Can a DNA repair gene flaw make melanoma vulnerable to chemotherapy?
NCT ID NCT07807878
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase II trial tests whether the chemotherapy drug temozolomide can shrink tumors in people with advanced or metastatic melanoma that has a mutation in the BAP1 gene. BAP1 normally helps repair damaged DNA, and when it is faulty, cancer cells may become more sensitive to certain drugs. The study enrolls adults whose melanoma has progressed after at least one line of immunotherapy. Participants receive temozolomide in cycles, and researchers measure how many respond to treatment after about three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- temozolomide
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced melanoma that carries a BAP1 mutation, especially after immunotherapy has stopped working.
- What could go wrong
- This is a small, early-phase trial with only 28 participants. The benefit is uncertain, and temozolomide can cause side effects like low blood cell counts and fatigue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patient (≥18 years old) * Patients who have received information about the study and have signed an informed consent form. * Histopathological confirmation of a diagnosis of stage III (unresectable) or stage IV (metastatic) cutaneous melanoma according to the 8th edition of the AJCC staging system. * Patient has experienced treatment failure after undergoing at least one line of Immunotherapy with at least one immune checkpoint inhibitor (anti-PD1, anti-PD1+anti-CTLA4, or anti-PD1+anti-LAG3) and one line of targeted therapy combining BRAF and MEK inhibitors, if indicated. * The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or lower. * The patient must have at least one measurable lesion defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). * The patient must have a pathogenic BAP1 alteration identified by a molecular biology technique in tumor tissue or in circulating cell-free DNA. * The inclusion of patients is subject to the following criteria: * Absolute neutrophil count ≥ 1.5 x 109/L (≥ 1500 per mm3) * Platelet count ≥ 100 x 109/L * Hemoglobin ≥ 9 g/dL * ASAT and/or ALAT ≤ 2.5 x Upper Limit of Normal (ULN); patient with liver metastases ≤ 5 × ULN * Total bilirubin ≤ 1.5 x ULN * Creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min for patients with creatinine levels \> 1.5 x ULN (according to Cockroft-Gault Appendix D) ; * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN * Female patients with a negative highly sensitive pregnancy test, or postmenopausal female patients. Exclusion Criteria: * Patients with non-cutaneous melanoma, whether uveal, mucosal, of unknown primary origin or leptomeningeal * Patients who have received a minimum of one line of chemotherapy for melanoma treatment * Positive serology results for human immunodeficiency virus (HIV), active hepatitis B or C infection (acute or chronic) or uncontrolled infection * Concomitant presence or history of another malignancy, except for the following: appropriately treated squamous or basal cell carcinoma of the skin (adequate healing is required prior to study entry); any other solid tumor, curatively treated and without evidence of recurrence for at least 2 years prior to study entry. * Participation in or ongoing treatment with another investigational agent or use of an investigational device within 28 days prior to study treatment. NB: Participants who have entered the follow-up phase if an investigational study may participate as long as it has been 4 weeks or an interval of five-half-lives, whichever the shortest is, after the last dose of the previous investigational agent. * Subjects covered by Articles L1121-5 through L1121-8 of the Public Health Code (minors, adults under guardianship or conservatorship, patients deprived of their liberty, and pregnant or breastfeeding women). * Any pathology that, in the investigator's opinion, may be a contraindication to the patient's participation in the clinical study, for reasons of safety or compliance with clinical study procedures. * Patient with hypersensitivity to IMP temozolomide (including hypersensitivity to dacarbazine, severe myelosuppression) or to any of its excipients.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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