Clinical trial NCT05420324: A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucosal Melanoma
Lead sponsor: Eucure (Beijing) Biopharma Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Confirmed Objective Response Rate (ORR)
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Cancer Hospital of Fujian
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Cancer Hospital of Zhenzhou
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Jilin
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First affiliated Hospital of Dalian Medical University
state: Liaoning
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Nanjing
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Cancer Hospital of The University of Chinese Academy of Sciences
state: zhenjiang
Study officials:
References: