Study of Nivolumab for Advanced Cancers in India

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Renal Cancer; Kidney Neoplasms; Kidney Cancer; Non-Small Cell Lung Cancer (NSCLC); Renal Neoplasms

Treatments: Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03444766

CA209-887

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Monotherapy

Experimental group

Description:

administering nivolumab only

Treatment:

Drug: Nivolumab