Neoadjuvant paclitaxel polymersomes with carboplatin and adebrelimab for resectable mucosal melanoma

A Single-Arm, Phase Ⅱ Exploratory Study of Neoadjuvant Therapy With Paclitaxel Polymersomes for Injection Combined With Carboplatin and Adebelimab in the Treatment of Resectable Mucosal Melanoma

This trial tests whether giving paclitaxel polymersomes together with carboplatin and adebrelimab before surgery helps people with resectable mucosal melanoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, adebrelimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07336979 on ClinicalTrials.gov

What this trial studies

Patients with resectable mucosal melanoma will receive three 3-week cycles of paclitaxel polymersomes, carboplatin, and adebrelimab prior to curative surgery. After completing three cycles, participants undergo surgery and pathologists evaluate the resected tissue for pathological response. Immunohistochemical assays will measure immune activation within the tumor microenvironment. The primary endpoint is pathological response rate and entry requires ECOG 0–1, measurable disease, no prior checkpoint inhibitor or taxane therapy, and adequate organ function.

Who should consider this trial

Good fit: Adults with histologically confirmed, resectable mucosal melanoma who are ECOG 0–1, treatment-naive to checkpoint inhibitors and taxanes, have measurable disease, and can provide pre-treatment tissue are the ideal candidates.

Not a fit: Patients with unresectable disease, prior treatment with immune checkpoint inhibitors or taxanes, poor organ function, or ECOG performance status >1 are unlikely to benefit from this neoadjuvant approach.

Why it matters

Potential benefit: If successful, the regimen could increase tumor shrinkage before surgery and improve long-term outcomes for patients with resectable mucosal melanoma.

How similar studies have performed: Neoadjuvant combinations of chemotherapy with PD-1/PD-L1 blockade have shown activity in some cancers, but paclitaxel polymersomes are a novel formulation and this exact combination in mucosal melanoma is relatively untested.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: xizhiwen wen

Conditions Resectable Mucosal Melanoma