A Phase II Study of Nab-Paclitaxel Combined With Retlirafusp Alfa and Apatinib in Patients With Advanced Mucosal Melanoma

November 8, 2026 updated by: xizhi wen, Sun Yat-sen University

A Prospective, Single-Arm, Phase II Study of Nab-Paclitaxel Combined With Retlirafusp Alfa Injection and Apatinib Mesylate for Advanced Mucosal Melanoma

This is a prospective, single-arm, open-label Phase II clinical study. The main purpose of this study is to evaluate the effectiveness of nab-paclitaxel combined with retlirafusp alfa injection and apatinib mesylate in patients with advanced mucosal melanoma.

Participants will receive treatment with nab-paclitaxel combined with retlirafusp alfa injection and apatinib mesylate. Each treatment cycle lasts 3 weeks, and participants will receive a total of 6 cycles. Participants whose disease does not progress after the initial treatment will continue maintenance therapy with apatinib mesylate combined with retlirafusp alfa injection until their disease progresses or they experience intolerable side effects.

After enrollment, participants will undergo safety visits before each dose on Day 1 and Day 21 of each treatment cycle. Tumor imaging assessments will be performed before treatment and after every 2 to 4 cycles of treatment. Clinical response will be evaluated by radiologists according to the RECIST 1.1 criteria.

Researchers will monitor participants for any adverse events throughout the study and will grade the severity of these events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. After treatment is completed, participants will be followed for 12 weeks for safety monitoring, and long-term survival follow-up will continue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Xiaoshi Zhang, phD

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun yat-sen uniersity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years.

  2. Histopathologically confirmed unresectable or metastatic mucosal melanoma.

  3. Subjects must provide 5 paraffin-embedded tissue sections obtained prior to treatment for immune microenvironment (immune infiltration) scoring.

  4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States has a score range of 0-1.

  5. No prior systemic therapy. Patients who developed recurrence or metastasis more than 6 months after discontinuation of adjuvant therapy are excluded from this criterion (i.e., such patients are eligible).

  6. Presence of at least one measurable lesion according to RECIST 1.1 criteria.

  7. No history of immunosuppressive drug use within 6 months prior to enrollment.

  8. Adequate hematologic and organ function, meeting the following laboratory criteria:

    i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; ii. Platelet count ≥ 100 × 10⁹/L; iii. Hemoglobin > 9.0 g/dL; iv. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 40 mL/min; v. AST/ALT ≤ 3 × ULN; vi. Total bilirubin ≤ 1.5 × ULN.

  9. No active bleeding.

  10. Urine protein ≤ 1+ or < 1 g/24h.

  11. Women of childbearing potential must have a negative serum or urine pregnancy test and agree to use adequate contraception (barrier method or oral contraceptives) during the study.

Exclusion Criteria:

  1. Patients with active autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, or hypothyroidism due to Hashimoto's thyroiditis requiring only hormone replacement therapy may be enrolled if there is no obvious evidence of recurrence.
  2. Patients requiring systemic corticosteroid therapy (> 10 mg prednisone [or equivalent] per day) or other immunosuppressive agents within 14 days after enrollment. Note: Inhaled or topical corticosteroids, or adrenal hormone replacement therapy (> 10 mg prednisone [or equivalent] per day) are acceptable for patients without obvious autoimmune disease.
  3. Patients with concurrent other malignancy requiring anti-tumor therapy cannot be enrolled in this study. However, if the malignancy has achieved complete remission for two years or more, and no additional anti-tumor therapy is required during the study period, enrollment may be considered.
  4. Patients who, in the investigator's judgment, are medically, psychologically, or physiologically unable to complete this study or to understand the patient information.
  5. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-TGF-β, or other agents targeting T-cell co-stimulatory or immune regulatory pathways.
  6. Prior treatment with taxanes, platinum-based agents, or anti-angiogenic agents.
  7. Presence of untreated CNS metastases, or CNS metastases requiring corticosteroids for edema control.
  8. Tumor invasion of major blood vessels (e.g., carotid artery, aorta), concurrent active ulcer, or history of gastrointestinal bleeding.
  9. History of myocardial infarction or stroke within the past 6 months.
  10. Positive HIV test or confirmed diagnosis of acquired immunodeficiency syndrome (AIDS).
  11. Uncontrolled hypertension, commonly defined as: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or requiring ≥ 2 antihypertensive agents without achieving target.
  12. Cardiac arrhythmias requiring pharmacological or device intervention, affecting hemodynamic stability, or posing a risk of sudden death, including but not limited to uncontrolled rapid atrial fibrillation, ventricular tachycardia, atrioventricular block, and QTc ≥ 500 ms.
  13. Uncontrolled heart failure, defined as NYHA class III-IV, or persistent significant symptoms despite optimized therapy, or recent need for hospitalization or intravenous therapy, or significantly reduced left ventricular ejection fraction (e.g., < 40-50%).
  14. Patients with a history of severe (≥ G3) immune-related adverse events (irAEs) involving major organs, such as immune-mediated hepatitis, pneumonitis, myocarditis, colitis, or central nervous system toxicity.
  15. Presence of unhealed wounds.
  16. Allergy to the study drug or its components.
  17. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Assigned Interventions

Drug: Nab-paclitaxel Injection Nab-paclitaxel 200 mg/m² IV infusion Q3W

Drug: Retlirafusp Alfa Injection Retlirafusp Alfa 1 diluted in 250 mL normal saline IV, administered 30 minutes before chemotherapy, Q3W

Drug: Apatinib Mesylate Tablet Apatinib Mesylate 250 mg PO QD

Regimen: Nab-paclitaxel + Retlirafusp Alfa + Apatinib Mesylate, Q3W × 6 cycles (combination phase); maintenance: Apatinib Mesylate + Retlirafusp Alfa until disease progression or unacceptable toxicity
Drug: Retlirafusp Alfa Injection

Drug: Nab-paclitaxel Injection Nab-paclitaxel 200 mg/m² IV infusion Q3W

Drug: Retlirafusp Alfa Injection Retlirafusp Alfa diluted in 250 mL normal saline IV, administered 30 minutes before chemotherapy, Q3W

Drug: Apatinib Mesylate Tablet Apatinib Mesylate 250 mg PO QD

Regimen: Nab-paclitaxel + Retlirafusp Alfa + Apatinib Mesylate, Q3W × 6 cycles (combination phase); maintenance: Apatinib Mesylate + SHR-1701 until disease progression or unacceptable toxicit

Other Names:
  • Nab-paclitaxel Injection
  • Apatinib Mesylate Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR: CR+PR)
Time Frame: up to 18 weeks

defined as the best overall response of complete remission or partial remission
up to 18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AEs+SAEs
Time Frame: from the first drug administration to within 30 days for the last SHR-1701 dose

Adverse Events and Serious Adverse Events
from the first drug administration to within 30 days for the last SHR-1701 dose
overall survival（OS）
Time Frame: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years

defined as the time from enrollment to death due to any cause
Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years
progress-free survival（RFS）
Time Frame: Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years

Defined as the time from enrollment to the first documented disease progression, death from any cause, or the last date on which the patient was recorded as being free of disease progression.
Assessed until 12 months after the first dose of the last enrolled patient, estimated up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2026-345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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