Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— CheckMate 907  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090737
• Other study ID #: CA209-907
• Secondary ID: 2016-003731-37
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2017
• Est. completion date: March 14, 2022

Study information

• Verified date: December 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 14, 2022
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Biological:
• Nivolumab
Specified Dose on Specified Days

Locations

Country	Name	City	State
Canada	Local Institution - 0015	Kingston	Ontario
Canada	Local Institution - 0014	Oshawa	Ontario
Canada	Local Institution - 0001	Toronto	Ontario
Japan	Local Institution - 0018	Koto-ku	Tokyo
Japan	Local Institution - 0017	Nagoya	Aichi
Japan	Local Institution - 0023	Osaka-shi	Osaka
Japan	Local Institution - 0016	Tokyo
Romania	Local Institution - 0003	Craiova
Romania	Local Institution - 0006	Sector 2
South Africa	Local Institution - 0012	George	Western CAPE
South Africa	Local Institution - 0013	Parktown, Johannesburg	Gauteng
South Africa	Local Institution - 0011	Port Elizabeth	Eastern Cape
United States	St Vincent Frontier Cancer Center	Billings	Montana
United States	Alabama Oncology	Birmingham	Alabama
United States	Broome Oncology	Johnson City	New York
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	Guthrie Medical Group Sayre	Sayre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Canada,  Japan,  Romania,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE)	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	Progression Free Survival (PFS)	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)
Secondary	Objective Response Rate (ORR)	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).
Secondary	Overall Survival (OS)	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)
Secondary	Duration of Response (DOR)	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).

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls