Brief Summary
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinomacancer arising from tissues that line organs (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapya treatment that uses a person's immune system to fight cancer or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC.
Intervention / Treatment
- Drug: KRT-232
- Drug: Avelumab
Inclusion Criteria:
- 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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells
- 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