For Cohort 1, 3 and 4 patients must have failed treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for metastatic MCC
For Cohort 2, patients must not have received any anti-PD-1 or anti-PD-L1 therapy
For Cohort 3, patients must not have received any prior chemotherapy
For Cohort 4, patients must have received at least one prior line of chemotherapy
ECOG performance status of 0 to 1
Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST 1.1
MCC expressing p53WT based on any CLIA or test approved by local health authority or a validated test (Cohort 1 and 2)
MCC expressing p53WT based Central Lab test (Cohort 3 and 4)
Adequate hematological, hepatic, and renal functions
You may not be if
For Cohort 2, subjects must not have autoimmune disease, medical conditions requiring systemic immunosuppression, prior stem cell transplant, or active infection with HBV or HCV.
Patients previously treated with MDM2 antagonist therapies or p53-directed therapies
History of major organ transplant
Patients with known central nervous system (CNS) metastases that are previously untreated
Grade 2 or higher QTc prolongation (\>480 milli-seconds per NCI-CTCAE criteria, version 5.0)
Clareo Health | Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
