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 : Completed
First Posted : March 27, 2017
Results First Posted : March 14, 2022
Last Update Posted : July 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Biological: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Specified Dose on Specified Days
Specified Dose on Specified Days
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|