A Study to Assess YH003 in Combination With Pebolizumab and Albumin Paclitaxel Injection in Subjects With Unresectable/Metastatic Mucosal Melanoma
Primary Purpose
Mucosal Melanoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
YH003
Pembrolizumab
albumin paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Cancer Hospital of Fujian
- Sun Yat-sen University Cancer Center
- Cancer Hospital of Zhenzhou
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Hunan Cancer HospitalRecruiting
- The First Hospital of Jilin University
- The First affiliated Hospital of Dalian Medical University
- Nanjing Drum Tower Hospital
- West China Hospital of Sichuan University
- Tianjin Medical University Cancer Institute and HospitalRecruiting
- Yunnan Cancer Hospital
- Cancer Hospital of The University of Chinese Academy of Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention/treatment
Arm Description
YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05420324
First Posted
June 7, 2022
Last Updated
October 8, 2022
Sponsor
Eucure (Beijing) Biopharma Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05420324
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eucure (Beijing) Biopharma Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucosal Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention/treatment
Arm Type
Experimental
Arm Description
YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
Intervention Type
Drug
Intervention Name(s)
YH003
Intervention Description
YH003 will be administered intravenously over 30 minutes every 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
albumin paclitaxel
Intervention Description
Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.
Primary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR)
Description
Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cancer Hospital of Fujian
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ling chen
Phone
13960828743
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ya ding
Phone
13824454838
Email
dingya@sysucc.org.cn
Facility Name
Cancer Hospital of Zhenzhou
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yan wang
Phone
13592691213
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
li fan
Phone
15927574289
Email
chenjingunion@163.com
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xingxiang pu
Phone
15874180022
Email
pxx_1354@163.com
Facility Name
The First Hospital of Jilin University
City
Jilin
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhen guo
Phone
15843073215
Email
wudi991202@163.com
Facility Name
The First affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiwei liu
Phone
18098877966
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lianjun zhao
Phone
15951956162
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yu jiang
Phone
18980601130
Email
jiangyuwork@126.com
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiubao ren
Phone
13820602901
Email
xiubao_ren@126.com
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chunlei ge
Phone
18980601130
Email
jiangyuwork@126.com
Facility Name
Cancer Hospital of The University of Chinese Academy of Sciences
City
Hangzhou
State/Province
Zhenjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
meiyu fang
Phone
13750851650
Email
fangmy@zjcc.org.cn
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess YH003 in Combination With Pebolizumab and Albumin Paclitaxel Injection in Subjects With Unresectable/Metastatic Mucosal Melanoma
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