Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01176461 | Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558 | PHASE1 | COMPLETED | 127 | — | — | Aug 4, 2010 | Dec 12, 2016 | Jan 18, 2023 | 1 | United States |
The primary analysis is the BORR as determined using irRC. The BORR will be summarized using descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| A1 - Phase I Dose Escalation | EXPERIMENTAL | Cohorts 1 through 5. Each treatment cycle is comprised of 6 doses of BMS-936558 and 6 peptide vaccines administered every 2 weeks for 12 weeks (cohort 6 has no peptides) (Cycle 1: Weeks 1, 3, 5, 7, 9, and 11; Cycle 2: Weeks 13, 15, 17, 19, 21, and 23) with tumor response assessments at the end of each cycle (during Weeks 12 and 24). |
| A2 - BMS-936558 Without Peptide Vaccine | ACTIVE_COMPARATOR | Cohort 6. Each treatment cycle is comprised of 6 doses of BMS-936558 administered every 2 weeks for 12 weeks (cohort 6 has no peptides) (Cycle 1: Weeks 1, 3, 5, 7, 9, and 11; Cycle 2: Weeks 13, 15, 17, 19, 21, and 23) with tumor response assessments at the end of each cycle (during Weeks 12 and 24). |
| Name | Type | Description |
|---|---|---|
| MART-1 | BIOLOGICAL | THIS PEPTIDE REMOVED FROM STUDY ON 1/1/2013. MART-1:26-35(27L) peptide vaccine |
| NY-ESO-1 | BIOLOGICAL | NY-ESO-1 peptide vaccine |
| gp100:209-217(210M) | BIOLOGICAL | THIS PEPTIDE REMOVED FROM STUDY ON 1/1/2013. gp100:209-217(210M) peptide vaccine |
| gp100:280-288(288V) | BIOLOGICAL | gp100:280-288(288V) peptide vaccine |
| Montanide ISA 51 VG | DRUG | Administer peptide vaccine emulsions prepared with Montanide® ISA 51 VG by deep subcutaneous injection. |
| BMS-936558 | BIOLOGICAL | BMS-936558 is a fully human monoclonal antibody (HuMAb) against programmed death-1 (PD-1). Level 1: 1 mg/kg cohort; Level 2: 3 mg/kg cohort; Level 3: 10 mg/kg cohort; Level 4: 3 mg/kg prior ipi gr 0/1/2 cohort; Level 5: 3 mg/kg prior ipi gr 3 cohort; Level 6: 3 mg/kg BMS-936558 (no peptide vaccine; human leukocyte antigen \[HLA\] unrestricted) |
Inclusion Criteria: * Histologic diagnosis of unresectable Stage III or IV melanoma. All melanomas regardless of primary site of disease will be allowed * Measurable unresectable melanoma at least 1 measurable lesion based on Immune-related Response Criteria (irRC) * Have failed at least 1 chemothe...