Study of Nivolumab for Advanced Cancers in India

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

Official Title
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Safety Study of Nivolumab for Selected Advanced Malignancies in India

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

Intervention / Treatment
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* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monotherapy<br>administering nivolumab only | Drug: Nivolumab<br>* specified dose on specified days<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 26 Weeks |