Phase 3
N=418
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01721772 ↗Enrolled (actual)
418
Serious AEs
59.4%
Results posted
Feb 2016
Primary outcome: Primary: Overall Survival (OS) — NA; 10.84 Months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BMS-936558 (Nivolumab) (Biological); Placebo matching BMS-936558 (Nivolumab) (Biological); Dacarbazine (Drug); Placebo matching Dacarbazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
NA; 10.84 | <0.0001 sig |
| PRIMARY Overall Survival (OS) Rate |
84.1; 71.8; 72.9; 42.1 | — |
| SECONDARY Progression-free Survival (PFS) |
5.06; 2.17 | <0.0001 sig |
| SECONDARY Progression-free Survival (PFS) Rate |
48.2; 20.0; 43.3; 7.4; 40.5; 5.2 | — |
| SECONDARY Objective Response Rate (ORR) |
42.4; 14.4 | <0.0001 sig |
| SECONDARY Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level |
53.36; 12.39; 26.97; 10.84 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life (HRQoL) Scores |
1.39; 2.32; 1.49; 3.81; 3.07; 3.15 | — |
Summary
The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Men and women ≥18 years of age
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
- Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
- Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
- Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize
Exclusion Criteria
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Any active, known, or suspected autoimmune disease
Data sourced from ClinicalTrials.gov (NCT01721772). 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.