RECRUITING

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

Conditions

Merkel Cell Carcinoma navtemadlin (KRT-232)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-03-19

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03787602

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

John Mei

CONTACT

650-542-0136

jmei@kartosthera.com

Emily Houlihan

CONTACT

401-954-8042

ehoulihan@kartosthera.com

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

Moffitt

Tampa, Florida, 33612

United States

Northwestern Memorial Hospital

Chicago, Illinois, 60612

United States

Norton Healthcare

Louisville, Kentucky, 40202

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215-5418

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2434

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

University of Texas MD Anderson

Houston, Texas, 77030

United States

Inova Health Care Services

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Kartos Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-19

Study Completion Date2025-08

Study Record Updates

Study Start Date2019-03-19

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

navtemadlin (KRT-232)

Additional Relevant MeSH Terms

Merkel Cell Carcinoma