Acral MelanomaPhase 2NCT07347444
Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel, and Carboplatin as First- or Second-line Treatment for Patients With Advanced Acral and Mucosal Melanoma
A Phase 2 study testing Iparomlimab and Tuvoraleimab injection+Bev+nab-PC in people with Acral Melanoma and Mucosal Melanoma, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab, in combination with bevacizumab, albumin-bound paclitaxel, and carboplatin as first- or second-line treatment in patients with acral and mucosal melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acral Melanoma, Mucosal Melanoma
- What is being tested?
- Iparomlimab and Tuvoraleimab injection+Bev+nab-PC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects (or their legal representatives/guardians) must sign the informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures involved, and are willing to participate.
- Aged ≥18 years and ≤75 years, regardless of gender.
- Histologically or pathologically confirmed mucosal or acral melanoma.
- Braf, Nras, and Ckit gene mutation status is unrestricted.
- Unresectable or metastatic melanoma, having received ≤1 prior line of systemic therapy (disease recurrence or metastasis within 6 months after completion of adjuvant therapy is considered as first-line therapy).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.
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- Expected survival of more than 3 months.
- At least one measurable lesion according to RECIST v1.1. Note: Brain metastases cannot serve as target lesions; Lesions previously treated with radiotherapy cannot serve as target lesions unless imaging demonstrates clear progression.
- Laboratory test results within 7 days prior to screening (including day 7) must meet the following criteria: Neutrophil count ≥1.5×10⁹/L; Platelet count ≥90×10⁹/L; Hemoglobin ≥90 g/L (without transfusion within 14 days); Serum total bilirubin ≤1.25 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (≤5 × ULN for patients with liver metastases); Serum creatinine ≤1.25 × ULN.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test result is not conclusively negative, a serum pregnancy test is required, and the serum result shall prevail). If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, she must use acceptable contraceptive methods starting from screening and must agree to continue their use for 120 days after the last dose of the study drug; whether to discontinue contraception after this time point should be discussed with the investigator.
- If a non-sterilized male subject engages in sexual activity with a female partner of childbearing potential, he must use effective contraceptive methods from screening until 120 days after the last dose; whether to discontinue contraception after this time point should be discussed with the investigator.
- Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
Who cannot join
- History or presence of other malignancies within the past 5 years, except for cured localized tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, etc.).
- Participation in treatment with an investigational drug or use of an investigational device within 4 weeks prior to the first dose of study treatment.
- Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks prior to the first dose; Treatment with Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose.
- Patients who have previously received iparomlimab and tuvoraleimab or other dual immunotherapy, bevacizumab, albumin-bound paclitaxel, or carboplatin.
- Active autoimmune disease that has required systemic treatment in the past two years (i.e., with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- History of active or documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea.
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- History of immunodeficiency; Positive HIV antibody test; Current long-term use of systemic corticosteroids or other immunosuppressive agents.
- Known active tuberculosis (TB); Subjects suspected of having active TB must undergo clinical evaluation to rule it out; Known active syphilis infection.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- History of non-infectious pneumonitis/interstitial lung disease that required systemic corticosteroid treatment or current presence of non-infectious pneumonitis.
- Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C).
- Subjects with active hepatitis B (HBsAg positive and HBV-DNA >1000 copies/mL [200 IU/mL] or above the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive anti-hepatitis B virus therapy during the study treatment.
- Subjects with active hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection).
- Major surgical procedure or significant traumatic injury within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (at the investigator's discretion); Minor local surgery (excluding peripherally inserted central catheter placement and port implantation) within 3 days prior to the first dose.
- Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases are eligible if clinically stable for at least 2 weeks (calculated from the first dose of study drug) and off corticosteroids for at least 3 days prior to the first dose; Subjects with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, and no lesion with longest diameter >1.5 cm) are eligible and require periodic assessment during the study.
- Known brainstem, leptomeningeal, spinal cord metastases, or spinal cord compression.
- Subjects with clinically symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
- Uncontrolled concurrent illness, including but not limited to symptomatic congestive heart failure (NYHA Class II or higher), unstable angina pectoris, acute myocardial ischemia, poorly controlled arrhythmias, decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the subject's ability to provide written informed consent.
- History of myocarditis, cardiomyopathy, or malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure (NYHA Class II or higher), or vascular disease (e.g., aortic aneurysm at risk of rupture) requiring hospitalization within 12 months prior to the first dose, or other cardiac impairment that may affect safety evaluation of the study drug (e.g., poorly controlled arrhythmia, myocardial ischemia); History of esophageal/gastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal hemorrhage within 6 months prior to the first dose; Acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose; Any arterial thromboembolic event, Grade 3 or higher venous thromboembolism per NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; Current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive medication.
- Current significant clinical or imaging evidence of gastrointestinal obstruction.
- History of severe bleeding tendency or coagulation dysfunction; Imaging at screening shows tumor encasement of major blood vessels or significant necrosis/cavitation, and the investigator considers participation may pose a bleeding risk.
- Subjects with tumor invasion of surrounding vital organs or blood vessels (e.g., heart/pericardium, trachea, esophagus, aorta, superior vena cava, etc.), at risk of developing tracheoesophageal fistula, esophagopleural fistula, or enteric fistula, etc.
