Phase 2
N=1,009
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT02156804 ↗Enrolled (actual)
1,009
Serious AEs
58.8%
Results posted
Feb 2020
Primary outcome: Primary: the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events. — 16; 0; 30; 0 Number of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (BMS-936558) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events. |
16; 0; 30; 0; 6; 0 | — |
| SECONDARY The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events |
24; 0; 52; 1; 7; 1 | — |
| SECONDARY Median Time to Onset (Grades 3-4) of Select Adverse Events |
12; 23.50; 10.14; 14.86; 11.71; 34.36 | — |
| SECONDARY Median Time to Resolution (Grades 3-4) of Select Adverse Events |
2.43; 3.71; 9.43; 2.57; 1.93; 5.07 | — |
| SECONDARY Overall Survival |
21.2 | — |
Summary
The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Subjects with histologically confirmed malignant melanoma
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
- PS 0 to 1
- PS 2
- Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status
- Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression
- Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed
- Patients with CNS metastases are eligible:
- if CNS metastases are treated, patients are asymptomatic or neurologically returned to baseline
- if they have previously untreated CNS metastases and are asymptomatic
- if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy > 3 months
- Patients with a known history of Grades 3-4 immune-related adverse reactions during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1
Exclusion Criteria
- Subjects with untreated, active Central Nervous System (CNS) metastases are excluded
Data sourced from ClinicalTrials.gov (NCT02156804). 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.