Study of Nivolumab for Advanced Cancers in India

Phase 4

Completed

• 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: Drug: Nivolumab

• Registration Number: NCT03444766
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-23
• Study Start: 2018-03-06
• Primary Completion: 2019-07-17
• Study Completion: 2019-07-17
• Results First Submitted: 2020-10-16
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-03
• Last Update Submitted: 2020-12-03
• Results First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monotherapy	Nivolumab	administering nivolumab only

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events	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 Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Select Adverse Events	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	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	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.

Trial Locations

Locations (1)

Local Institution; 🇮🇳 Vellore, India