A Study to Assess YH003 in Combination With Pebolizumab and Albumin Paclitaxel Injection in Subjects With Unresectable/Metastatic Mucosal Melanoma

Study Overview
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Brief Summary
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This study is a multicenter, single-arm, open-label phase II study to assess the efficacy and safety of YH003 in combination with pembrolizumab and nab-paclitaxel in the first-line treatment of patients with unresectable/metastatic mucosal melanoma.

Official Title
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A Multicenter, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of YH003 in Combination With Pebolizumab and Albumin Paclitaxel in First-line Treatment of Patients With Unresectable/Metastatic Mucosal Melanoma

Conditions
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Mucosal Melanoma

Intervention / Treatment
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* Drug: YH003
* Drug: Pembrolizumab
* Drug: albumin paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Subjects must have the ability to understand and willingness to sign a written informed consent document. 2. Subjects must have histologically advanced or cytologically confirmed metastatic or unresectable mucosal melanoma; 3.Subjects have not received standard systemic therapy; patients have disease progression 6 months or more after the end of neoadjuvant or adjuvant therapy (except nab-paclitaxel), and can be enrolled in the clinical study; 4. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1; 5. Subjects must be age 18 years or older; 6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy ≥3 months based on investigator's judgement； 8. Subjects must have adequate organ function; 9. Women of childbearing potential need to have a negative pregnancy test and need to take contraceptive/contraceptive measures including their partners. Exclusion Criteria: 1.Subjects have another active invasive malignancy within 5 years； 2.The subject has received anti-tumor therapy or other investigational drug therapy or traditional Chinese medicine (herbal medicine) with anti-tumor indications prior to the first dose; 3.Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy. 4.History of clinically significant sensitivity or allergy ； 5.Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.； 6.History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease； 7.Subjects have active pulmonary embolism with hemodynamic changes 12 weeks before the first dose; 8. Subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment; 9. Subjects have clinically uncontrolled diseases; 10. Subjects have severe cardiovascular disease; 11. Subjects have evidence of active infection; 12. Subjects must not have a known or suspected history of an autoimmune disorder； 13.Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose. 14. Any condition that the investigator assesses as inappropriate for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/treatment<br>YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma | Drug: YH003<br>* YH003 will be administered intravenously over 30 minutes every 21-day cycle.<br>Drug: Pembrolizumab<br>* Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.<br>Drug: albumin paclitaxel<br>* Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Objective Response Rate (ORR) | Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | up to 2 years |