Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Melanoma

Nivolumab Monotherapy vs. Nivolumab + Ipilimumab vs. Ipilimumab Monotherapy for Melanoma (20130618)
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma
Status Conditions Phase Study ID
Closed Unresectable or Metastatic Melanoma Phase III 20130618
NCT01844505
Summary

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend survival compared to Ipilimumab alone.


Investigator
Kim Margolin, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment naïve patients
  • Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
  • Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusions (conditions that would prevent participation in this study)
  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Subjects with active, known or suspected autoimmune disease
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
  • Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
Last Updated
April 10, 2014
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.