BridgeMD
New treatment option for Resectable Mucosal Melanoma
Official title Paclitaxel Polymersomes + Carboplatin + Adebelimab: Neoadjuvant Phase Ⅱ Single-Arm Study for Resectable Mucosal Melanoma
ClinicalTrials.gov ID: NCT07336979
What this study is testing
What is Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab?
Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for resectable mucosal melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the pathological response rate of neoadjuvant therapy with paclitaxel polymersomes for injection combined with carboplatin and adebrelimab in patients with resectable mucosal melanoma.Subjects will receive the combination therapy of paclitaxel polymersomes for injection, carboplatin and adebrelimab prior to surgery, with a treatment cycle of 3 weeks and a total of 3 cycles.After completing 3 cycles of treatment, subjects will undergo curative surgery. Pathologists will evaluate the surgically resected specimens to determine the status of pathological response, and immunohistochemical assays will be performed to assess the intensity of immune activation within the tumor microenvironment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old.
- Histopathologically confirmed resectable mucosal melanoma.
- people must provide 5 formalin-fixed paraffin-embedded (FFPE) tissue sections collected before treatment, or be willing to undergo needle biopsy for...
- ECOG (Performance Status, PS) score of 0-1.
- No prior treatment with immune checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies.
You likely can't join if
- Presence of distant metastatic lesions.
- Active autoimmune disease. Note: Patients with vitiligo, type 1 diabetes mellitus, or Hashimoto's thyroiditis with hypothyroidism who only require...
- Need for systemic corticosteroid therapy (\> 10 mg prednisolone [or equivalent]/daily) or other immunosuppressant use within 14 days after...
- Concurrent diagnosis of other malignant tumors requiring anti-tumor treatment. Note: Patients may be considered for enrollment if the other malignant...
- Patients who are medically, psychologically, or physically unable to complete the study or understand the information provided in the patient...
- 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.
See the full eligibility criteria
- Age ≥ 18 years old.
- Histopathologically confirmed resectable mucosal melanoma.
- people 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.
- ECOG (Performance Status, PS) score of 0-1.
- No prior treatment with immune checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies.
- No prior treatment with taxane-based drugs.
- Presence of measurable lesions (per RECIST 1.1 criteria).
- No history of immunosuppressant use within 6 months prior to enrollment.
- 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...
- 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).
- Presence of distant metastatic lesions.
- 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...
- 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...
- 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...
- 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.
- 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.
- Prior chemotherapy with taxane-based drugs.
- Positive HIV test result or confirmed diagnosis of acquired immunodeficiency syndrome (AIDS).
- Known hypersensitivity to the study drugs.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.