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NCT04971499 · ClinicalTrials.gov registry record · Phase 1
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
A Phase 1 study of Melanoma, sponsored by April Salama, M.D..
- Active
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT04971499 is a Phase 1 study of Melanoma that is active but no longer recruiting, run by April Salama, M.D.. The registered enrollment target is 26 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04971499, a Phase 1 study of Melanoma, is active but no longer recruiting, sponsored by April Salama, M.D..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Dapansutrile
Study Locations (1)
North Carolina
- Duke Cancer Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04971499
The ClinicalTrials.gov registry entry for NCT04971499 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The listed sponsor is April Salama, M.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04971499 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04971499 about?
NCT04971499 is a clinical study titled "A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma". 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 + pe...
What is the current status of trial NCT04971499?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2022-09-06. Estimated completion is 2027-04-30.
What conditions does trial NCT04971499 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04971499?
The interventions under investigation include: Pembrolizumab (DRUG), Dapansutrile (DRUG).
Who is sponsoring clinical trial NCT04971499?
This trial is sponsored by April Salama, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04971499 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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