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Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 907)

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ClinicalTrials.gov Identifier: NCT03090737
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A study to evaluate the safety of Nivolumab in patients with advanced or metastatic non-small cell lung cancer

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Biological: Nivolumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Phase II Safety Study of Nivolumab in Participants With Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed During or After Receiving at Least One Prior Systemic Regimen (CheckMate 907: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 907)
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : August 11, 2020
Estimated Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab
Specified Dose on Specified Days
Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo




Primary Outcome Measures :
  1. Incidence of high grade (Grades 3-4 and Grade 5) treatment-related adverse events [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 2 years ]
  2. Objective Response Rate (ORR) as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 2 years ]
  3. Overall Survival (OS) [ Time Frame: Up to 2 years ]
  4. Duration of Response (DOR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 2 years ]


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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:

  • Non small cell lung cancer (Squamous or non-squamous)
  • At least one prior anti-cancer therapy that did not work
  • ECOG Performance Scale 0-1

Exclusion Criteria:

  • Cancer that has spread to the brain or leptomeninges unless there is no evidence of progression by MRI for 8 weeks after treatment is complete and within 28 days before first dose of study drug
  • Active, known or suspected autoimmune disease or infection
  • Prior immuno-oncology therapy
  • Corticosteroids within 2 weeks of study drug administration

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): NCT03090737


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
United States, Alabama
Alabama Oncology Recruiting
Birmingham, Alabama, United States, 35205
Contact: Ira Gore, Site 0021    205-803-4389      
United States, California
Los Angeles Hematology Oncology Medical Group Recruiting
Los Angeles, California, United States, 90017
Contact: Lasika Seneviratne, Site 0026    213-977-1214      
Local Institution Not yet recruiting
West Covina, California, United States, 91790
Contact: Site 0025         
United States, Florida
Cancer Specialists, Llc Withdrawn
Jacksonville, Florida, United States, 32256
United States, Montana
St Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59102
Contact: Patrick Cobb, Site 0024    406-238-6290      
United States, New York
Broome Oncology Recruiting
Johnson City, New York, United States, 13790
Contact: Ronald Harris, Site 0019    607-763-8065      
United States, Pennsylvania
Guthrie Medical Group, Pc Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Philip Lowry, Site 0022    570-887-2141      
Canada, Ontario
Cancer Centre Of Southeastern Ontario At Kgh Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Anna Tomiak, Site 0015         
Lakeridge Health Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Jeffrey Rothenstein, Site 0014         
University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Natasha Leighl, Site 0001         
Hungary
Local Institution Withdrawn
Debrecen, Hungary, 4032
Local Institution Withdrawn
Farkasgyepu, Hungary, H-8582
Local Institution Withdrawn
Torokbalint, Hungary, 2045
Japan
Local Institution Recruiting
Nagoya, Aichi, Japan, 4648681
Contact: Site 0017         
Local Institution Recruiting
Chuo-ku, Osaka, Japan, 5418567
Contact: Site 0023         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0016         
Local Institution Recruiting
Koto, Tokyo, Japan, 135-8550
Contact: Site 0018         
Romania
Local Institution Recruiting
Bucharest, Romania, 020122
Contact: Site 0006         
Local Institution Recruiting
Craiova, Romania, 200347
Contact: Site 0003         
South Africa
Local Institution Recruiting
Port Elizabeth, Eastern CAPE, South Africa, 6045
Contact: Site 0011         
Local Institution Recruiting
Parktown, Johannesburg, Gauteng, South Africa, 2193
Contact: Site 0013         
Local Institution Recruiting
George, Western CAPE, South Africa, 6530
Contact: Site 0012         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03090737     History of Changes
Other Study ID Numbers: CA209-907
2016-003731-37 ( EudraCT Number )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs