Mucosal MelanomaPhase 2NCT05420324
A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma
A Phase 2 study testing YH003, Pembrolizumab and albumin paclitaxel in people with Mucosal Melanoma, run by Eucure (Beijing) Biopharma Co., Ltd at 12 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- YH003, Pembrolizumab and albumin paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 12 sitesChina
- Study dates
- 13 Jun 2022to 4 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Hunan Cancer Hospital
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
The First affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Cancer Hospital of Fujian
Fuzhou, Fujian
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, zhenjiang
The First Hospital of Jilin University
Jilin City, Jilin
Yunnan Cancer Hospital
Kunming, Yunnan
Nanjing Drum Tower Hospital
Nanjing, Nanjing
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Cancer Hospital of Zhenzhou
Zhengzhou, Henan
About this study
Official 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
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.
- Conditions
- Mucosal Melanoma
- Being tested
- YH003, Pembrolizumab, albumin paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH003Drug
YH003 will be administered intravenously over 30 minutes every 21-day cycle.
PembrolizumabDrug
Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.
albumin paclitaxelDrug
Albumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma Receives: Drug: YH003; Drug: Pembrolizumab; Drug: albumin paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR)
Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start13 Jun 2022
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eucure (Beijing) Biopharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420324
- Sponsor's protocol ID
- YH003006
- Status last verified
- Jan 2025
- First submitted
- 7 Jun 2022
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05420324
- Acronym / sponsor ID
- YH003006
- Conditions
- Mucosal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eucure (Beijing) Biopharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Drug: YH003, Drug: Pembrolizumab, Drug: albumin paclitaxelYH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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.；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH003YH003 will be administered intravenously over 30 minutes every 21-day cycle. | Drug | Intervention/treatment |
| PembrolizumabPembrolizumab will be administered intravenously over 30 minutes every 21-day cycle. | Drug | Intervention/treatment |
| albumin paclitaxelAlbumin paclitaxel will be administered intravenously over 30 minutes every 21-day cycle. | Drug | Intervention/treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YH003, Pembrolizumab and albumin paclitaxel in people with Mucosal Melanoma, run by Eucure (Beijing) Biopharma Co., Ltd at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (ORR) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.