Melanoma (Skin Cancer)Early Phase 1NCT07586904
Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma.
A Early Phase 1 study testing Cadonilimab and Recombinant Human Interferon α1b Combination Therapy in people with Melanoma (Skin Cancer), run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Cadonilimab and Recombinant Human Interferon α1b Combination Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
- Serum total bilirubin ≤ 1.5 × ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)
- Prothrombin time (PT)/International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant used).
- 8.Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.
- 9.Female patients enrolled in the study must be willing to use appropriate contraception methods until 12 months after the last dose of the study drug.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital, Air Force Medical University Xi'an, Shaanxi, China
Xi'an
Weinan Guo, +862984775406, guown@fmmu.edu.cn
guown@fmmu.edu.cn
About this study
Official title: 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
- 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.
- 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).
- Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- Cadonilimab and Recombinant Human Interferon α1b Combination Therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab and Recombinant Human Interferon α1b Combination TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab and Recombinant Human Interferon α1b Combination Therapy Arm | Experimental | Not described Receives: Drug: Cadonilimab and Recombinant Human Interferon α1b Combination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure
Measured: through study completion, an average of 3 months
respiratory rate
respiratory rate
Measured: through study completion, an average of 3 months
body temperature
body temperature
Measured: through study completion, an average of 3 months
heart rate
heart rate
Measured: through study completion, an average of 3 months
Hemoglobin concentration
Hemoglobin concentration assessed by complete blood count
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Left ventricular ejection fraction (LVEF)
LVEF assessed by echocardiography
Measured: 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
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Platelet count
Platelet count assessed by complete blood count
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Alanine aminotransferase (ALT) level
ALT level measured from clinical biochemistry panel
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Aspartate aminotransferase (AST) level
AST level measured from clinical biochemistry panel
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Creatinine level
Creatinine level measured from clinical biochemistry panel
Measured: 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)
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Lactate dehydrogenase (LDH) level
LDH measured from clinical biochemistry panel
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Triiodothyronine (T3) level
T3 level measured from blood sample.
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Thyroid-stimulating hormone (TSH) level
TSH levell measured from blood sample.
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Left ventricular end-diastolic diameter (LVEDD)
LVEDD assessed by echocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
Cardiac output
Cardiac output estimated by echocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
PR interval
PR interval assessed by 12-lead electrocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
QRS duration
QRS duration assessed by 12-lead electrocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
Secondary outcomes (2)
Lymph node target lesion short-axis diameter
Short axis diameter of target lesions in lymph nodes, assessed by imaging (e. g., utrasonography, CT,or MRI per schedule of assessments
Measured: Baseline and every 3 weeks through study completion (up to 3 months）
Percentage of residual viable tumor cells in lymph nodes
Proportion of viable tumor cells in lymph node tissue assessed by histopathological analysis.
Measured: Perioperative (after 3 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 May 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586904
- Sponsor's protocol ID
- XJPF-LCY-V2025112
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07586904
- Acronym / sponsor ID
- XJPF-LCY-V2025112
- Conditions
- Melanoma (Skin Cancer)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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).
- Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab and Recombinant Human Interferon α1b Combination Therapy Arm | Experimental | Drug: Cadonilimab and Recombinant Human Interferon α1b Combination Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadonilimab and Recombinant Human Interferon α1b Combination TherapyCadonilimab: 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. | Drug | Cadonilimab and Recombinant Human Interferon α1b Combination Therapy Arm |
Primary outcome
Systolic blood pressure
Time frame: through study completion, an average of 3 months
Systolic blood pressure
respiratory rate
Time frame: through study completion, an average of 3 months
respiratory rate
body temperature
Time frame: through study completion, an average of 3 months
body temperature
heart rate
Time frame: through study completion, an average of 3 months
heart rate
Hemoglobin concentration
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
Hemoglobin concentration assessed by complete blood count
Left ventricular ejection fraction (LVEF)
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
LVEF assessed by echocardiography
White blood cell count
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
White blood cell count assessed by complete blood count
Platelet count
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
Platelet count assessed by complete blood count
Alanine aminotransferase (ALT) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
ALT level measured from clinical biochemistry panel
Aspartate aminotransferase (AST) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
AST level measured from clinical biochemistry panel
Creatinine level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
Creatinine level measured from clinical biochemistry panel
Blood glucose level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
Blood glucose level measured from clinical biochemistry panel (fasting or as specified in protocol)
Lactate dehydrogenase (LDH) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
LDH measured from clinical biochemistry panel
Triiodothyronine (T3) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
T3 level measured from blood sample.
Thyroid-stimulating hormone (TSH) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
TSH levell measured from blood sample.
Left ventricular end-diastolic diameter (LVEDD)
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
LVEDD assessed by echocardiography
Cardiac output
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
Cardiac output estimated by echocardiography
PR interval
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
PR interval assessed by 12-lead electrocardiography
QRS duration
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
QRS duration assessed by 12-lead electrocardiography
2 secondary outcomes
Lymph node target lesion short-axis diameter
Time frame: Baseline and every 3 weeks through study completion (up to 3 months）
Percentage of residual viable tumor cells in lymph nodes
Time frame: Perioperative (after 3 months of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cadonilimab and Recombinant Human Interferon α1b Combination Therapy in people with Melanoma (Skin Cancer), run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weinan Guo (+ 86-29-84775406, guown@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: through study completion, an average of 3 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.