Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer

a study on Head and Neck Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Ezra Cohen, MD
Photo of Ezra Cohen
Ezra Cohen

Description

Summary

ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.

Official Title

A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer

Keywords

Metastatic Head and Neck Cancer Recurrent Head and Neck Cancer Head and Neck Neoplasms ADU-S100 ADU-S100 and pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histological or cytological confirmation of recurrent or metastatic HNSCC
  • Measurable disease as defined by RECIST v1.1
  • PD-L1 positive

You CAN'T join if...

  • Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma)
  • Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
  • Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of Arizona Cancer Center accepting new patients
    Tucson Arizona 85724 United States

Lead Scientist at UCSD

  • Ezra Cohen, MD
    Professor, Medicine. Authored (or co-authored) 188 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aduro Biotech, Inc.
ID
NCT03937141
Phase
Phase 2
Study Type
Interventional
Last Updated
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