RecruitingEarly Phase 1NCT07586904

Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma.

Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma: A Single-Center, Open-Label, Phase Ib Trial


Sponsor

Xijing Hospital

Enrollment

10 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 and:PD-L1 expression in tumor tissue CD8+ T-cell infiltration Tumor mutational burden (TMB). 3. Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cadonilimab and Recombinant Human Interferon α1b Combination Therapy for people with melanoma (skin cancer). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab and Recombinant Human Interferon α1b Combination Therapy

Cadonilimab: 10 mg/kg administered via intravenous infusion every 3 weeks. The neoadjuvant treatment course consists of 4 cycles, totaling 3 months. Recombinant Human Interferon α1b Injection: 600 μg administered subcutaneously every other day. The neoadjuvant treatment course is 3 months. If intolerable (e.g., occurrence of Grade 3 or 4 adverse reactions or other qualifying events), the dose should be reduced to 300 μg subcutaneously every other day.


Locations(1)

Xijing Hospital, Air Force Medical University Xi'an, Shaanxi, China

Xi'an, China

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NCT07586904


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