Study of Nivolumab for Advanced Cancers in India

Phase 4CompletedNCT03444766

Bristol-Myers Squibb100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Non-Small Cell Lung Cancer (NSCLC)Non-Small-Cell Lung Carcinoma Nonsmall Cell Lung Cancer Kidney Cancer Kidney Neoplasms Renal Cancer Renal Neoplasms

Interventions

NivolumabDRUG

specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Local Institution

Bangalore, India

Local Institution

Bangalore, India

Local Institution

Bengaluru, India

Local Institution

Hyderabad, India

Outcomes

Primary Outcomes

Number of Participants With Treatment-related Adverse Events

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.

Time frame: 26 Weeks

Secondary Outcomes

Number of Participants With Treatment-related Select Adverse Events

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.

Time frame: 26 Weeks

Number of Participants With Treatment-related Serious Adverse Events

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.

Time frame: 26 Weeks

Number of Participants With Adverse Events Leading to Discontinuation

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.

Time frame: 26 Weeks

Data from ClinicalTrials.gov

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