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

NCT ID: NCT01721759

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-16
• Study Completion Date: 2021-04-22

Brief 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

Conditions

Squamous Cell Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab, 3 mg/kg

Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

Interventions

Nivolumab

Intervention Type: DRUG

Other Intervention Names

BMS-936558

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

University Of California Davis Medical Center

Sacramento, California, United States

Va San Diego Healthcare System

San Diego, California, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Winship Cancer Institute.

Atlanta, Georgia, United States

Local Institution

Metairie, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Providence Cancer Institute

Southfield, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, 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 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

Providence Oncology And Hematology

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Network Office of Research and Innovation

Allentown, Pennsylvania, United States

University Of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Henry-Joyce Cancer Center

Nashville, Tennessee, United States

Oncology Consultants, Pa

Houston, Texas, United States

Local Institution

Caen, , France

Local Institution

Créteil, , France

Local Institution

Pierre-Bénite, , France

Local Institution

Rennes, , France

Local Institution

Strasbourg, , France

Local Institution

Toulouse, , France

Local Institution

Villejuif, , France

Local Institution

Berlin, , Germany

Local Institution

Cologne, , Germany

Local Institution

München, , Germany

Local Institution

Livorno, , Italy

Local Institution

Lucca, , Italy

Local Institution

Terni, , Italy

Countries

United States; France; Germany; Italy

References

Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

Reference Type: DERIVED

PMID: 32198149 (View on PubMed)

Rizvi NA, Mazieres J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20.

Reference Type: DERIVED

PMID: 25704439 (View on PubMed)

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2012-003965-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-063

Identifier Type: -

Identifier Source: org_study_id