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Completed

NCT Number: NCT05420324

A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital of Fujian, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YH003

Drug

YH003 will be administered intravenously over 30 minutes every 21-day cycle.

Pembrolizumab

Drug

Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.

albumin paclitaxel

Drug

Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.

Primary outcomes

  1. Confirmed Objective Response Rate (ORR)

    Time frame: up to 2 years

    Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Sponsors and collaborators

Lead sponsor

Eucure (Beijing) Biopharma Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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