Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Merkel Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT03787602
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 115
- Starts
- 2019-03-19
- Expected to finish
- 2025-08-01
- Last updated by the study team
- 2023-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 qualify 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)
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
- Moffitt — Tampa, Florida, United States (enrolling)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
- Miami Cancer Institute — Miami, Florida, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (enrolling)
- Mount Sinai Hospital — New York, New York, United States (enrolling)
- Norton Healthcare — Louisville, Kentucky, United States (enrolling)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
- University of Texas MD Anderson — Houston, Texas, United States (enrolling)
- Inova Health Care Services — Fairfax, Virginia, United States (enrolling)
- Princess Alexandra Hospital Oncology — Woolloongabba, Australia (enrolling)
- Centro Catarinense de Pesquisa (CECAP) - Hospital Santa Catarina de Blumenau — Blumenau, Brazil (enrolling)
- Instituto Nacional do Cancer — Brasília, Brazil (enrolling)
- Centro Intergado de Oncologia — Curitiba, Brazil (enrolling)
- Centro de Pesquisa Clinica em Oncologia — Ijuí, Brazil (enrolling)
- Clinica De Neoplasias Litoral — Itajaí, Brazil (enrolling)
- Hospital Paulistano — São Paulo, Brazil (enrolling)
- Princess Margaret Cancer Centre — Toronto, Canada (enrolling)
- CHU de Bordeaux- Hopital Saint-Andre — Bordeaux, France (enrolling)
- AP-HP Universite Paris Saclay — Gif-sur-Yvette, France (enrolling)
- CHU de Lille — Lille, France (enrolling)
- CHU Lyon-Sud — Lyon, France (enrolling)
Full record on ClinicalTrials.gov
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