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SCCA Clinical Studies: Lung Cancer

Safety and Tolerability of Nivolumab (BMS-936558) for Non-small Cell Lung Cancer (UW11037)
A Multi-arm Phase I Safety Study of Nivolumab in Combination with Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab maintenance, Erlotinib, Ipilimumab or monotherapy in First line or in Switch Maintenance in Subjects with Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
Status Conditions Phase Study ID
Recruiting Non-small Cell Lung Cancer Phase I UW11037
NCT01454102
Summary

There is no formal research hypothesis to be statistically tested in this protocol. The study is expected to evaluate the safety and tolerability of BMS-936558 when combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine; Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in patients with non-small cell lung cancer.


Investigator
Laura Q.M. Chow, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Newly diagnosed and confirmed Stage IIIB/IV NSCLC
  • Men and women aged ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Subjects must be chemotherapy-naive
  • Either a formalin fixed tissue block or 10 to 15 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
Exclusions (conditions that would prevent participation in this study)
  • 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
  • History of transient ischemic accident, cerebrovascular accident, thrombotic or thromboembolic event (pulmonary embolus or deep venous thrombosis) within the last 6 months
  • Subjects with history of hemoptysis greater than 10 mL/day within the last 30 days
  • Subjects with interstitial pneumonia or pulmonary fibrosis by imaging diagnosis of the chest or clinical symptoms
  • Uncontrolled or significant cardiovascular disease
  • Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
  • Known positive history of Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome (AIDS)
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • History of allergy to study drug components
  • Pregnant or nursing
Last Updated
February 28, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.