Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Aug 12, 2025
  • participants needed
    115
  • sponsor
    Kartos Therapeutics, Inc.
Updated on 4 October 2022
platelet count
renal function
measurable disease
small molecule
pd-l1

Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy 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.

Details
Condition Merkel Cell Carcinoma
Treatment Avelumab, KRT-232
Clinical Study IdentifierNCT03787602
SponsorKartos Therapeutics, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
ECOG performance status of 0 to 1
Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST 1.1
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
Adequate hematological, hepatic, and renal functions
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)

Exclusion Criteria

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
Grade 2 or higher QTc prolongation (>480 milli-seconds per NCI-CTCAE criteria, version 5.0)
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
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