Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody

Official Title

A Phase II, Open Label Study to Investigate the Efficacy and Safety of Domatinostat in Combination With Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Antibody Therapy

Keywords

Merkel Cell Carcinoma Carcinoma, Merkel Cell Carcinoma domatinostat in combination with avelumab domatinostat and avelumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed Merkel Cell Carcinoma (MCC)
  • ECOG performance status ≤ 1
  • MCC in an advanced, unresectable stage III or metastatic stage IV (includes patients who refused surgical resection or are not eligible for such surgical resection)
  • Progressing on previous anti-PD-(L)1 antibody monotherapy within the last 12 weeks before planned first administration of study medication

You CAN'T join if...

  • History of serious anti-PD-(L)1 therapy-related adverse reactions prohibiting further avelumab treatment
  • More than one line of previous systemic anti-neoplastic therapy other than anti-PD-(L)1 antibody monotherapy
  • Palliative radiation therapy of single lesions within 2 weeks before planned administration of study medication
  • Presence of significant active or chronic disease (infections, immunodeficiencies, cardiovascular, psychiatric disorders)

Locations

  • UC Irvine Health, Chao Family Comprehensive Cancer Center not yet accepting patients
    Orange California 92868 United States
  • University of Washington - Seattle Cancer Care Alliance not yet accepting patients
    Seattle Washington 98109 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
4SC AG
ID
NCT04393753
Phase
Phase 2
Study Type
Interventional
Last Updated