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Tests treatment safety and results for Melanoma (Skin Cancer)
Official title Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma.
ClinicalTrials.gov ID: NCT07586904
What this study is testing
What is Cadonilimab and Recombinant Human Interferon α1b Combination Therapy?
Cadonilimab and Recombinant Human Interferon α1b Combination Therapy is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for melanoma (skin cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Mucosal or ocular melanomas are excluded.
You likely can't join if
- The patient is currently participating, or has participated within 4 weeks prior to the first dose of the study drug, in another treatment clinical...
- The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (e.g...
- 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...
- The patient has a known history of hematologic malignancy, primary brain tumor, sarcoma, or another primary solid tumor, unless the patient has been...
- 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.
See the full eligibility criteria
- 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)
- 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...
- The patient is currently participating, or has participated within 4 weeks prior to the first dose of the study drug, in another treatment 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...
- 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...
- 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...
- Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of results, including active opportunistic or advanced (severe) infections; uncontrolled diabetes; cardiovascular...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.