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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090737
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : August 21, 2019
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

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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 : September 28, 2020
Estimated Study Completion Date : January 18, 2021

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 ]


Information from the National Library of Medicine

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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


Locations
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United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35205
United States, California
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States, 90017
United States, Montana
St Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
United States, New York
Broome Oncology
Johnson City, New York, United States, 13790
United States, Pennsylvania
Guthrie Medical Group, Pc
Sayre, Pennsylvania, United States, 18840
Canada, Ontario
Cancer Centre Of Southeastern Ontario At Kgh
Kingston, Ontario, Canada, K7L 2V7
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Japan
Local Institution
Nagoya, Aichi, Japan, 4648681
Local Institution
Chuo-ku, Osaka, Japan, 5418567
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Local Institution
Koto, Tokyo, Japan, 135-8550
Romania
Local Institution
Bucharest, Romania, 020122
Local Institution
Craiova, Romania, 200347
South Africa
Local Institution
Port Elizabeth, Eastern CAPE, South Africa, 6045
Local Institution
Parktown, Johannesburg, Gauteng, South Africa, 2193
Local Institution
George, Western CAPE, South Africa, 6530
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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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: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Immunological
Antineoplastic Agents