Actively Recruiting
Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon 1b in Stage III/IV Melanoma: A Single-Center, Open-Label, Phase Ib Trial
Led by Xijing Hospital · Updated on 2026-05-14
10
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of cadonilimab combined with high-dose recombinant human interferon 1b as a pre-surgery treatment for patients with stage III or resectable stage IV melanoma. The study focuses on tumor response, including complete and partial responses, and pathological analysis of tumor samples, while monitoring side effects and changes in physical exams and lab tests. The trial also explores how tumor markers like PD-L1, CD8+ T cells, and tumor mutation burden relate to treatment outcomes to support future larger studies. Participants receive cadonilimab through an intravenous infusion at a dose of 10 mg/kg every three weeks, for a total of four cycles over three months. Alongside, recombinant human interferon 1b is given by subcutaneous injection at 600 bcg every other day for three months, with dose adjustments if side effects occur. This open-label, early-phase trial is conducted at a single center, focusing on this combined neoadjuvant therapy approach. During the study, participants undergo regular monitoring including vital signs like blood pressure, heart rate, respiratory rate, and body temperature, as well as detailed laboratory tests such as blood counts, liver and kidney function, and heart function assessments. Imaging and pathological evaluations of lymph nodes are performed to assess tumor response. These evaluations occur at baseline and at scheduled intervals throughout the three-month treatment period, ensuring close safety surveillance and effectiveness measurement.
CONDITIONS
Brief Title
Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years, any gender
- Have histopathologically or cytologically confirmed stage III or resectable stage IV malignant melanoma
- Stage III includes at least one clinically accessible lymph node metastasis or in-transit metastasis
- Resectable stage IV defined as single distant metastasis excluding brain metastases and unresectable 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
- Presence of at least one measurable lesion per RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate organ function as shown by recent lab tests meeting specified thresholds
- Female participants of childbearing potential must have a negative pregnancy test before first dose
- Female participants must agree to use contraception until 12 months after last dose
You will not qualify if you...
- Participation in another interventional clinical trial within 4 weeks prior to dosing
- Receipt of any anti-tumor therapy within the past month
- Use of systemic steroids over 10 mg/kg prednisone or immunosuppressive drugs within 2 weeks prior to dosing
- History of hematologic malignancy, primary brain tumor, sarcoma, or other primary solid tumor unless cured with no recurrence for 5 years
- Presence of central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to monoclonal antibody therapy
- Active autoimmune disease requiring systemic treatment within past 2 years, except vitiligo, type I diabetes, or childhood asthma
- Severe uncontrolled diseases including active infections, uncontrolled diabetes, cardiovascular or pulmonary diseases, HIV, hepatitis, or tuberculosis
- Receipt of live vaccine within 4 weeks prior, hematopoietic growth factors within 2 weeks, or major surgery within 2 weeks prior to treatment
- Known psychiatric or substance use disorders interfering with trial compliance
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Any other severe medical or lab abnormalities increasing risk or interfering with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive neoadjuvant treatment with Cadonilimab administered via intravenous infusion every 3 weeks for 4 cycles, combined with subcutaneous injections of Recombinant Human Interferon α1b every other day for 3 months.
4 visits every 3 weeks (in-person) for Cadonilimab infusions; subcutaneous injections every other day for Interferon
Trial Site Locations
Total: 1 location
1
Xijing Hospital, Air Force Medical University Xi'an, Shaanxi, China
Xi'an, China
Actively Recruiting
Research Team
W
Weinan Guo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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