Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Ac… (NCT07501104) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma
30 participantsStarted 2026-05-01
Plain-language summary
This is a single-arm, open-label, single-center, Phase II exploratory clinical study evaluating the efficacy, safety, and tolerability of neoadjuvant pucotenlimab combined with lenvatinib and temozolomide in patients with resectable Stage IIB/III acral melanoma.
After providing written informed consent, eligible subjects will receive neoadjuvant combination therapy consisting of pucotenlimab, lenvatinib, and temozolomide, with each treatment cycle lasting 3 weeks. Surgical resection will be performed after 3 cycles of treatment. Postoperative adjuvant therapy will be determined based on the pathological results of the surgical specimens. Subjects who do not achieve a major pathological response (MPR) will receive pucotenlimab maintenance therapy for a total of 1 year, while subjects who achieve an MPR will be exempt from adjuvant therapy.
Treatment will continue until the completion of adjuvant therapy, disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or discontinuation determined by the investigator, whichever occurs first.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fully understand the study and voluntarily sign the informed consent form (ICF). (Note: Items 1 and 10 are similar, but both are translated here) Age ≥ 18 and ≤ 75 years old. Histologically or cytologically confirmed resectable Stage IIB-III melanoma. Have at least one measurable lesion according to RECIST 1.1 criteria. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
Life expectancy of ≥ 6 months. No prior systemic drug therapy for melanoma.
Adequate major organ function meeting the following criteria:
Hematology (without blood transfusion or use of hematopoietic stimulating factors within 14 days): Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5×10\^9/L; Platelets (PLT) ≥ 100×10\^9/L; White Blood Cell (WBC) count ≥ 3.0×10\^9/L.
Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (upper limit of normal) (for patients with liver metastasis, ≤ 5 × ULN); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (for patients with Gilbert's syndrome, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 50 ml/min.
Coagulation: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), and Prothrombin Time (PT) ≤ 1.5 × ULN.
Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%. Women of childbearing potential must agree to use acceptable methods of contraception (e.g., intrauterine device \[IUD\], oral con…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Pathological Response (MPR) Rate
Timeframe: Up to the time of surgery (assessed approximately 9-10 weeks after the start of neoadjuvant therapy)