This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab in patients with unresectable locally advanced or metastatic mucosal melanoma.
The study is divided into 2 stages. Stage I of the study is completed when 22 patients with measurable disease have been enrolled and completed ORR evaluation. If the number of responders in Stage I is more than 3, another 16 patients may be enrolled to Stage II.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Atezolizumab 1200 mg will be administered intravenously every 3 weeks.
Bevacizumab 7.5 mg/kg will be administered intravenously every 3 weeks.
Beijing Cancer Center; Renal Cancer And Melanoma Department.
Beijing, China
Fujian Provincial Cancer Hospital
Fuzhou, China
Zhejiang Cancer Hospital
Zhejiang, China
Objective Response Rate (ORR) in the Full Analysis Set Analysis Population
ORR was defined as the percentage of participants with a complete response (CR) defined as disappearance of all target lesions, or partial response (PR) defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR, on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time frame: Up to approximately 32 months
Progression-Free Survival (PFS)
PFS was defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time frame: Up to approximately 32 months
Overall Survival (OS)
Overall survival was defined as the time from the date of first treatment to death from any cause.
Time frame: Up to approximately 32 months
Duration of Objective Response (DOR)
DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: Up to approximately 32 months
Disease Control Rate (DCR)
DCR was defined as the sum of a complete or partial response or stable disease rates as determined by the investigator according to RECIST v1.1.
Time frame: Up to approximately 32 months
Percentage of Participants With Adverse Events
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The percentage of participants who experienced an Adverse Event (AE) or Serious Adverse Event (SAE). Incidence, nature, and severity of Adverse Events (AE), are reported per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
Time frame: From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)