Phase 3
Completed N=945
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
Unresectable or Metastatic Melanoma
Source: ClinicalTrials.gov NCT01844505 ↗
Enrolled (actual)
945
Serious AEs
68.4%
Results posted
Sep 2017
Primary outcomePrimary: Progression Free Survival (PFS) — 6.87; 11.50; 2.89 months — p=<0.0001
◆ Published Evidence
Highly cited
3,692citations · ~527 / year
Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.
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.
Linked Publications (5)
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Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.
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Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma.
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Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma.
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Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma.
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Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
6.93; 11.50; 2.86 | — |
| PRIMARY Overall Survival (OS) |
36.93; 71.92; 19.94 | — |
| PRIMARY Rate of Overall Survival |
0.85; 0.86; 0.82; 0.74; 0.73; 0.67 | — |
| PRIMARY Rate of Progression-Free Survival |
0.52; 0.63; 0.28; 0.43; 0.50; 0.18 | — |
| SECONDARY Progression Free Survival (PFS) |
6.93; 11.50; 2.86 | — |
| SECONDARY Overall Survival (OS) |
36.93; 71.92; 19.94 | — |
| SECONDARY Objective Response Rate (ORR) Per Investigator Assessment |
44.9; 58.3; 19.0 | <0.0001 sig |
| SECONDARY Progression-Free Survival Based on PD-L1 Expression Level |
2.83; 11.17; 2.76; 16.20; 16.72; 3.48 | — |
| SECONDARY Overall Survival Based on PD-L1 Expression Level |
23.46; NA; 18.56; 85.09; 82.30; 21.49 | — |
| SECONDARY Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status |
-2.8; -4.3; -3.1; -2.6; -5.0; -4.3 | — |
| SECONDARY Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning |
-1.2; -4.6; -1.6; -0.1; -5.8; -0.2 | — |
| SECONDARY Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning |
0.1; -2.1; -0.2; -1.7; -3.6; -1.5 | — |
| SECONDARY Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning |
4.6; 2.5; 3.7; 4.0; 2.0; 3.1 | — |
| SECONDARY Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning |
-4.1; -6.8; -4.4; -3.6; -11.6; -4.9 | — |
| SECONDARY Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning |
-2.6; -4.9; -5.2; -2.4; -5.3; -5.1 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01844505) and the linked publication. 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.