- Toxicities from prior anti-tumor therapy have not resolved to ≤ Grade 1 per NCI CTCAE v5.0 or to levels specified in the inclusion/exclusion criteria, except for alopecia and residual neuropathy from prior platinum therapy. Subjects with irreversible toxicity not expected to exacerbate with study treatment (e.g., hearing loss) may be included after consultation with the Medical Monitor. Subjects with long-term radiation-induced toxicity judged irreversible by the investigator may be included after consultation with the Medical Monitor.
- Administration of a live vaccine within 30 days prior to the first dose, or planned administration during the study.
- Known allergy to any component of any study drug; History of severe hypersensitivity reaction to other monoclonal antibodies.
- Known history of psychiatric disorder, drug abuse, alcoholism, or substance abuse.
- Pregnant or breastfeeding women.
- Any condition, therapy, laboratory abnormality, or other circumstance that might confound study results, interfere with the subject's participation for the full duration, or participation is not in the best interest of the subject.
- Local or systemic non-malignant disease, or tumor-associated conditions/symptoms that pose significant medical risk and/or uncertainty regarding survival evaluation, such as leukemoid reaction (WBC >20×10⁹/L), cachexia (e.g., known weight loss >10% in the 3 months prior to screening), etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan university cancer hospital
Shanghai
xin Liu, 021-64175590-88503, jeanettexin@hotmail.com
About this study
Official title: A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel, and Carboplatin as First- or Second-line Treatment for Patients With Advanced Acral and Mucosal Melanoma
This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab, in combination with bevacizumab, albumin-bound paclitaxel, and carboplatin as first- or second-line treatment in patients with acral and mucosal melanoma.
- Conditions
- Acral Melanoma, Mucosal Melanoma
- Being tested
- Iparomlimab and Tuvoraleimab injection+Bev+nab-PC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvoraleimab injection+Bev+nab-PCDrug
Iparomlimab and Tuvoraleimab injection: 5mg/kg, D1,Q3W; Bevacizumab: 7.5 mg/kg, D1, Q3W; Albumin-bound paclitaxel: 125mg/m2, D1,8, Q3W; Carboplatin: AUC=2, D1,8, Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bev+nab-PC | Experimental | Not described Receives: Drug: Iparomlimab and Tuvoraleimab injection+Bev+nab-PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Measured: up to 2 years
Secondary outcomes (6)
Disease control rate (DCR)
Defined as the percentage of participants in the analysis population who achieved Complete Response, Partial Response, or Stable Disease, as assessed by the investigator according to RECIST 1.1 criteria.
Measured: up to 2 years
Duration of Response (DoR)
Defined as the time from the first documented confirmed response (CR or PR) to the first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Measured: up to 2 years
Time to Response (TTR)
Defined as the time from the first administration of the investigational drug to the first occurrence of Complete Response (CR) or Partial Response (PR).
Measured: up to 2 years
Progression-Free Survival (PFS)
Defined as the time from the initiation of treatment until the first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Measured: up to 2 years
Overall Survival (OS)
Defined as the time from the initiation of treatment until death from any cause.
Measured: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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 posted16 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acral MelanomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347444
- Sponsor's protocol ID
- ITBAC
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel, and Carboplatin as First- or Second-line Treatment for Patients With Advanced Acral and Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT07347444
- Acronym / sponsor ID
- ITBAC
- Conditions
- Acral Melanoma, Mucosal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (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 is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab, in combination with bevacizumab, albumin-bound paclitaxel, and carboplatin as first- or second-line treatment in patients with acral and 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 |
|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bev+nab-PC | Experimental | Drug: Iparomlimab and Tuvoraleimab injection+Bev+nab-PC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects (or their legal representatives/guardians) must sign the informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures involved, and are willing to participate.
- Aged ≥18 years and ≤75 years, regardless of gender.
- Histologically or pathologically confirmed mucosal or acral melanoma.
- Braf, Nras, and Ckit gene mutation status is unrestricted.
- Unresectable or metastatic melanoma, having received ≤1 prior line of systemic therapy (disease recurrence or metastasis within 6 months after completion of adjuvant therapy is considered as first-line therapy).
Key exclusion criteria (29 listed)
- History or presence of other malignancies within the past 5 years, except for cured localized tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, etc.).
- Participation in treatment with an investigational drug or use of an investigational device within 4 weeks prior to the first dose of study treatment.
- Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks prior to the first dose; Treatment with Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose.
- Patients who have previously received iparomlimab and tuvoraleimab or other dual immunotherapy, bevacizumab, albumin-bound paclitaxel, or carboplatin.
- Active autoimmune disease that has required systemic treatment in the past two years (i.e., with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
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 |
|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bev+nab-PCIparomlimab and Tuvoraleimab injection: 5mg/kg, D1,Q3W; Bevacizumab: 7.5 mg/kg, D1, Q3W; Albumin-bound paclitaxel: 125mg/m2, D1,8, Q3W; Carboplatin: AUC=2, D1,8, Q3W. | Drug | Iparomlimab and Tuvoraleimab injection+Bev+nab-PC |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
6 secondary outcomes
Disease control rate (DCR)
Time frame: up to 2 years
Duration of Response (DoR)
Time frame: up to 2 years
Time to Response (TTR)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvoraleimab injection+Bev+nab-PC in people with Acral Melanoma and Mucosal Melanoma, run by Fudan University at 1 site 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 12 inclusion and 29 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: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xin Liu (021-64175590-88503, jeanettexin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 16 Jan 2026.