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PRTX007 · 1 trial · 1 indication
Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the resected tumor specimen following completion of neoadjuvant therapy, as assessed by central pathology review.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant PRTX007 + Pembrolizumab (Response-Adapted Adjuvant Therapy) | EXPERIMENTAL | Participants with resectable Stage III melanoma will receive neoadjuvant treatment with PRTX007 in combination with pembrolizumab prior to definitive surgical resection. Following surgery, participants will receive response-adapted adjuvant therapy based on pathologic response. Participants achieving a major pathologic response (MPR) may receive observation or pembrolizumab alone, while participants without MPR will receive adjuvant PRTX007 in combination with pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| PRTX007 | DRUG | PRTX007 is an orally administered prodrug of PRX034, a Toll-like receptor 7 (TLR7) agonist designed to activate innate and adaptive immune responses. NEOADJUVANT REGIMEN * 600 mg orally once daily (safety run-in participants) or * 750 mg orally once daily (subsequent participants) * Administered 3 days on, 4 days off (7-day cycle) * Total of 9 cycles (9 weeks) ADJUVANT REGIMEN (IF NO MPR) * 750 mg orally once daily * Administered 3 days on, 4 days off * Total of 12 cycles (12 weeks) |
| Pembrolizumab | DRUG | Pembrolizumab is a programmed cell death protein-1 (PD-1) blocking antibody administered by intravenous infusion NEOADJUVANT REGIMEN * 200 mg IV every 3 weeks (Q3W) * Total of 3 cycles (9 weeks) ADJUVANT REGIMEN * 400 mg IV every 6 weeks (Q6W) for 7 cycles OR * 200 mg IV every 3 weeks (Q3W) for 14 cycles * Total duration: approximately 42 weeks |
Inclusion Criteria: * Adults aged 18 years or older * Histologically confirmed, resectable Stage III cutaneous melanoma. * Candidate for curative-intent surgical resection * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Adequate organ function * Able to provide written infor...