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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721759
First received: November 2, 2012
Last updated: September 23, 2015
Last verified: September 2015
  Purpose
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

Condition Intervention Phase
Squamous Cell Non-small Cell Lung Cancer
Drug: Nivolumab
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 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC) [ Time Frame: Day 1 of treatment to approximately 19 months ] [ Designated as safety issue: No ]
    ORR is defined as the number of patients with best overall response of confirmed complete response or partial response divided by the number of patients who received treatment. Participants were evaluated for tumor response 8 weeks (+/- 5 days) from start of study and every 6 weeks (+/- 5 days) thereafter. The IRC-assessed ORR (using Response Evaluation Criteria in Solid Tumors, volume 1.1, 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.

  • Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC) [ Time Frame: Day 1 of treatment to approximately 16 months ] [ Designated as safety issue: No ]
    ORR is defined as the number of patients with best overall response of confirmed complete response or partial response divided by the number of patients who received treatment. Participants were evaluated for tumor response 8 weeks (+/- 5 days) from start of study and every 6 weeks (+/- 5 days) thereafter. The IRC-assessed ORR (using Response Evaluation Criteria in Solid Tumors, volume 1.1, 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.


Secondary Outcome Measures:
  • Objective Response Rate (ORR) as Assessed by Investigator [ Time Frame: Day 1 of treatment to approximately 16 months ] [ Designated as safety issue: No ]
    ORR is defined as the number of patients with best overall response of confirmed complete response or partial response divided by the total number of patients who received treatment. Participants were evaluated for tumor response 8 weeks (+/- 5 days) from start of study and every 6 weeks (+/- 5 days) thereafter. Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using Response Evaluation Criteria in Solid Tumors, volume 1.1, to confirm response.


Enrollment: 140
Study Start Date: November 2012
Estimated Study Completion Date: August 2016
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Nivolumab
Other Name: BMS-936558

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 33 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: September 14, 2015
Last Updated: September 23, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 11, 2016