NCT05420324CompletedPhase 2
A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma
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
Source: ClinicalTrials.gov · Last updated 6 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 7 Jun 2022
- Start date
- 13 Jun 2022
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- Eucure (Beijing) Biopharma Co., Ltd
- Diseases
- Melanoma
- NCT number
- NCT05420324
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 13 Jun 2022 to the primary completion date, 4 Mar 2024
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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;
- 13.Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose.
Other illness
- 1.Subjects have another active invasive malignancy within 5 years;
- 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;
- 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;
- 14\. Any condition that the investigator assesses as inappropriate for participation in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Cancer Hospital of Fujian Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Cancer Hospital of The University of Chinese Academy of Sciences Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Cancer Hospital of Zhenzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.