Phase
Condition
Melanoma
Treatment
albumin paclitaxel
YH003
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
1.Subjects must have the ability to understand and willingness to sign a writteninformed consent document.
- Subjects must have histologically advanced or cytologically confirmedmetastatic or unresectable mucosal melanoma;
3.Subjects have not received standard systemic therapy; patients have diseaseprogression 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) performancestatus 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 needto take contraceptive/contraceptive measures including their partners.
Exclusion
Exclusion Criteria:
1.Subjects have another active invasive malignancy within 5 years;
2.The subject has received anti-tumor therapy or other investigational drug therapyor traditional Chinese medicine (herbal medicine) with anti-tumor indications priorto the first dose;
3.Subjects with a history of ≥ Grade 3 immune-related adverse events resulted fromprevious 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 currentpneumonitis, or history of interstitial lung disease;
7.Subjects have active pulmonary embolism with hemodynamic changes 12 weeks beforethe first dose;
- Subjects must not have a known or suspected history of autoimmune diseasewithin 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;
13.Major surgery within 4 weeks prior to study entry and Minor surgery within 2weeks prior to the first dose.
- Any condition that the investigator assesses as inappropriate for participationin the study.
Study Design
Connect with a study center
Cancer Hospital of Fujian
Fuzhou, Fujian
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaSite Not Available
Cancer Hospital of Zhenzhou
Zhengzhou, Henan
ChinaSite Not Available
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan
ChinaSite Not Available
The First Hospital of Jilin University
Jilin, Jilin
ChinaSite Not Available
The First affiliated Hospital of Dalian Medical University
Dalian, Liaoning
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Nanjing
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin
ChinaSite Not Available
Yunnan Cancer Hospital
Kunming, Yunnan
ChinaSite Not Available
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, zhenjiang
ChinaSite Not Available

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