Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel,… (NCT07347444) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
China48 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 withi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.