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Completed

NCT Number: NCT03444766

Study of Nivolumab for Advanced Cancers in India

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

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Cancer Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Non-Small-Cell Lung Carcinoma Nonsmall Cell Lung Cancer Renal Cancer Renal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, Bangalore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

specified dose on specified days

Other names: Opdivo

Primary outcomes

  1. Number of Participants With Treatment-related Adverse Events

    Time frame: 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 outcomes

  1. Number of Participants With Treatment-related Select Adverse Events

    Time frame: 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.

  2. Number of Participants With Treatment-related Serious Adverse Events

    Time frame: 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.

  3. Number of Participants With Adverse Events Leading to Discontinuation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Safety Study of Nivolumab for Selected Advanced Malignancies in India

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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