Phase
Condition
Malignant Melanoma
Melanoma
Treatment
N/AClinical Study ID
Ages 18-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All subjects must personally sign and date the consent form before initiating anystudy specific procedures or activities;
All subjects must be able to comply with all the scheduled procedures in the study;
HLA_A2 genotype and gp100 positive malignant melanoma: Ⅳ stage or relapsed aftersurgery or chemotherapy or no available standard therapy;
At least one measurable lesion per RECIST V1.1;
Aged 18 to 69 years;
Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performancestatus of≤2;
Systematic usage of immunosuppressive drug or corticosteroid must have been stoppedfor more than 4 weeks;
All other treatment induced adverse events must have been resolved to ≤grade 1;
Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L,Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN,Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);
Exclusion
Exclusion Criteria:
Presence of fungal, bacterial, viral, or other infection that is uncontrolled orrequiring iv antimicrobials for management. (Simple UTI and uncomplicated bacterialpharyngitis are permitted if responding to active treatment);
Patients with symptomatic central nervous system metastasis, intracranial metastasis,and cancer cells found in cerebrospinal fluid are not recommended to participate inthis study. Symptom free or post-treatment stable disease or disappearance of lesionsshould not be excluded. The specific selection is ultimately determined by theinvestigator;
Lactating women or women of childbearing age who plan to conceive during the timeperiod;
Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCVpositive);
Known history of infection with HIV;
Subjects need systematic usage of corticosteroid;
Subjects need systematic usage of immunosuppressive drug;
Planed operation, history of other related disease, or any other related laboratorytests restrict patients for the study;
Other reasons the investigator consider the patient may not be suitable for the study.
Study Design
Study Description
Connect with a study center
Hainan Cancer Hospital
Haikou, Hainan 570100
ChinaActive - Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan 570100
ChinaActive - Recruiting
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