Melanoma
Conditions
Interventions
Advanced mucosal melanoma:Cadunilumab 10mg/kg every three weeks
The maximum duration of drug administration was 2 years until disease progression or death, intolerable toxicity, withdrawal at the initiative of the subject, or investigator's judgment that the subje
Advanced cutaneous melanoma:Cadunilumab 10mg/kg every three weeks
Advanced acral melanoma:Cadunilumab 10mg/kg every three weeks
renal cell carcinoma:Cadunilumab 10mg/kg every three weeks
Sponsors
the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Able to sign informed consent; 2) age =18 years old, =75 years old; 3) Cohort 1: histopathologically confirmed metastatic mucosal or acral or cutaneous advanced malignant melanoma who had received at least two lines of prior therapy, including but not limited to PD-1 or PD-L1 monoclonal antibody; Cohort 2: histopathologically confirmed metastatic renal cancer after at least a second line of previous therapy. 4) At least one imaging measurable lesion according to RECIST1.1 criteria; 5) ECOG physical performance score 0-2; 6) expected survival time =3 months; 7) Major organ function meets the following criteria 7 days before treatment: A. Blood routine: absolute neutrophil count =1.5×109/L; Hemoglobin =80g/L; Platelet count =90×109/L; B. Blood biochemistry: total bilirubin =1.5ULN; ALT and AST=2.5ULN (subjects with liver metastases were allowed ALT or AST=5×ULN); Serum creatinine =1.5ULN or creatinine clearance =50ml/min; C. Left ventricular ejection fraction =50%; D. Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =1.5ULN; E. Euthyroidism, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was outside the normal range, subjects could be included if the total T3 (or FT3) and FT4 were within the normal range F. Myocardial enzymes and troponin within the normal range (only laboratory abnormalities that were judged by the investigators to be clinically insignificant were allowed) 8) Women of childbearing age should consistently use effective contraceptive methods during the study and for 6 months after the study; A negative serum or urine pregnancy test within 7 days before study entry; Non-lactating patients; Men should agree to use effective contraception during the study period and for 6 months after the end of the study period; 9) patients were able to adhere to the study protocol.
Exclusion criteria
Exclusion criteria: 1) presence of symptomatic or untreated known brain or other central system metastases; Central nervous system metastases that had been completely resected and/or demonstrated to be stable or improving after radiotherapy were not an exclusion criterion, as long as they were stable on computed tomography (CT) for at least 4 weeks prior to screening, with no evidence of cerebral edema and no need for glucocorticoids or anticonvulsants; 2) uncontrolled active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.) at the time of screening; 3) Active hepatitis B or C: hepatitis B (defined as the presence of hepatitis B core antibody [HBcAb] or hepatitis B surface antigen [HBsAg], and hepatitis B virus DNA [HBV-DNA] > 1000cps/mL or > the lower limit of quantification according to local laboratory methods); Or hepatitis C (hepatitis C antibody and/or hepatitis C virus ribonucleic acid ([RNA]) test positive; 4) patients with HIV infection; 5) the patient is known to have systemic vasculitis (e.g., Wegener's granulomatosis, polyarteritis nodosa), systemic lupus erythematosus, or an active or uncontrolled autoimmune disorder (e.g., Crohns disease, rheumatoid arthritis, autoimmune hemolysis) Anemia, etc.), primary or secondary immunodeficiency (e.g., HIV infection or severe infectious diseases); 6) the patient had a known history of other malignant tumors; 7) those who are known to be allergic to the active ingredients or excipents of the study drug cadunilumab; 8) prior treatment with anti-CTLA-4-specific antibody drugs; 9) are currently participating in an interventional clinical study treatment or have received another study drug or investigational device within 4 weeks before the first dose; 10) received systemic treatment with anti-cancer Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose; 11) patients with high systemic use of glucocorticoids within 4 weeks before enrollment (inhaled corticosteroids were excluded); 12) severe mental disorders; 13) patients with severe heart, liver, kidney dysfunction, diabetes and other diseases; 14) pregnant or lactating women; 15) Any medical history or evidence of illness, abnormal treatment or laboratory values, or other conditions that might interfere with the results of the trial or prevent full participation in the study, or any other potential risk that might be considered by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Disease control rate;overall survival; | — |
Countries
China
Contacts
Public ContactYong Zhang
the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Outcome results
None listed