Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
NCT ID: NCT03787602
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
115 participants
INTERVENTIONAL
2019-03-19
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1, Arm 1
KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 21-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Cohort 1, Arm 1b
KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 23-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Cohort 1, Arm 2b
KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Cohort 1, Arm 3
KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 21-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Cohort 1, Arm 5
KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Cohort 1 Expansion
KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Cohort 2, Arm 1 KRT-232 in combination with avelumab
KRT-232 will be administered orally, once daily (QD) on Days 1-5, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Avelumab
Avelumab is a PD-L1 blocking antibody anticancer drug administered by intravenous infusion.
Cohort 2, Arm 2 KRT-232 in combination with avelumab
KRT-232 will be administered orally, once daily (QD) on Days 1-7, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Avelumab
Avelumab is a PD-L1 blocking antibody anticancer drug administered by intravenous infusion.
Cohort 2 Expansion
KRT-232 will be administered orally, once daily (QD) per RP2D dose and schedule, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Avelumab
Avelumab is a PD-L1 blocking antibody anticancer drug administered by intravenous infusion.
Cohort 3
KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Cohort 4
KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Interventions
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KRT-232
KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
Avelumab
Avelumab is a PD-L1 blocking antibody anticancer drug administered by intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Miami Cancer Institute
Miami, Florida, United States
Moffitt
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Norton Healthcare
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson
Houston, Texas, United States
Inova Health Care Services
Fairfax, Virginia, United States
Princess Alexandra Hospital Oncology
Woolloongabba, , Australia
Centro Catarinense de Pesquisa (CECAP) - Hospital Santa Catarina de Blumenau
Blumenau, , Brazil
Instituto Nacional do Cancer
Brasília, , Brazil
Centro Intergado de Oncologia
Curitiba, , Brazil
Centro de Pesquisa Clinica em Oncologia
Ijuí, , Brazil
Clinica De Neoplasias Litoral
Itajaí, , Brazil
Hospital Paulistano
São Paulo, , Brazil
Princess Margaret Cancer Centre
Toronto, , Canada
CHU de Bordeaux- Hopital Saint-Andre
Bordeaux, , France
AP-HP Universite Paris Saclay
Gif-sur-Yvette, , France
CHU de Lille
Lille, , France
CHU Lyon-Sud
Lyon, , France
Hôpital de la Timone. Aix-Marseille Université
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
Hôpital Saint Louis - APHP
Paris, , France
CHU de Tours
Tours, , France
Vivantes Network for Health Gmb, Neukölln Clinic
Berlin, , Germany
Uniklinik Koln
Cologne, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen (AöR)
Essen, , Germany
Nationales Centrum für Tumorerkrankungen NCT
Heidelberg, , Germany
Universitätsklinik Rostock
Rostock, , Germany
Universitats-Hautklinik Tubingen
Tübingen, , Germany
Institute for Cancer Research and Treatment
Candiolo, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
AUSL della Romagna
Ravenna, , Italy
AOUS Le Scotte
Siena, , Italy
OSP Civile Maggiore Borgo Trento
Verona, , Italy
University Medical Center Groningen
Groningen, , Netherlands
National Cancer Center
Goyang-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital Duran i Reynals
Barcelona, , Spain
Hospital General Universitario Gregorio Marañn (Madrid)
Madrid, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Fundacio Investigao Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Norton Cancer Institute Research
Role: primary
Other Identifiers
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KRT-232-103
Identifier Type: -
Identifier Source: org_study_id
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