Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma.
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 adver
Trial Details
- NCT ID
- NCT07586904
- Phase
- EARLY_PHASE1
- Sponsor
- Xijing Hospital
- Status
- RECRUITING
- Cancer Type
- Melanoma
- Interventions
- Cadonilimab and Recombinant Human Interferon α1b Combination Therapy
- Locations (sample)
- Xi'an, China|34.25833,108.92861
Key Eligibility 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 surgica…
For full eligibility, visit ClinicalTrials.gov.
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