Status:
COMPLETED
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Unresectable or Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
945 Patients enrolled
Trial Details
Trial ID
NCT01844505
Start Date
June 11 2013
End Date
April 19 2024
Last Update
May 21 2025
Active Locations (150)
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1
Local Institution - 0085
Gilbert, Arizona, United States, 85234
2
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
Local Institution - 0046
La Jolla, California, United States, 92093-0698
4
Local Institution - 0053
Los Angeles, California, United States, 90025