Phase 3
Completed N=405
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Unresectable or Metastatic Melanoma
Source: ClinicalTrials.gov NCT01721746 ↗
Enrolled (actual)
405
Serious AEs
61.6%
Results posted
Mar 2017
Primary outcomePrimary: Objective Response Rate (ORR) — 27.2; 9.8 Percentage of participants
◆ Published Evidence
Highly cited
2,662citations · ~242 / year
Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial.
Summary
The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel
Linked Publications (2)
-
Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial.
-
Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
27.2; 9.8 | — |
| PRIMARY Overall Survival (OS) |
15.74; 14.39 | — |
| SECONDARY Progression Free Survival (PFS) |
3.12; 3.65 | — |
| SECONDARY Objective Response Rate (ORR) by Baseline PD-L1 Expression |
15.3; 13.8; 43.2; 12.2 | — |
| SECONDARY Overall Survival (OS) by PD-L1 Positive |
31.44; 16.72 | — |
| SECONDARY Overall Survival (OS) by PD-L1 Negative |
11.14; 11.76 | — |
| SECONDARY Mean Change From Baseline in Health-related Quality of Life (HRQoL) |
-7.97; -12.73; -3.66; -7.14; -14.94; -15.91 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Men & women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Histologically confirmed Stage III (unresectable)/Stage IV melanoma
- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
- Pre-treatment fresh core, excision or punch tumor biopsy
- Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
Exclusion Criteria
- Any treatment in a BMS-936558 (Nivolumab) trial
- Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
- Active, known or suspected autoimmune disease
- Unknown BRAF status
- Active brain metastasis or leptomeningeal metastasis
- Ocular melanoma
- Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
Data sourced from ClinicalTrials.gov (NCT01721746) 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.