Study on Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for Treating Merkel Cell Carcinoma

Sponsor: Kartos Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03787602

Provider View

This clinical trial is testing a new oral medication, Navtemadlin (KRT-232), for patients with Merkel Cell Carcinoma (MCC) who have not responded to previous treatments or are new to certain immunotherapies. The study explores a new way to target the cancer by inhibiting a protein called MDM2.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a new oral drug, Navtemadlin (KRT-232), in treating Merkel Cell Carcinoma (MCC). This drug is being tested on patients who have not responded to at least one previous immunotherapy treatment or are new to these treatments. The study also looks at combining Navtemadlin with another drug, avelumab, for patients who have not yet received certain immunotherapies. The drug works by blocking a protein called MDM2, which is a new approach in treating MCC.

Eligibility Criteria

Inclusion Criteria

  • For some groups, patients must have tried and not responded to at least one PD-1 or PD-L1 inhibitor for advanced MCC.
  • For another group, patients must not have received any PD-1 or PD-L1 therapy before.
  • Some patients must not have had any previous chemotherapy.
  • Other patients must have had at least one previous chemotherapy treatment.
  • Must be in good overall health with a performance status score of 0 or 1.
  • Must have a confirmed diagnosis of MCC with at least one measurable tumor.
  • Cancer must express a specific protein called p53WT, confirmed by approved tests.
  • Must have adequate blood, liver, and kidney function.

Exclusion Criteria

  • For one group, patients must not have autoimmune diseases, need for systemic immunosuppression, previous stem cell transplant, or active hepatitis B or C infections.
  • Patients who have been treated with MDM2 or p53-targeted therapies before.
  • History of major organ transplant.
  • Patients with untreated cancer spread to the brain.
  • Patients with significant heart rhythm issues.

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