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Clinical Trials (PDQ®)

Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentActive18 and overPharmaceutical / IndustryCA209-012
NCT01454102

Trial Description

Summary

There is no formal research hypothesis to be statistically tested in this protocol.

  • The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine; Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects with NSCLC.
  • The study is evaluating the safety and tolerability of Nivolumab as maintenance therapy in combination with Bevacizumab/Avastin that will be given after at least 4 cycles of platinum doublet chemotherapy.
  • The study is evaluating the safety and tolerability of Nivolumab in combination with Erlotinib among epidermal growth factor receptor (EGFR) mutation positive non-squamous NSCLC subjects and as monotherapy in subjects with NSCLC.
  • The study is evaluating the safety and tolerability of Nivolumab in combination with Ipilimumab in subjects with squamous and non-squamous NSCLC.
  • The study is evaluating the safety and tolerability of Nivolumab as switch maintenance therapy in subjects with squamous and non-squamous NSCLC.
  • The study is evaluating the safety and tolerability of Nivolumab as monotherapy among subjects with untreated, asymptomatic brain metastases and no evidence of cerebral edema.

Eligibility Criteria

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

Inclusion Criteria:

  • Newly diagnosed and confirmed Stage IIIB/IV NSCLC
  • Previously treated NSCLC with asymptomatic brain metastases (eligible for Arm M) See additional details below
  • Men and women aged ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Subject must be chemotherapy naive (except Arm D, K, L and M). Prior use of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is acceptable. For Arms D, K, and L, subjects must be non-progressors within 42 days after completion of first-line treatment with ≥4 cycles of Platinum Doublet chemotherapy with or without Bevacizumab. See below for Arm M
  • Either a formalin fixed tissue block or a minimum of 10 slides of tumor sample (archived or fresh) must be available for biomarker evaluation (a local pathologist must review for adequacy of sampling)
  • Life expectancy of at least 3 months
  • Prior radiotherapy must have been completed at least 2 weeks prior to study entry

For Arm M:

  • No more than 4 brain metastases
  • Each brain metastases ≤3 cm in size
  • No evidence of cerebral edema
  • Subjects must be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroids for ≥10 days prior to initiation of study treatment
  • At least 1 measurable target brain lesion >0.5 cm and no larger than 3 cm in diameter and/or 2 measurable brain target lesions >0.3 cm
  • No prior radiation therapy, surgery, or other local therapy for target brain lesions
  • Must have received at least one prior systemic anticancer therapy for NSCLC

Exclusion Criteria:

  • Subjects with symptomatic brain metastases, spinal cord compression, or intractable back pain due to a compressive or destructive mass
  • Subjects who require emergent use of systemic steroids, emergent surgery and/or radiotherapy
  • Any active or history of a known autoimmune disease
  • Subjects with previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric, or colon cancers or cervical cancers/dysplasia, or breast carcinoma in situ) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period
  • History of Grade ≥2 neuropathy
  • Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers SquibbStudy Director

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
  Email: Clinical.Trials@bms.com

Trial Sites

U.S.A.
California
  Santa Monica
 Santa Monica UCLA Medical Center
 Jonathan Goldman, Site 005 Ph: 310-633-8400
Connecticut
  New Haven
 Yale Cancer Center
 Scott Gettinger, Site 014 Ph: 203-737-4156
Florida
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Scott Antonia, Site 013 Ph: 813-745-3905
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Julie Brahmer, Site 001 Ph: 443-287-4114
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Naiyer Rizvi, Site 010 Ph: 646-888-4204
North Carolina
  Durham
 Duke Cancer Institute
 Neal Ready, Site 004 Ph: 919-681-4768
Pennsylvania
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Hossein Borghaei, Site 016 Ph: 215-214-1472
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David E Gerber, Site 006 Ph: 214-648-6551
Washington
  Seattle
 Seattle Cancer Care Alliance
 Laura Chow, Site 007 Ph: 206-288-7445
Canada
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Rosalyn Juergens, Site 008 Ph: 905-387-9711 Ext.64423
  Toronto
 Princess Margaret Hospital
 Frances A Shepherd, Site 003 Ph: 416-946-4501 Ext.5132
Quebec
  Ottawa
 The Ottawa Hospital Cancer Centre
 Scott Laurie, Site 002 Ph: 613-737-7700 Ext.70550

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01454102
ClinicalTrials.gov processed this data on September 29, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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