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

NCT07347444 | Not Yet Recruiting Phase 2

• 1 other identifier: ITBAC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acral Melanoma; Mucosal Melanoma

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 years

Secondary Outcomes (6)

• Disease control rate (DCR)

  up to 2 years

• Duration of Response (DoR)

  up to 2 years

• Time to Response (TTR)

  up to 2 years

• Progression-Free Survival (PFS)

  up to 2 years

• Overall Survival (OS)

  up to 2 years

Study Arms (1)

Iparomlimab and Tuvoraleimab injection+Bev+nab-PC

EXPERIMENTAL

Drug: Iparomlimab and Tuvoraleimab injection+Bev+nab-PC

Interventions

Iparomlimab and Tuvoraleimab injection+Bev+nab-PC DRUG

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.

Iparomlimab and Tuvoraleimab injection+Bev+nab-PC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university cancer hospital

Shanghai, China

Location

Central Study Contacts

xin Liu

CONTACT

021-64175590-88503; jeanettexin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)