Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Me… (NCT04091217) | Clinical Trial Compass
CompletedPhase 2
Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
China43 participantsStarted 2019-11-25
Plain-language summary
This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab in patients with unresectable locally advanced or metastatic mucosal melanoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed unresectable locally advanced(stage III) or metastatic(Stage IV) mucosal melanoma
* May have received prior systemic treatment or treatment naive at enrollment
* Measurable disease per RECIST v1.1
* ECOG Performance Status of 0-1
* Life expectancy \>= 12 weeks
* Adequate hematologic and end-organ function
* Negative HIV test at screening
* Negative hepatitis B surface antigen test at screening
* Negative hepatitis B core antibody at screening, or positive total HBcAb test followed by quantitative hepatitis B virus DNA\<500 IU/mL at screening.
* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria:
* Symptomatic or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasth…
What they're measuring
1
Objective Response Rate (ORR) in the Full Analysis Set Analysis Population