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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2024-03-04

Brief Summary

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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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Detailed Description

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Conditions

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Mucosal Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention/treatment

YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma

Group Type EXPERIMENTAL

YH003

Intervention Type DRUG

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

Pembrolizumab

Intervention Type DRUG

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

albumin paclitaxel

Intervention Type DRUG

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

Interventions

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YH003

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

Intervention Type DRUG

Pembrolizumab

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

Intervention Type DRUG

albumin paclitaxel

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No