New drug cocktail aims to shrink melanoma before surgery
NCT ID NCT07336979
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether giving a combination of chemotherapy (paclitaxel polymersomes and carboplatin) plus an immunotherapy drug (adebelimab) before surgery can help shrink tumors in people with resectable mucosal melanoma. About 32 participants will receive up to 3 cycles of treatment, then undergo surgery to remove any remaining cancer. The main goal is to see how many patients have a significant reduction in tumor cells after the drug combo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel polymersomes, carboplatin, and adebelimab
- What this could lead to
- If successful, this approach could shrink tumors before surgery, potentially improving survival and reducing recurrence for people with resectable mucosal melanoma.
- What could go wrong
- This is a small, early-phase trial with only 32 participants, so results may not apply to everyone. The drug combination may cause side effects like nerve damage, low blood counts, or immune-related reactions.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Age ≥ 18 years old. 2. Histopathologically confirmed resectable mucosal melanoma. 3. Subjects must provide 5 formalin-fixed paraffin-embedded (FFPE) tissue sections collected before treatment, or be willing to undergo needle biopsy for pathological tissue acquisition to facilitate pathological assessment. 4. ECOG (Performance Status, PS) score of 0-1. 5. No prior treatment with immune checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies. 6. No prior treatment with taxane-based drugs. 7. Presence of measurable lesions (per RECIST 1.1 criteria). 8. No history of immunosuppressant use within 6 months prior to enrollment. 9. Hematological and biochemical test results meeting the following criteria: i. Neutrophil count ≥ 1,500 × 10⁹/L; ii. Platelet count ≥ 100 × 10⁹/L; iii. Hemoglobin \> 9.0 g/dL; iv. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min; v. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 3 × ULN; vi. Total bilirubin ≤ 1.5 × ULN. 10. Women of childbearing potential must have a negative serum or urine pregnancy test and agree to use an appropriate contraceptive method (barrier contraception or oral contraceptives). Exclusion Criteria: 1. Presence of distant metastatic lesions. 2. Active autoimmune disease. Note: Patients with vitiligo, type 1 diabetes mellitus, or Hashimoto's thyroiditis with hypothyroidism who only require hormone replacement therapy may be enrolled if there is no evidence of significant disease recurrence. 3. Need for systemic corticosteroid therapy (\> 10 mg prednisolone \[or equivalent\]/daily) or other immunosuppressant use within 14 days after enrollment. Note: Inhaled or topical corticosteroids, or adrenal hormone replacement therapy (\> 10 mg prednisolone \[or equivalent\]/daily) are acceptable for patients without obvious autoimmune diseases. 4. Concurrent diagnosis of other malignant tumors requiring anti-tumor treatment. Note: Patients may be considered for enrollment if the other malignant tumor has achieved complete remission for 2 years or more and no additional anti-tumor treatment is required during the study period. 5. Patients who are medically, psychologically, or physically unable to complete the study or understand the information provided in the patient brochure, as assessed by the investigator. 6. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other drugs targeting T-cell costimulatory or immune regulatory pathways. 7. Prior chemotherapy with taxane-based drugs. 8. Positive HIV test result or confirmed diagnosis of acquired immunodeficiency syndrome (AIDS). 9. Known hypersensitivity to the study drugs. 10. Pregnant or lactating women.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Resectable mucosal melanoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
Contacts and locations
Locations
-
Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510000, China