Clinical Trials Logo
  1. Home
  2. Kidney Cancer
  3. NCT03444766
  4. Details
NCT03444766 Clinical Trial

Study of Nivolumab for Advanced Cancers in India

Kidney Cancer Clinical Trial

Official title:
Safety Study of Nivolumab for Selected Advanced Malignancies in India

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03444766
Other study ID # CA209-887
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 6, 2018
Est. completion date July 17, 2019

Study information
Verified date December 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 17, 2019
Est. primary completion date July 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nivolumab
specified dose on specified days

Locations
Country Name City State
India Local Institution Bangalore
India Local Institution Bangalore
India Local Institution Bengaluru
India Local Institution Hyderabad
India Local Institution Jaipur
India Local Institution Kolkata
India Local Institution Mumbai
India Local Institution New Delhi
India Local Institution Vellore

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 26 Weeks
Secondary 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.		 26 Weeks
Secondary 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.		 26 Weeks
Secondary 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.		 26 Weeks
See also
  Status Clinical Trial Phase
Completed NCT00541008 - Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer Phase 2
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01048892 - Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features Phase 1
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Withdrawn NCT00769990 - Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases Phase 1/Phase 2
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Recruiting NCT00301990 - Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer Phase 2
Completed NCT00098943 - NGR-TNF in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00467077 - Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer Phase 2
Terminated NCT00899860 - Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer N/A
Terminated NCT00089102 - Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer Phase 2
Completed NCT00021021 - RPI.4610 in Treating Patients With Metastatic Kidney Cancer Phase 2
Completed NCT00006968 - Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer Phase 1/Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1

External Links