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

NCT07586904 | Recruiting Early Phase 1

• 1 other identifier: XJPF-LCY-V2025112
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Primary Objective
2. 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. 3.Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.

Conditions

Melanoma (Skin Cancer)

Outcome Measures

Primary Outcomes (19)

• Systolic blood pressure

  Systolic blood pressure

  through study completion, an average of 3 months

• respiratory rate

  respiratory rate

  through study completion, an average of 3 months

• body temperature

  body temperature

  through study completion, an average of 3 months

• heart rate

  heart rate

  through study completion, an average of 3 months

• Hemoglobin concentration

  Hemoglobin concentration assessed by complete blood count

  Baseline and every 3 weeks through study completion (up to 3 months）

• Left ventricular ejection fraction (LVEF)

  LVEF assessed by echocardiography

  Baseline and every 8 weeks through study completion (up to 3 months)

• White blood cell count

  White blood cell count assessed by complete blood count

  Baseline and every 3 weeks through study completion (up to 3 months）

• Platelet count

  Platelet count assessed by complete blood count

  Baseline and every 3 weeks through study completion (up to 3 months）

• Alanine aminotransferase (ALT) level

  ALT level measured from clinical biochemistry panel

  Baseline and every 3 weeks through study completion (up to 3 months）

• Aspartate aminotransferase (AST) level

  AST level measured from clinical biochemistry panel

  Baseline and every 3 weeks through study completion (up to 3 months）

• Creatinine level

  Creatinine level measured from clinical biochemistry panel

  Baseline and every 3 weeks through study completion (up to 3 months）

• Blood glucose level

  Blood glucose level measured from clinical biochemistry panel (fasting or as specified in protocol)

  Baseline and every 3 weeks through study completion (up to 3 months）

• Lactate dehydrogenase (LDH) level

  LDH measured from clinical biochemistry panel

  Baseline and every 3 weeks through study completion (up to 3 months）

• Triiodothyronine (T3) level

  T3 level measured from blood sample.

  Baseline and every 3 weeks through study completion (up to 3 months）

• Thyroid-stimulating hormone (TSH) level

  TSH levell measured from blood sample.

  Baseline and every 3 weeks through study completion (up to 3 months）

• Left ventricular end-diastolic diameter (LVEDD)

  LVEDD assessed by echocardiography

  Baseline and every 8 weeks through study completion (up to 3 months)

• Cardiac output

  Cardiac output estimated by echocardiography

  Baseline and every 8 weeks through study completion (up to 3 months)

• PR interval

  PR interval assessed by 12-lead electrocardiography

  Baseline and every 8 weeks through study completion (up to 3 months)

• QRS duration

  QRS duration assessed by 12-lead electrocardiography

  Baseline and every 8 weeks through study completion (up to 3 months)

Secondary Outcomes (2)

• Lymph node target lesion short-axis diameter

  Baseline and every 3 weeks through study completion (up to 3 months）

• Percentage of residual viable tumor cells in lymph nodes

  Perioperative (after 3 months of treatment)

Study Arms (1)

Cadonilimab and Recombinant Human Interferon α1b Combination Therapy Arm

EXPERIMENTAL

Drug: Cadonilimab and Recombinant Human Interferon α1b Combination Therapy

Interventions

Cadonilimab and Recombinant Human Interferon α1b Combination Therapy DRUG

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.

Cadonilimab and Recombinant Human Interferon α1b Combination Therapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 surgically resected.
• Mucosal or ocular melanomas are excluded.
• Melanomas of unknown primary origin are excluded.
• Have not received treatment with PD-1, PD-L1, or PD-L2 antibodies, anti-CTLA4 antibodies, interferon (IFN), targeted therapy, radiotherapy, or systemic chemotherapy within the past month.
• Have an expected survival period of ≥ 6 months.
• Have at least one measurable lesion according to RECIST version 1.1.
• Have an ECOG performance status score of 0 or 1.
• Have adequate organ function, as indicated by the following laboratory values (within 4 weeks prior to the start of study treatment):
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
• Platelets ≥ 100 × 10⁹/L
• Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days prior to enrollment)
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN)

You may not qualify if:

• The patient is currently participating, or has participated within 4 weeks prior to the first dose of the study drug, in another interventional clinical trial of drugs or medical devices.
• The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.
• The patient has received systemic steroid therapy (\>10 mg/kg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive medication.
• The patient has a known history of hematologic malignancy, primary brain tumor, sarcoma, or another primary solid tumor, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• The patient has known central nervous system metastases and/or carcinomatous meningitis.
• The patient has a history of severe hypersensitivity to another monoclonal antibody (mAb) therapy.
• The patient has had an active autoimmune disease requiring systemic treatment (e.g., with corticosteroids or immunosuppressive drugs) within the past 2 years, and related replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency). Exceptions include patients with vitiligo, type I diabetes, childhood asthma/atopy.
• Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of results, including active opportunistic or advanced (severe) infections; uncontrolled diabetes; cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months); pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm); HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitative limit ≥500 IU/mL); or a documented history of tuberculosis.
• The patient has received a live vaccine within 4 weeks prior to the first dose; hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation; or major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.
• The patient has a known psychiatric or substance use disorder that would interfere with cooperation with trial requirements.
• The patient is pregnant or breastfeeding, or plans to become pregnant or father a child during the study period.
• Any other severe, acute, or chronic medical or laboratory abnormality that, in the investigator's judgment, could increase the risk associated with study participation or could interfere with the interpretation of study results.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

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

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Weinan Guo

CONTACT

+ 86-29-84775406; guown@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: May 14, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)