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Study of Nivolumab for Advanced Cancers in India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444766
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Non-Small-Cell Lung Carcinoma Nonsmall Cell Lung Cancer Kidney Cancer Kidney Neoplasms Renal Cancer Renal Neoplasms Drug: Nivolumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Nivolumab for Selected Advanced Malignancies in India
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : July 17, 2019
Estimated Study Completion Date : April 29, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Monotherapy
administering nivolumab only
Drug: Nivolumab
specified dose on specified days
Other Name: Opdivo




Primary Outcome Measures :
  1. Number of Adverse Events (AE) [ Time Frame: 26 Weeks ]

Secondary Outcome Measures :
  1. Number of treatment-related Serious Adverse Events (SAE) [ Time Frame: 26 Weeks ]
  2. Number of AE that lead to discontinuation from treatment with nivolumab [ Time Frame: 26 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444766


Locations
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India
Local Institution
Bangalore, India, 560027
Local Institution
Bangalore, India, 560072
Local Institution
Bengaluru, India, 560054
Local Institution
Hyderabad, India, 500034
Local Institution
Jaipur, India, 302004
Local Institution
Kolkata, India, 700156
Local Institution
Mumbai, India, 400012
Local Institution
New Delhi, India, 110029
Local Institution
Vellore, India, 632004
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03444766    
Other Study ID Numbers: CA209-887
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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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
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Kidney Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents