Tunlametinib for NRAS‑mutant advanced melanoma after PD‑1/PD‑L1 therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open‑label, multicenter real‑world study planning to enroll about 110 adults with histologically or cytologically confirmed NRAS‑mutant locally advanced or metastatic melanoma who have failed prior anti‑PD‑1/PD‑L1 therapy. Participants will take tunlametinib 12 mg orally twice daily in continuous 4‑week cycles, with dose adjustments allowed for toxicity. Treatment continues until confirmed disease progression, intolerable toxicity, initiation of new anti‑tumor therapy, withdrawal of consent, death, or investigator decision, and survival follow‑up continues after discontinuation. Eligibility is confirmed during a screening period up to 28 days before enrollment and safety visits are included during follow‑up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged ≥18 years (inclusive), male or female;
* Patients with histologically or cytologically confirmed locally advanced or metastatic melanoma;
* Prior genetic testing results showing positive NRAS mutation;
* Patients who have failed prior anti-PD-1/PD-L1 therapy;
* Able to take oral medications;
* Voluntarily participate and sign the informed consent form, expected to have good compliance, and able to cooperate with the study according to the protocol requirements.

Exclusion Criteria:

* Currently participating in other clinical trials of drugs;
* Patients who are pregnant or breastfeeding;
* Other conditions deemed unsuitable for targeted therapy after multidisciplinary discussion;
* Other conditions considered inappropriate for inclusion by the investigator, such as familial or social factors that may affect the safety of the subject or the collection of data.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yu Wang
• Email: neck130@sina.com
• Phone: 86-021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combo of tunlametinib, pucotenlimab, and hydroxychloroquine in NRAS-mutant melanoma

  This study tests whether adding hydroxychloroquine to tunlametinib and pucotenlimab helps people with NRAS-mutant melanoma.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07750067

• Fiber to boost gut bacteria and immunotherapy response in advanced melanoma

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  Recruiting Phase 2 Radboud University Medical Center · Nijmegen, Gelderland and 1 other locations · NCT07686835

• Tunlametinib for NRAS‑mutant non‑melanoma refractory solid tumors

  This trial tests tunlametinib to see if it can shrink or control advanced non‑melanoma solid tumors that have NRAS mutations in patients who have failed standard treatments.

  Recruiting Phase 2 Tianjin Medical University Second Hospital · Tianjin, Tianjin Municipality · NCT07170293

• Tunlametinib for advanced NRAS‑mutant thyroid cancer

  This trial tests whether the MEK inhibitor tunlametinib, alone or with a PD‑1 immunotherapy, can shrink or control tumors in adults with advanced NRAS‑mutant thyroid cancer that is refractory to radioactive iodine.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06970353

• Assessing a test to predict treatment response in advanced melanoma patients

  This study tests if the IOpener® melanoma test can help predict how well treatment will work for people with advanced melanoma who are starting their first-line therapy.

  Recruiting at 3 sites Pamgene International B.V. · Tübingen, Baden-Wurttemberg and 2 other locations · NCT06784778

• Comparing tunlametinib capsules with chemotherapy for advanced NRAS-mutant melanoma

  This study is testing if tunlametinib capsules can work better than standard chemotherapy for people with advanced melanoma that has NRAS mutations and who have already tried immunotherapy.

  Recruiting Phase 3 Shanghai Kechow Pharma, Inc. · Beijing, Beijing Municipality · NCT06008106

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.