Clinical trial NCT03090737: Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-03-27
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE)
timeFrame: From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From first dose to the date of the first documented tumor progression (up to approximately 5 months)
measure: Objective Response Rate (ORR)
timeFrame: 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).
measure: Overall Survival (OS)
timeFrame: From first dosing date and the date of death due to any cause (up to approximately 4 years and 9 months)
measure: Duration of Response (DOR)
timeFrame: 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).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Billings
country: United States
facility: St Vincent Frontier Cancer Center
state: Montana
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: Sayre
country: United States
facility: Guthrie Medical Group Sayre
state: Pennsylvania
city: Kingston
country: Canada
facility: Local Institution - 0015
state: Ontario
city: Oshawa
country: Canada
facility: Local Institution - 0014
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0001
state: Ontario
city: Nagoya
country: Japan
facility: Local Institution - 0017
state: Aichi
city: Osaka-shi
country: Japan
facility: Local Institution - 0023
state: Osaka
city: Koto-ku
country: Japan
facility: Local Institution - 0018
state: Tokyo
city: Tokyo
country: Japan
facility: Local Institution - 0016
city: Craiova
country: Romania
facility: Local Institution - 0003
city: Sector 2
country: Romania
facility: Local Institution - 0006
city: Port Elizabeth
country: South Africa
facility: Local Institution - 0011
state: Eastern Cape
city: Parktown, Johannesburg
country: South Africa
facility: Local Institution - 0013
state: Gauteng
city: George
country: South Africa
facility: Local Institution - 0012
state: Western CAPE
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: