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Completed

NCT Number: NCT02596035

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

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution - 0030, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced or Metastatic renal cell carcinoma (RCC)
  • Predominant clear cell histology:
  • At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
  • No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
  • 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

Treatment and study plan

Nivolumab

Drug

Other names: Opdivo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Acronym: CheckMate 374

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Nov 4, 2015
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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