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

NCT05420324 | Completed Phase 2 DMC

• 1 other identifier: YH003006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 12

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.

Conditions

Mucosal Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

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

Drug: YH003; Drug: Pembrolizumab; Drug: albumin paclitaxel

Interventions

YH003 DRUG

YH003 will be administered intravenously over 30 minutes every 21-day cycle.

Intervention/treatment

Pembrolizumab DRUG

Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.

Intervention/treatment

albumin paclitaxel DRUG

Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.

Intervention/treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have the ability to understand and willingness to sign a written informed consent document.
• \. Subjects must have histologically advanced or cytologically confirmed metastatic or unresectable mucosal melanoma;
• 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;
• \. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1;
• \. Subjects must be age 18 years or older;
• \. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• \. Life expectancy ≥3 months based on investigator's judgement；
• \. Subjects must have adequate organ function;
• \. Women of childbearing potential need to have a negative pregnancy test and need to take contraceptive/contraceptive measures including their partners.

You may not qualify if:

• Subjects have another active invasive malignancy within 5 years；
• 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;
• Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy.
• History of clinically significant sensitivity or allergy ；
• Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.；
• History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease；
• Subjects have active pulmonary embolism with hemodynamic changes 12 weeks before the first dose;
• \. Subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment;
• \. Subjects have clinically uncontrolled diseases;
• \. Subjects have severe cardiovascular disease;
• \. Subjects have evidence of active infection;
• \. Subjects must not have a known or suspected history of an autoimmune disorder；
• Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose.
• \. Any condition that the investigator assesses as inappropriate for participation in the study.

Sponsors & Collaborators

• Eucure (Beijing) Biopharma Co., Ltd: lead

Study Sites (12)

Cancer Hospital of Fujian

Fuzhou, Fujian, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Cancer Hospital of Zhenzhou

Zhengzhou, Henan, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

The First Hospital of Jilin University

Jilin, Jilin, China

Location

The First affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Nanjing Drum Tower Hospital

Nanjing, Nanjing, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, China

Location

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, zhenjiang, China

Location

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 15, 2022
• Study Start: June 13, 2022
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)