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

NCT07586904 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Melanoma (Skin Cancer)

Interventions

DRUG

Cadonilimab 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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07586904 on ClinicalTrials.gov