Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

Squamous Cell Non-small Cell Lung Cancer Clinical Trial

Official title:

A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721759
• Other study ID #: CA209-063
• Secondary ID: 2012-003965-16
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2012
• Est. completion date: April 22, 2021

Study information

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

Clinical Trial Summary

The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 22, 2021
• Est. primary completion date: January 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Men and women =18 years of age
• Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation for locally advanced disease
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
• Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1

Exclusion Criteria:

• Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of =10 mg prednisone daily (or equivalent)
• Carcinomatous meningitis
• Active known or suspected autoimmune disease or interstitial lung disease
• Prior treatment on either arm of study CA209-017 or CA184-104
• Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
• A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nivolumab

Locations

Country	Name	City	State
France	Local Institution	Caen
France	Local Institution	Creteil
France	Local Institution	Pierre Benite
France	Local Institution	Rennes
France	Local Institution	Strasbourg
France	Local Institution	Toulouse
France	Local Institution	Villejuif
Germany	Local Institution	Berlin
Germany	Local Institution	Koeln
Germany	Local Institution	Muenchen
Italy	Local Institution	Livorno
Italy	Local Institution	Lucca
Italy	Local Institution	Terni
United States	Network Office of Research and Innovation	Allentown	Pennsylvania
United States	Winship Cancer Institute.	Atlanta	Georgia
United States	Tufts Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University Of North Carolina At Chapel Hill	Chapel Hill	North Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Oncology Consultants, Pa	Houston	Texas
United States	Local Institution	Metairie	Louisiana
United States	Henry-Joyce Cancer Center	Nashville	Tennessee
United States	Beth Israel Comprehensive Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University Of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Providence Oncology And Hematology	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University Of California Davis Medical Center	Sacramento	California
United States	Va San Diego Healthcare System	San Diego	California
United States	Providence Cancer Institute	Southfield	Michigan
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)	ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.; The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.	Day 1 of treatment up to approximately 14 months
Primary	Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC)	DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.	From the first treatment to the date of the first documented tumor progression or death. Approximately up to 14 months
Secondary	Objective Response Rate (ORR) as Assessed by Investigator	ORR is defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment.; The investigator-assessed ORR is summarized by a binomial response rate and its corresponding two-sided 95% exact CIs using Clopper-Pearson method.	Day 1 of treatment to approximately 101 months
Secondary	Duration of Response (DOR) as Assessed by Investigator	DOR is defined as the time from first confirmed response (CR or PR) per investigator assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.	From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 months

External Links

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