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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
Must not have
History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Has received cytotoxic chemotherapy for melanoma at any point prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had another cancer but was treated successfully and have been cancer-free for 2 years.
Select...
I have had chemotherapy for melanoma before joining this study.
Select...
I have a history of Hepatitis B or an active Hepatitis C infection.
Select...
I have or had lung inflammation that needed steroids.
Select...
I have an active tuberculosis infection.
Select...
My cancer has spread to my brain or its coverings.
Select...
I've had treatment after PD-1/PD-L1 therapy before joining this study.
Select...
I am currently on medication for an infection.
Select...
I have been diagnosed with HIV.
Select...
I have received an organ or tissue transplant from another person.
Select...
My melanoma is in the eye or on mucous membranes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~3150
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
4,012 Previous Clinical Trials
5,185,391 Total Patients Enrolled
124 Trials studying Melanoma
22,157 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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