The goal of this clinical trial is provide new treatment for patients with advanced melanoma who have failed previous immunotherapy. The main questions it aims to answer are: * Efficacy of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma. * Safety of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma.
The study is divided into 5 phases: screening phase, washout phase, baseline phase, treatment phase and follow-up phase. Patients with advanced malignant melanoma who are eligible for screening and have failed previous anti-PD1 antibody therapy and who meet the inclusion exclusion criteria undergo elution with 1 PD1 monoclonal antibody injection, patients whose tumours progress after PD1 monoclonal antibody injection enter the treatment phase and are followed up every 1 month for at least 2 years in the follow-up phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
1. Recombinant Human Type 5 Adenovirus Injection: This is expected to be administered prior to immunotherapy, i.e. scheduled for injection at C1D1 (C2D1, C3D1, C4D1). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles. 2. PD1 monoclonal antibody (Tremelimumab): Administered intravenously within 48h of recombinant human adenovirus type 5 injection, scheduled at C1D2 (C2D2, C3D2, C4D2). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles.
Fujian Cancer Hospital, Department of Internal Medicine, Ward 19
Fuzhou, Fujian, China
Assessing the effectiveness of treatment through Objective Response Rate(ORR)
The proportion of CR and PR in all patients.
Time frame: 2 years
Assessing the effectiveness of treatment through Duration of Response(DOR)
This refers to the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first).
Time frame: 2 years
Assessing the effectiveness of treatment through Progression Free Survival(PFS)
Time from the date of first treatment to the first event of disease progression or death from any cause, whichever occurs first, with the endpoint event determined by the investigator in accordance with RECIST v1.1.
Time frame: 2 years
Assessing the effectiveness of treatment through Disease Control Rate(DCR)
Proportion of CR, PR and SD in all patients.
Time frame: 2 years
Assessing the effectiveness of treatment through Overall Survival(OS)
Time between the date of randomisation to the date of death from any cause or the end of the last follow-up visit.
Time frame: 2 years
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