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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 : Completed
First Posted : March 27, 2017
Results First Posted : March 14, 2022
Last Update Posted : July 20, 2022
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 participants 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)
Actual Enrollment : 129 participants
Allocation: N/A
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 : June 2, 2017
Actual Primary Completion Date : February 16, 2021
Actual Study Completion Date : March 14, 2022

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. Drug-Related Select Adverse Events (AE) by Worst CTC Grade (Grade 3-4, Grade 5) [ Time Frame: From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 45 months) ]
    The drug-related Grade 3 - 5 select AE rate is defined as number of participants who experienced at least 1 select AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. AE grade will be defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From the date of randomization to the date of the first documented tumor progression (up to 24 months) ]
    Progression free survival (PFS) primary definition is defined as the time between the date of randomization and the date of the first documented tumor progression accounting for subsequent therapy, based on BICR (blinded independent central review) assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

  2. Objective Response Rate (ORR) [ Time Frame: From the date of first dose to the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first (up to 25 months). ]
    Objective Response Rate (ORR) defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions.

  3. Overall Survival (OS) [ Time Frame: From first dosing date and the date of death due to any cause (up to 24 months) ]
    Overall Survival (OS) is defined as the time between the first dosing date and the date of death due to any cause. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.

  4. Duration of Response (DOR) [ Time Frame: From the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first (up to 47 months). ]
    Duration of Response (DOR) is defined as the time between the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first.



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

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
Show Show 17 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] July 10, 2020
Statistical Analysis Plan  [PDF] April 8, 2019

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03090737    
Other Study ID Numbers: CA209-907
2016-003731-37 ( EudraCT Number )
First Posted: March 27, 2017    Key Record Dates
Results First Posted: March 14, 2022
Last Update Posted: July 20, 2022
Last Verified: July 2022

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action