In 2014, an estimated 7,000 patients were diagnosed of melanoma in China. It is growing at an annual rate of 3%-5% and approximately 20,000 new cases are reported each year recently.To date, CFDA only approved dacarbazine as first line chemotherapy and anti-PD-1 antibody monotherapy as second line. There is no standard of care after chemotherapy and anti-PD-1.
This is an open-label, randomized, single center phase 2 study evaluating the efficacy and safety of sitravatinib in combination with tislelizumab for Chinese patients with unresectable or metastatic melanoma after disease progression from prior anti-PD-1 antibody and chemotherapy. The first 20 patients will be randomized in a 1:1 ratio to receive either sitravatinib plus tislelizumab (Arm A) or sitravatinb monotherapy (Arm B). After the completion of initial 20 patients, additional patients will be recruited until 24 efficacy evaluable patients achieved in Arm A
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
sitravatinib 100mg QD PO
tislelizumab 200mg Q3W IV
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall response rate (ORR) in Arm A
defined as the proportion of participants with partial response or complete response as determined by the investigators based on RECIST v1.1
Time frame: 12 months
Overall response rate (ORR) in Arm B
defined as the proportion of participants with partial response or complete response as determined by the investigators based on RECIST v1.1
Time frame: 12 months
Disease control rate (DCR) in Arm A and B
defined as the proportion of participants whose best overall response (BOR) is complete response, partial response or stable disease as determined by investigators based on RECIST v1.1
Time frame: 12 months
Progression-free survival (PFS) in Arm A and B
defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
Time frame: 12 months
Incidence of Treatment-Emergent Adverse Events
According to National Cancer Institute Common Terminology Criteria for Adverse Events V5.0(CTCAE V5.0)
Time frame: 12 months
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