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

NCT01721759 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CA209-0632012-003965-16
• Study Type: interventional
• Target: 117
• Locations: 4 countries
• Sites: 33

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Objective Response Rate (ORR) as Assessed by Investigator

  Day 1 of treatment to approximately 101 months

• Duration of Response (DOR) as Assessed by Investigator

  From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 months

Study Arms (1)

Nivolumab, 3 mg/kg

EXPERIMENTAL

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.

Drug: Nivolumab

Interventions

Nivolumab DRUG

Also known as: BMS-936558

Nivolumab, 3 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (33)

University Of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Va San Diego Healthcare System

San Diego, California, 92161, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute.

Atlanta, Georgia, 30322, United States

Location

Local Institution

Metairie, Louisiana, 70006, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Providence Cancer Institute

Southfield, Michigan, 48075, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Beth Israel Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27599-7305, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Providence Oncology And Hematology

Portland, Oregon, 97213, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Network Office of Research and Innovation

Allentown, Pennsylvania, 18103, United States

Location

University Of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Henry-Joyce Cancer Center

Nashville, Tennessee, 37232, United States

Location

Oncology Consultants, Pa

Houston, Texas, 77024, United States

Location

Local Institution

Caen, 14000, France

Location

Local Institution

Créteil, 94010, France

Location

Local Institution

Pierre-Bénite, 69495, France

Location

Local Institution

Rennes, 35033, France

Location

Local Institution

Strasbourg, 67090, France

Location

Local Institution

Toulouse, 31059, France

Location

Local Institution

Villejuif, 94800, France

Location

Local Institution

Berlin, 13125, Germany

Location

Local Institution

Cologne, 50937, Germany

Location

Local Institution

München, 80336, Germany

Location

Local Institution

Livorno, 57100, Italy

Location

Local Institution

Lucca, 55100, Italy

Location

Local Institution

Terni, 05100, Italy

Location

Related Publications (2)

• 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.

  PMID: 32198149 DERIVED

• 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.

  PMID: 25704439 DERIVED

Related Links

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

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 16, 2012
• Primary Completion: January 22, 2014
• Study Completion: April 22, 2021
• Last Updated: June 28, 2022
• Results First Posted: October 22, 2015

Record last verified: 2022-06

Locations

FR (7); IT (3); US (20); DE (3)