hepatic, renal, pulmonary and hypersensitivity reactions

Secondary Outcome Measures :
  1. Median time to onset of high grade (Grade 3-4) IMAEs [ Time Frame: Approximately 2 years ]
    Median time to onset: Time to onset is calculated from first dosing date to the event onset date

  2. Median time to resolution of high grade (Grade 3-4) IMAEs [ Time Frame: Approximately 2 years ]
    Median time to resolution: Time to resolution is calculated from the adverse events (AE) onset date to AE end date

  3. Percentage of subjects who receive immune modulating medication for the immune-mediated event [ Time Frame: Approximately 2 years ]
    Immune modulating medication: corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil

  4. Percentage of subjects who receive hormonal replacement therapy for the immune-mediated event [ Time Frame: Approximately 2 years ]
  5. Percentage of subjects who receive ≥ 40 mg prednisone equivalents for the immune-mediated event [ Time Frame: Approximately 2 years ]
  6. Total duration of all immune modulating medications given for the immune-mediated event [ Time Frame: Approximately 2 years ]

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

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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

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 identifier (NCT number): NCT02596035

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Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT02596035     History of Changes
Other Study ID Numbers: CA209-374
2015-003286-28 ( EudraCT Number )
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs