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

Trial Status: Active

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.

Inclusion Criteria

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

Exclusion Criteria

  • 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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Lisle Marie Nabell
Phone: 205-934-3061

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: APPROVED
Emory University Hospital Midtown
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Tina M Livingood
Phone: 913-588-3671

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Aduro Biotech, Inc.

  • Primary ID ADU-CL-20
  • Secondary IDs NCI-2019-04759
  • Clinicaltrials.gov ID NCT03937141