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

December 1, 2022 updated by: Bristol-Myers Squibb

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)

A study to evaluate the safety of Nivolumab in participants with advanced or metastatic non-small cell lung cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Local Institution - 0015
      • Oshawa, Ontario, Canada, L1G 2B9
        • Local Institution - 0014
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0001
  • Japan
      • Tokyo, Japan, 1040045
        • Local Institution - 0016
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution - 0017
    • Osaka
      • Osaka-shi, Osaka, Japan, 5418567
        • Local Institution - 0023
    • Tokyo
      • Koto-ku, Tokyo, Japan, 1358550
        • Local Institution - 0018
  • Romania
      • Craiova, Romania, 200347
        • Local Institution - 0003
      • Sector 2, Romania, 022328
        • Local Institution - 0006
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Local Institution - 0011
    • Gauteng
      • Parktown, Johannesburg, Gauteng, South Africa, 2193
        • Local Institution - 0013
    • Western CAPE
      • George, Western CAPE, South Africa, 6530
        • Local Institution - 0012
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Oncology
    • California
      • Los Angeles, California, United States, 90017
        • Los Angeles Hematology Oncology Medical Group
    • Montana
      • Billings, Montana, United States, 59102
        • St Vincent Frontier Cancer Center
    • New York
      • Johnson City, New York, United States, 13790
        • Broome Oncology
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group Sayre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nivolumab
Specified Dose on Specified Days
Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE)
Time Frame: From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)
The number of participants who experienced at least 1 select AE of Grade 3-5, judged to be related to study drug per investigator with onset on or after first dose of study treatment and within 30 days of last dose of study treatment, divided by number of treated participants. AE grade is defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria. The select AEs consist of pulmonary events, gastrointestinal events, hepatic events, renal events, skin events, endocrine events categories, thyroid disorders, diabetes, pituitary, adrenal disorder subcategories. Grade 3 is defined as severe or medically significant but not immediately life-threatening. Grade 4 is defined as life-threatening consequences and urgent intervention indicated. Grade 5 is defined as death related to AE.
From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From first dose to the date of the first documented tumor progression (up to approximately 5 months)
Progression free survival (PFS) 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. Participants will be censored at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
From first dose to the date of the first documented tumor progression (up to approximately 5 months)
Objective Response Rate (ORR)
Time Frame: From the date of first dose to the date of the initial objectively documented tumor progression or the date of subsequent therapy, whichever occurs first (up to approximately 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) as assessed by investigator per RECIST 1.1. 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. Radiographic tumor assessments will be conducted at Week 8 (+/- 7 days) and every 8 weeks (+/- 7 days) until up to 2 years or until disease progression (or until discontinuation of study therapy in patients receiving nivolumab beyond progression), lost to follow-up, or withdrawal of study consent.
From the date of first dose to the date of the initial objectively documented tumor progression or the date of subsequent therapy, whichever occurs first (up to approximately 25 months).
Overall Survival (OS)
Time Frame: From first dosing date and the date of death due to any cause (up to approximately 4 years and 9 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.
From first dosing date and the date of death due to any cause (up to approximately 4 years and 9 months)
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 approximately 48 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) as determined by complete response (CR) or partial response (PR), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including palliative local therapy) without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of the subsequent anti-cancer therapy (including palliative local therapy). 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.
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 approximately 48 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 2, 2017

Primary Completion (ACTUAL)

February 16, 2021

Study Completion (ACTUAL)

March 14, 2022

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-907
  • 2016-003731-37 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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