Study of BMS-936558 in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens - Full Text View

Purpose

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

Condition	Intervention	Phase
Squamous Cell Non-small Cell Lung Cancer	Drug: BMS-936558 (Anti-PD-1)	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single-Arm Phase 2 Study of BMS-936558 in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Primary endpoint of investigator-assessed Objective response rate (ORR) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
Defined as the number of subjects with a confirmed best overall response (BOR) of Complete response (CR) or Partial response (PR) divided by the number of treated subjects

Secondary Outcome Measures:

The secondary endpoint of ORR as assessed by Independent radiology review committee (IRC) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A: BMS-936558 (Anti-PD-1) BMS-936558 will be dosed intravenously (IV) over 60 minutes at 3 mg/kg every two weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	Drug: BMS-936558 (Anti-PD-1)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and Women ≥ 18 years of age
Subjects with histologically- or cytologically-documented squamous cell NSCLC 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 recurrent disease following radiation therapy or surgical resection
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Disease progression or recurrence after both first-line platinum doublet chemotherapy and at least one United States-Food and Drug Administration (US FDA) or European Medicines Agency (EMA)-approved subsequent line of systemic therapy
Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Exclusion Criteria:

Active Central nervous system (CNS) metastases. Subjects are eligible if metastases are adequately treated and subjects are 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, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
Subjects with carcinomatous meningitis
Active known or suspected autoimmune disease or subjects with interstitial lung disease
Prior treatment on either arm of study CA209017 or CA184104
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 co-stimulation or checkpoint pathways
Subjects with a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721759

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 32 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharma USA Inc

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01721759 History of Changes
Other Study ID Numbers:	CA209-063, 2012-003965-16
Study First Received:	November 2, 2012
Last Updated:	March 29, 2013
Health Authority:	United States: Food and Drug Administration Austria: Federal Office for Safety in Health Care France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Spain: Spanish Agency of Medicines United States: Institutional Review Board

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013