NCT03787602

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Kartos Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
DRUG	KRT-232	KRT-232 is an experimental MDM2 anticancer drug taken by mouth.
DRUG	Avelumab	Avelumab is a PD-L1 blocking antibody anticancer drug administered by intravenous infusion.

Timeline

• Start date: 2019-03-19
• Primary completion: 2024-11-01
• Completion: 2025-08-01
• First posted: 2018-12-26
• Last updated: 2023-03-02

Locations

51 sites across 10 countries: United States, Australia, Brazil, Canada, France, Germany, Italy, Netherlands, South Korea, Spain

Regulatory

• FDA-regulated drug study