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Study of Nivolumab for Advanced Cancers in India

Bristol-Myers Squibb (BMS) logo

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)

100 participants in 1 patient group

Monotherapy
Experimental group
Description:
administering nivolumab only
Treatment:
Drug: Nivolumab

Trial documents
2

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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