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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 With Recombinant Human Adenovirus Type 5 Injection | Experimental |
Dosage: 3mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Adenovirus Type 5 Injection | Drug |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the effectiveness of treatment through Objective Response Rate(ORR) | The proportion of CR and PR in all patients. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years |
| Assessing the effectiveness of treatment through Progression Free Survival(PFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the effectiveness of treatment through Quality of Life(QoL) | Evaluation based on ECOG scores | 2 years |
| Assessing security through Safety | Adverse events should be reported during the trial and the incidence of adverse events such as fever, nausea and vomiting, leukopenia, thrombocytopenia, alopecia, diarrhea, and immune-related adverse events due to T-cell activation should be monitored. Monitor for immune-related adverse events caused by T-cell activation, such as immune dermatitis, pneumonia, colitis, uveitis, arthritis, nephritis, etc. |
Inclusion Criteria:
18 years of age ≤ age ≤ 75 years of age, regardless of gender
have a pathological histological diagnosis of malignant melanoma
current physical condition and anticipated treatment plan judged by the investigator to be suitable for the treatment regimen of this trial;
a patient with malignant melanoma who has failed previous immunotherapy
at least one injectable lesion which must meet the RECIST 1.1 and iRECIST measurable target lesion requirements
the longest diameter of the injectable lesion must be ≥ 10 mm and ≤ 80 mm;
an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2;
laboratory tests must meet the following criteria:
have recovered from previous antineoplastic treatment to baseline or below grade 1 (CTCAE version 5.0) (except for alopecia and grade 2 anaemia) after an interval of ≥14 days between the date of first treatment and the date of the last previous antineoplastic treatment;
voluntarily signed informed consent with good expected compliance;
female patients of childbearing potential (including early menopause, menopause < 2 years and non-surgical sterilisation), male patients and partners of male patients must agree to use effective contraception during the study period: surgical sterilisation, oral contraceptive pills, intrauterine device, abstinence or barrier contraceptive method combined with spermicide; and contraception must be continued for 6 months after receiving the last, treatment.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital, Department of Internal Medicine, Ward 19 | Fuzhou | Fujian | China |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
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PD-1 With Recombinant Human Adenovirus Type 5 Injection
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|
|
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. |
| 2 years |
| Assessing the effectiveness of treatment through Disease Control Rate(DCR) | Proportion of CR, PR and SD in all patients. | 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. | 2 years |
| 2 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |