A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

Korábbi kezelés

• Prior radiotherapy
• Prior immunotherapy, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, and other systemic therapy for melanoma
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
• Prior allogeneic stem cell or solid organ transplantation
• Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
• Prior allogeneic stem cell or solid organ transplantation
• Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment

Más betegség

• History of in-transit metastases within the last 6 months
• Active or history of autoimmune disease or immune deficiency
• Active or history of autoimmune disease or immune deficiency
• Active or history of carcinomatous meningitis/leptomeningeal disease

Egyéb

• Mucosal, uveal and acral lentiginous melanoma
• Distantly metastasized melanoma
• Mucosal and uveal melanoma
• Symptomatic, untreated, or progressing CNS metastases
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Uncontrolled or symptomatic hypercalcemia

• ECOG performance status (PS) of 0 or 1
• Histologically confirmed resectable Stage III melanoma according to AJCC-8 and no history of in-transit metastases within the last 6 months
• Fit and planned for CLND
• Measurable disease according to RECIST v1.1
• Availability of a representative tumor specimen
• Adequate hematologic and end-organ function
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening. Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \>= 200/μL, and have an undetectable viral load.
• ECOG PS of 0 or 1
• Life expectancy \>= 3 months, as determined by the investigator
• Histologically confirmed Stage IV (metastatic) cutaneous melanoma according to AJCC-8
• Disease progression during or following at least one but no more than two lines of treatment for metastatic disease
• Measurable disease according to RECIST v1.1
• Availability of a representative tumor specimen
• Adequate hematologic and end-organ function
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening. Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \>= 200/μL, and have an undetectable viral load.