Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT07586904

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

Led by Xijing Hospital · Updated on 2026-05-14

10

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Aged between 18 and 75 years, any gender
  • Diagnosed with stage III or resectable stage IV malignant melanoma confirmed by biopsy
  • Stage III includes at least one accessible lymph node metastasis or in-transit metastasis
  • Resectable stage IV means a single distant metastasis that can be fully removed by surgery, excluding brain metastases
  • No mucosal or ocular melanomas
  • No melanomas of unknown primary origin
  • No treatment with PD-1, PD-L1, PD-L2 antibodies, anti-CTLA4 antibodies, interferon, targeted therapy, radiotherapy, or systemic chemotherapy within the past month
  • Expected survival of at least 6 months
  • At least one measurable lesion by RECIST 1.1 criteria
  • ECOG performance status score of 0 or 1
  • Adequate organ function with lab values within specified limits in the 4 weeks before treatment
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days before first treatment
  • Female patients must agree to use contraception until 12 months after last treatment
Not Eligible

You will not qualify if you...

  • Participation in another drug or device clinical trial within 4 weeks before first dose
  • Anti-tumor therapy received within the past month, including chemotherapy, radiotherapy, immunotherapy
  • Systemic steroid or immunosuppressive therapy within 2 weeks before first dose
  • History of hematologic malignancy, primary brain tumor, sarcoma, or other primary solid tumors unless cured for 5 years
  • Known central nervous system metastases or carcinomatous meningitis
  • Severe allergy to monoclonal antibody therapy
  • Active autoimmune disease requiring systemic treatment within past 2 years except certain exceptions
  • Severe uncontrolled diseases including infections, uncontrolled diabetes, serious cardiovascular or pulmonary conditions, HIV, hepatitis B or C, or tuberculosis
  • Live vaccine within 4 weeks before first dose or major surgery within 2 weeks before treatment
  • Psychiatric or substance use disorder interfering with study compliance
  • Pregnancy, breastfeeding, or planning pregnancy during the study
  • Any other severe or acute medical or lab abnormalities that increase risk or interfere with study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

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

Xi'an, China

Actively Recruiting

Loading map...

Research Team

W

Weinan Guo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here