Study of Nivolumab for Advanced Cancers in India

Kidney Cancer Clinical Trial

Official title:

Safety Study of Nivolumab for Selected Advanced Malignancies in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444766
• Other study ID #: CA209-887
• Status: Completed
• Phase: Phase 4
• Start date: March 6, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: December 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nivolumab
specified dose on specified days

Locations

Country	Name	City	State
India	Local Institution	Bangalore
India	Local Institution	Bangalore
India	Local Institution	Bengaluru
India	Local Institution	Hyderabad
India	Local Institution	Jaipur
India	Local Institution	Kolkata
India	Local Institution	Mumbai
India	Local Institution	New Delhi
India	Local Institution	Vellore

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form