Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
completion around
Principal Investigator
by Deborah J. Wong, MD, PhD (ucla)
Headshot of Deborah J. Wong
Deborah J. Wong

Description

Summary

Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.

Official Title

An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Details

Keywords

HNSCC, Squamous Cell Carcinoma of Head and Neck, Pembrolizumab, Danvatirsen, Danvatirsen plus pembrolizumab

Eligibility

Locations

  • University of California Irvine (UCI) accepting new patients
    Irvine California 92617 United States
  • University of California Los Angeles accepting new patients
    Westwood California 90024 United States
  • TMPN Hunt Cancer Care accepting new patients
    Torrance California 90505 United States

Lead Scientist at University of California Health

  • Deborah J. Wong, MD, PhD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Flamingo Therapeutics NV
ID
NCT05814666
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 81 study participants
Last Updated