Phase 2
Completed N=142
Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma
Unresectable Melanoma · Melanoma
Source: ClinicalTrials.gov NCT01927419 ↗
Enrolled (actual)
142
Serious AEs
68.6%
Results posted
Feb 2016
Primary outcomePrimary: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants — 60.3; 10.8 Percentage of participants
Summary
The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants |
60.3; 10.8 | — |
| SECONDARY Progression-Free Survival (PFS) - BRAF Wild-type (WT) Participants |
58.41; 4.30 | — |
| SECONDARY Objective Response Rate (ORR) - BRAF Mutant Participants |
54.5; 10.0 | — |
| SECONDARY Progression-Free Survival (PFS) - BRAF Mutant Participants |
8.61; 2.73 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score |
2.12; 1.03; -1.52; 5.13; 8.33; 10.26 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Histologically confirmed unresectable Stage III or Stage IV melanoma
- No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized
- Tumor tissue obtained in the metastatic setting or from an unresectable site must be provided for biomarker analyses and sent to the central laboratory. Biopsy should be excisional, incisional punch, or core needle. Fine needle aspirates or other cytology samples are insufficient
- Known BRAF V600 mutation status as determined by an FDA-approved test. Patients with either V600 wild-type or V600 mutation-positive melanoma are eligible.
Key Exclusion Criteria
- Active brain metastases or leptomeningeal metastases. Patients with treated brain metastases are eligible if there is no evidence of progression on magnetic resonance imaging scan for at least 8 weeks after completion of treatment and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
- Ocular melanoma
- Patients with active, known, or suspected autoimmune disease. Those with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Data sourced from ClinicalTrials.gov (NCT01927419). 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.