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N/A

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
Patients who progress while receiving or within 6 months of receiving the last dose of anti-PD-1/L1 mAb in the neoadjuvant or adjuvant setting will be included
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 below
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My melanoma diagnosis was confirmed through lab tests.
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My cancer got worse within 6 months after my last anti-PD-1/L1 treatment.
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My side effects from cancer treatment are mild, except for hair loss or hormone issues.
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I am 18 years or older and have given my consent.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been treated with anti-PD-1/PD-L1 therapy for over 8 weeks and my cancer has progressed.
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My organs are functioning well.
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My melanoma cannot be surgically removed and is in an advanced stage.
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I am not pregnant or breastfeeding and either cannot become pregnant or will use birth control during and after the study.
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I am a man and will use birth control during and for 4 months after treatment, and won't donate sperm.
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I have been treated with an anti-PD-1/PD-L1 drug as my latest treatment.
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My cancer progressed after treatment with an anti-PD-1/PD-L1 therapy.
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My cancer has worsened within 6 months after my last anti-PD-1/L1 treatment.
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I can provide a sample of my tumor, either from previous storage or a new biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
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?

April Salama, M.D.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,869 Previous Clinical Trials
5,051,883 Total Patients Enrolled
120 Trials studying Melanoma
21,656 Patients Enrolled for Melanoma
Olatec Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,033 Total Patients Enrolled

Media Library

Dapansutrile (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04971499 — Phase 1 & 2
Melanoma Research Study Groups: Dose Selection, Dose Expansion
Melanoma Clinical Trial 2023: Dapansutrile Highlights & Side Effects. Trial Name: NCT04971499 — Phase 1 & 2
Dapansutrile (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04971499 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Apr 2024