Unresectable/metastatic mucosal melanoma, cutaneous squamous cell carcinoma and appendageal carcinomas
Conditions
Interventions
medication administration:DNV3 injection and toripalimab combined chemotherapy
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures. 2.Age = 18 years. 3. Histologically confirmed unresectable/metastatic mucosal melanoma . 4. Previously untreated with any systemic therapy, including chemotherapyimmunotherapy, or targeted therapy (participants who have completed neoadjuvant or adjuvant therapy =6 months and experienced disease progression are eligible). 5. At least one measurable lesion via RECIST v1.1 criteria 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Expected survival = 3 months. 8. Adequate organ function .
Exclusion criteria
Exclusion criteria: 1. History of prior treatment with antibodies/drugs targeting the LAG-3 immune checkpoint. 2. Prior interruption of treatment due to severe and/or life-threatening adverse events related to anti-PD-1 or anti-PD-L1 antibody. 3. History of other malignancies within the past 5 years, with the exception of cured skin basal cell carcinoma, superficial bladder cancer, carcinoma in situ of the breast or cervical, papillary thyroid cancer. 4. Concurrent severe medical illnesses. 5. Active autoimmune disease or a history of autoimmune disease requiring systemic steroid therapy. 6. Active systemic infection requiring systemic treatment. 7. Known central nervous system metastases, or other central nervous system diseases or abnormalities, deemed unsuitable for inclusion in this study by the investigator. 8. Fertile individuals unable to maintain effective contraception during the trial. 9. Patients who are considered unsuitable for participating in this clinical trial due to other reasons by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR(objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR(disease control rate);PFS(Progression Free Survival);OS(Overall Survival);incidence of adverse events;Laboratory aberrations; | — |
Countries
china
Contacts
Public ContactChen Yu
Fujian Cancer Hospital
Outcome results
None listed