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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07040436 | Assessment of Safety and Efficacy of OPM-101 Combined With Anti-PD-1 in Patients With Advanced Melanoma Showing Resistance to Anti-PD-1 | PHASE1 | NOT YET_RECRUITING | 41 | — | — | Sep 1, 2025 | Dec 1, 2027 | Jun 27, 2025 | - | — |
In the phase 1b: the recommended dose for phase 2a will be based on the independent assessement of safety of OPM-101 by the DSMB
In phase 2a, Disease Control Rate defined as CR, PR or SD as per RECIST v.1.1 criteria
| Arm | Type | Description |
|---|---|---|
| OPM-101 (in combination with pembrolizumab) | EXPERIMENTAL | OPM-101 will be administered as hard gelatin capsules twice a day for 24 weeks. In the Phase 1b, 2 doses of OPM-101 will be considered: 75 mg bid and 150 mg bid. At the end of this Phase 1b, a recommended dose for Phase 2a will be determined. During the Phase 2a, the recommended dose of OPM-101 will be administered bid over 24 weeks. OPM-101 will be administered in combination with authorized regimen of Pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| OPM-101 | DRUG | OPM-101 will be administered in combination with an authorized regimen of Pembrolizumab. Pembrolizumab will be administered by IV infusion either at a dose of 200 mg every 3 weeks or at a dose of 400 mg every 6 weeks, as per Principal Investigator's decision. |
Inclusion criteria 1. Written informed consent provided prior to any study-related procedure. 2. Histologically confirmed, unresectable or metastatic stage III or IV melanoma. 3. At least one measurable lesion per RECIST v.1.1 criteria. 4. Patients with a documented and confirmed Progressive Diseas...