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Dapansutrile

Phase 1

Melanoma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Feb 20, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Dapansutrile · 1 trial · 1 indication

Phase 1 1
NCT04971499A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced MelanomaMelanoma
ACTIVE NOT_RECRUITING26 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of AEs (including SAEs and DLTs) as measured by patient interview and medical record review
90 days after last dose
Objective response rate as measured by the percentage of patients who achieve a partial or complete response per RECIST v1.1 and iRECIST while receiving study therapy.
Up to 2 years

Secondary Endpoints

Progression free survival as measured by the number of patients that have not experienced radiographic disease progression
after 6 months
Overall survival as measured by the number of patients who die due to any cause
after 6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose SelectionEXPERIMENTALDapansutrile starting at 500 mg PO BID plus Pembrolizumab 200 mg IV every three weeks. Dose escalation is planned to a maximum of 1000 mg BID of dapansutrile + pembrolizumab.
Dose ExpansionEXPERIMENTALDapansutrile at the RP2D plus Pembrolizumab 200 mg IV every three weeks

Interventions

NameTypeDescription
DapansutrileDRUG500 mg tablet
PembrolizumabDRUGSingle-use vial containing 100 mg/4 mL of pembrolizumab
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Has histologically or cytologically confirmed melanoma. 2. Has unresectable Stage III or Stage IV melanoma, per AJCC 8th Edition Staging Criteria, not amenable to local therapy. 3. Male or female participants who are at least 18 years of age on the day of signing informed con...

Countries:United States
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Frequently asked questions about Dapansutrile

What is Dapansutrile used for in melanoma?

Dapansutrile is an investigational small molecule being studied for the treatment of PD-1 refractory advanced melanoma. It is currently in Phase 1 clinical development as a combination therapy with pembrolizumab for patients whose melanoma has not responded to PD-1 inhibitor therapy.

Who makes Dapansutrile?

Dapansutrile is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced melanoma.

What phase is Dapansutrile in?

Dapansutrile is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in patients with PD-1 refractory advanced melanoma.

What clinical trials is Dapansutrile in?

Dapansutrile is being evaluated in a Phase 1 clinical trial with the identifier NCT04971499. This study is investigating dapansutrile in combination with pembrolizumab in patients with PD-1 refractory advanced melanoma. The trial is active but not recruiting participants and is being conducted in the United States.

Is Dapansutrile the same as any other drug?

Dapansutrile is the primary name used for this investigational drug in clinical trials. No alternative names have been reported for this compound in the available clinical trial information.