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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

1.Subjects must have the ability to understand and willingness to sign a written informed consent document.
1. 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;
1. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1;
1. Subjects must be age 18 years or older;
1. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
1. Life expectancy ≥3 months based on investigator's judgement；
1. Subjects must have adequate organ function;
1. 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;
1. Subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment;
1. Subjects have clinically uncontrolled diseases;
1. Subjects have severe cardiovascular disease;
1. Subjects have evidence of active infection;
1. 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.
1. Any condition that the investigator assesses as inappropriate for participation in the study.

Arm && Interventions

Group	Intervention	Description
Intervention/treatment	YH003	YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
Intervention/treatment	Pembrolizumab	YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
Intervention/treatment	albumin paclitaxel	YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma

Primary Outcome Measures

Name	Time	Method
Confirmed Objective Response Rate (ORR)	up to 2 years	Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Name	Time	Method

Locations (12): Cancer Hospital of Fujian
🇨🇳
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳
Guangzhou, Guangdong, China
Cancer Hospital of Zhenzhou
🇨🇳
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳
Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳
Changsha, Hunan, China
The First Hospital of Jilin University
🇨🇳
Jilin, Jilin, China
The First affiliated Hospital of Dalian Medical University
🇨🇳
Dalian, Liaoning, China
Nanjing Drum Tower Hospital
🇨🇳
Nanjing, Nanjing, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳
Tianjin, Tianjin, China
Yunnan Cancer Hospital
🇨🇳
Kunming, Yunnan, China
West China Hospital of Sichuan University
🇨🇳
Chengdu, Sichuan, China
Cancer Hospital of The University of Chinese Academy of Sciences
🇨🇳
Hangzhou, zhenjiang, China