Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon
1. Primary Objective To evaluate the efficacy and safety of cadonilimab in combination with high-dose recombinant human interferon α1b injection as neoadjuvant therapy in patients with stage III/IV melanoma. Assessments include: Target lesion response (complete response \[CR\], partial response \[PR\], stable disease \
| Condition(s) | Melanoma (Skin Cancer) |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | 1. Primary Objective To evaluate the efficacy and safety of cadonilimab in combination with high-dose recombinant human interferon α1b injection as neoadjuvant therapy in patients with stage III/IV melanoma. Assessments include: Target lesion response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) Objective response rate (ORR) Pathological response rate (pathological complete response \[pCR\], near pCR, pathological partial response \[pPR\], pathological non-response \[pNR\]) Incidence of all adverse events (AEs) and serious adverse events (SAEs) Changes from baseline in physical examinations, vital signs, and laboratory test results. 2. Exploratory Objectives To investigate the correlation between treatment efficacy/patient outcomes |
| Who can participate | Inclusion Criteria: * Voluntarily participate in this trial, sign the informed consent form, and be between 18 and 75 years of age, regardless of gender. * Patients with histopathologically or cytologically confirmed stage III or resectable stage IV malignant melanoma. * Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis. * Resectable stage IV is defined as a single distant metastasis, excluding brain metastases or any other metastases that cannot be completely surgically resected. * Mucosal or ocular melanomas are excluded. * Melanomas of unknown primary origin are excluded. * Have not received treatment with PD-1, PD-L1, or PD-L2 antibodies, anti-CTLA4 antibodies, interferon (IFN), targeted therapy, radiotherapy, or s |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Xijing Hospital |
| Locations | Xi'an, China |
| Start date | 2025-05-01 |
| NCT ID | NCT07586904 |
| Official listing | https://clinicaltrials.gov/study/NCT07586904 |