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Dapansutrile + Pembrolizumab for Melanoma
Phase 1 & 2
Recruiting
Led By April Salama
Research Sponsored by April Salama, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has histologically or cytologically confirmed melanoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is designed to find a safe dose of dapansutrile to combine with pembrolizumab, and to assess the preliminary efficacy of this combination in treating melanoma that is resistant to PD-1 inhibitors.
Who is the study for?
This trial is for adults with advanced melanoma that didn't respond to previous anti-PD-1/PD-L1 therapy. They must have measurable disease, adequate organ function, and no other recent cancer treatments or active infections. Participants need a performance status of 0-2 and can't be pregnant or breastfeeding. Those with certain health conditions like immunodeficiency, pneumonitis, or CNS metastases are excluded.Check my eligibility
What is being tested?
The study tests Dapansutrile in combination with Pembrolizumab on patients whose melanoma resisted PD-1 inhibitors. It has two parts: finding the best dose (with up to 1000 mg BID of Dapansutrile) and then expanding the trial at this dose to assess effectiveness against advanced melanoma.See study design
What are the potential side effects?
Potential side effects include typical reactions related to immune therapies such as inflammation in various organs, infusion-related reactions, fatigue, possible digestive issues, skin reactions and an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma diagnosis was confirmed through lab tests.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been treated with anti-PD-1/PD-L1 therapy for over 8 weeks and my cancer has progressed.
Select...
My melanoma cannot be surgically removed and is in an advanced stage.
Select...
I have been treated with an anti-PD-1/PD-L1 drug as my latest treatment.
Select...
My cancer progressed after treatment with an anti-PD-1/PD-L1 therapy.
Select...
My cancer has worsened within 6 months after my last anti-PD-1/L1 treatment.
Select...
I can provide a sample of my tumor, either from previous storage or a new biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of AEs (including SAEs and DLTs) as measured by patient interview and medical record review
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.
Secondary outcome measures
Overall survival as measured by the number of patients who die due to any cause
Progression free survival as measured by the number of patients that have not experienced radiographic disease progression
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose SelectionExperimental Treatment2 Interventions
Dapansutrile 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.
Group II: Dose ExpansionExperimental Treatment2 Interventions
Dapansutrile at the RP2D plus Pembrolizumab 200 mg IV every three weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Olatec Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,033 Total Patients Enrolled
April Salama, M.D.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,908 Previous Clinical Trials
5,066,661 Total Patients Enrolled
120 Trials studying Melanoma
22,173 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma diagnosis was confirmed through lab tests.I had another cancer but was treated successfully and have been cancer-free for 2 years.My cancer got worse within 6 months after my last anti-PD-1/L1 treatment.My side effects from cancer treatment are mild, except for hair loss or hormone issues.I am 18 years or older and have given my consent.I have had chemotherapy for melanoma before joining this study.I can take care of myself and am up and about more than half of my waking hours.I have been treated with anti-PD-1/PD-L1 therapy for over 8 weeks and my cancer has progressed.You have a disease that can be measured using a specific set of guidelines.My organs are functioning well.I have a history of Hepatitis B or an active Hepatitis C infection.I have or had lung inflammation that needed steroids.I have an active tuberculosis infection.I have been treated for an autoimmune disease in the last 2 years.My melanoma cannot be surgically removed and is in an advanced stage.I am not pregnant or breastfeeding and either cannot become pregnant or will use birth control during and after the study.My cancer has spread to my brain or its coverings.I am a man and will use birth control during and for 4 months after treatment, and won't donate sperm.I've had treatment after PD-1/PD-L1 therapy before joining this study.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last 14 days.I am currently on medication for an infection.I have been diagnosed with HIV.I have received an organ or tissue transplant from another person.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have been treated with an anti-PD-1/PD-L1 drug as my latest treatment.My cancer progressed after treatment with an anti-PD-1/PD-L1 therapy.My melanoma is in the eye or on mucous membranes.My cancer has worsened within 6 months after my last anti-PD-1/L1 treatment.I can provide a sample of my tumor, either from previous storage or a new biopsy.I had radiotherapy less than 2 weeks ago.You have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Selection
- Group 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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