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

Description

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.

Conditions

Merkel Cell Carcinoma

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Study Overview

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Study Details

Study overview

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.

A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients With p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed 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

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

Condition
Merkel Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Miami

Miami Cancer Institute, Miami, Florida, United States, 33176

Tampa

Moffitt, Tampa, Florida, United States, 33612

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60612

Louisville

Norton Healthcare, Louisville, Kentucky, United States, 40202

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215-5418

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

New York

Memorial Sloan-Kettering Cancer Center, New York, New York, United States, 10021

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kartos Therapeutics, Inc.,

Study Record Dates

2025-08