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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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
The First Affiliated Hospital of Dalian Medical University
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DalianChinaUnknown status
Cancer Hospital of Fujian
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FuzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Cancer Hospital of The University of Chinese Academy of Sciences
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HangzhouChinaUnknown status
The First Hospital of Jilin University
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Jilin CityChinaUnknown status
Yunnan Cancer Hospital
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KunmingChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Cancer Hospital of Zhenzhou
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.