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

NCT03787602 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-03-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Kartos Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2024-11-30
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787602 on ClinicalTrials.gov