Phase 2
Completed N=138
Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)
Advanced or Metastatic Melanoma
Source: ClinicalTrials.gov NCT01783938 ↗
Enrolled (actual)
138
Serious AEs
84.1%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) During the Induction Period (Period 1 and 2) — 64.7; 51.4 Percentage of participants
Summary
The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) During the Induction Period (Period 1 and 2) |
64.7; 51.4 | — |
| SECONDARY Investigator-Assessed Response Rate at Week 25 |
54.7; 30.4 | — |
| SECONDARY Investigator-Assessed Duration of Response (DOR) |
NA; 57.66 | — |
| SECONDARY Investigator-Assessed Rate of Progression |
36.8; 62.9; 36.8; 60.0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Histologically confirmed unresectable Stage III or IV melanoma
- Treatment-naive or experienced disease recurrence or progression during or after one prior systemic regimen for advanced disease
- Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Known BRAF V600 mutation status or consent to BRAF V600 mutation testing
- Sufficient tumor tissue accessible for baseline and post-treatment biopsies.
Exclusion Criteria
- Active central nervous system (CNS) metastases
- Carcinomatous meningitis
- Active, known or suspected autoimmune disease
- Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
- Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4) antibody
- Prior treatment with other immunotherapies
- Prior therapy with BRAF inhibitor within 6 weeks of enrollment
Data sourced from ClinicalTrials.gov (NCT01783938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.