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Dapansutrile + Pembrolizumab for Melanoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Dose Selection
- Group 2: Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is there any precedent for research involving Pembrolizumab?
"At present, 963 trials involving pembrolizumab are active globally with 122 of these studies in the concluding phase 3. Of this number, Houston Texas is home to several such experiments and there are 35,746 sites running clinical tests for this drug worldwide."
To what extent is enrollment for this experiment open to participants?
"Affirmative, clinicaltrials.gov provides evidence that this research is actively recruiting participants at one site, who were initially sought on September 6th 2022 and last updated on the 8th of that same month. 26 people are required for the trial to reach completion."
Under what circumstances is Pembrolizumab commonly prescribed?
"Pembrolizumab can be employed to treat malignant neoplasms, as well as unresectable melanoma and microsatellite instability high. It is also capable of managing the progression of diseases following chemotherapy treatments."
Does this clinical trial have any openings for volunteers?
"According to the information posted on clinicaltrials.gov, this study is currently seeking participants. The trial was first advertised on September 6th 2022 and was last updated two days later."
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