Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD
Dates
study started
completion around
Principal Investigator
by Joel Baumgartner, MD (ucsd)Warren Chow, MD (uci)
Headshot of Joel Baumgartner
Joel Baumgartner

Description

Summary

The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

Official Title

An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients

Details

Keywords

Melanoma Stage IIIB/C, Melanoma, Daromun, Surgery, Adjuvant therapy

Eligibility

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UC Irvine Health-Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States

Lead Scientists at University of California Health

  • Joel Baumgartner, MD (ucsd)
    Joel M. Baumgartner, MD is a surgical oncologist with expertise in cancers of the GI tract and melanoma. He is board certified in general surgery and completed a surgical oncology fellowship at the University of Pittsburgh with a focus on clinical research, which included additional training in the development and conduct of clinical trials.
  • Warren Chow, MD (uci)
    Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 37 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Philogen S.p.A.
ID
NCT03567889
Phase
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
Expecting 186 study participants
Last Updated