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

Mucosal Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420324
• Other study ID #: YH003006
• Status: Recruiting
• Phase: Phase 2
• Start date: June 13, 2022
• Est. completion date: September 2025

Study information

• Verified date: June 2022
• Source: Eucure (Beijing) Biopharma Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: September 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Mucosal Melanoma

Intervention

Drug:
• YH003
YH003 will be administered intravenously over 30 minutes every 21-day cycle.
• Pembrolizumab
Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.
• albumin paclitaxel
Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Cancer Hospital of Fujian	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Cancer Hospital of The University of Chinese Academy of Sciences	Hangzhou	Zhenjiang
China	The First Hospital of Jilin University	Jilin	Jilin
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	Nanjing Drum Tower Hospital	Nanjing	Nanjing
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Cancer Hospital of Zhenzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Eucure (Beijing) Biopharma Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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