A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Status:
Not yet recruiting
Trial end date:
2024-04-30
Target enrollment:
Participant gender:
Summary
This phase 1/2 trial will be conducted in two parts. Part 1 (Dose Selection) is designed to
find the dose of dapansutrile with acceptable tolerability in combination with pembrolizumab.
Part 1 will consist of up to 2 dose selection cohorts to evaluate the safety and tolerability
of dapansutrile + pembrolizumab in patients with PD-1 resistant melanoma to find the
recommended part 2 dose (RP2D). Part 1 will include a lead-in phase of dapansutrile
monotherapy at 500 mg PO BID. At day 15, combination therapy with pembrolizumab will be
initiated. Dose escalation is planned to a maximum of 1000 mg BID of dapansutrile +
pembrolizumab.
Part 2 (Dose Expansion) is designed to assess preliminary efficacy of dapansutrile +
pembrolizumab in PD-1 resistant melanoma. Once all patients in Part 1 have completed 4 weeks
of dapansutrile therapy, the expansion phase will start enrolling. Part 2 will also include a
14-day lead-in period of dapansutrile monotherapy at the RP2D.