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
|Closed||Unresectable or Metastatic Melanoma||Phase III||
The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend survival compared to Ipilimumab alone.
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 UpdatedApril 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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