About this trial
This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years and ≤ 75 years
Has a histologically confrmed diagnosis of malignant melanoma
Previously received failed first-line treatment for melanoma
Patients may have a history of liver metastases, but the metastases should be less than 3
Disqualifiers
Previous (within 5 years) or concurrent other malignant tumors, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer without recurrence > 3 years after radical resection
Has an active or potentially recurrent autoimmune disease
History of severe allergic reaction to any monoclonal antibody and/or component of the study drug
Known presence of active tuberculosis TB
Trial design
Single group
Treatments tested in this trial
Cadonilimab
DrugInjectable solution
anlotinib
Drugcapsule
Treatment groups
Trial outcomes
Primary outcomes
Response Rate
ORR is the proportion of patients with best response of complete response (CR) and PR
Secondary outcomes
Progression-free Survival (PFS)
Time from the date of frst study treatment administration to the date of first
Disease Control Rate (DCR)
Proportion of patients whose best overall response is either CR, PR, or SD
Safety and tolerability
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: