Study of Nivolumab for Advanced Cancers in India

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Nivolumab

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Monotherapy

Arm Description

administering nivolumab only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03444766

First Posted

February 20, 2018

Last Updated

December 3, 2020

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03444766

Brief Title

Study of Nivolumab for Advanced Cancers in India

Official Title

Safety Study of Nivolumab for Selected Advanced Malignancies in India

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

March 6, 2018 (Actual)

Primary Completion Date

July 17, 2019 (Actual)

Study Completion Date

July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Monotherapy

Arm Type

Experimental

Arm Description

administering nivolumab only

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

specified dose on specified days

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-related Adverse Events

Description

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 Outcome Measure Information:

Title

Number of Participants With Treatment-related Select Adverse Events

Description

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

Title

Number of Participants With Treatment-related Serious Adverse Events

Description

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

Title

Number of Participants With Adverse Events Leading to Discontinuation

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560027

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560072

Country

India

Facility Name

Local Institution

City

Bengaluru

ZIP/Postal Code

560054

Country

India

Facility Name

Local Institution

City

Hyderabad

ZIP/Postal Code

500034

Country

India

Facility Name

Local Institution

City

Jaipur

ZIP/Postal Code

302004

Country

India

Facility Name

Local Institution

City

Kolkata

ZIP/Postal Code

700156

Country

India

Facility Name

Local Institution

City

Mumbai

ZIP/Postal Code

400012

Country

India

Facility Name

Local Institution

City

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Local Institution

City

Vellore

ZIP/Postal Code

632004

Country

India

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Non-Small Cell Lung Cancer (NSCLC), Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial