Study of Nivolumab for Advanced Cancers in India

Overview

This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.

Full Title of Study: “Safety Study of Nivolumab for Selected Advanced Malignancies in India”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 17, 2019

Interventions

  • Drug: Nivolumab
    • specified dose on specified days

Arms, Groups and Cohorts

  • Experimental: Monotherapy
    • administering nivolumab only

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Treatment-related Adverse Events
    • Time Frame: 26 Weeks
    • Number of participants with treatment-related Adverse Events based on worst ctc grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.

Secondary Measures

  • Number of Participants With Treatment-related Select Adverse Events
    • Time Frame: 26 Weeks
    • Number of participants with treatment-related Select Adverse Events based on worst ctc grade for the following categories: Pulmonary, Gastrointestinal, Endocrinopathies, Hepatic, Renal, Skin, Neurological and Hypersensitivity/Infusion reactions Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
  • Number of Participants With Treatment-related Serious Adverse Events
    • Time Frame: 26 Weeks
    • Number of participants with treatment-related Serious Adverse Events based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
  • Number of Participants With Adverse Events Leading to Discontinuation
    • Time Frame: 26 Weeks
    • Number of participants with Adverse events leading to discontinuation of treatment based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.

Participating in This Clinical Trial

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:

  • Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy – Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 – Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization Exclusion Criteria:

  • Participants with untreated, symptomatic central nervous system (CNS) metastases – Participants with carcinomatous meningitis – Participants with active, known or suspected autoimmune disease – Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications – Other active malignancy requiring concurrent intervention Other protocol defined inclusion/exclusion criteria could apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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