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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Head/Neck
Phase II
Adults
Mol. targeted/Immunotherapy/Biologics
ADU-S100, MK-3475, Pembrolizumab (MK-3475)
Gibson, Mike
National
Vanderbilt University
03-03-2020
Treatment
VICCHN1976
NCT03937141

Eligibility

18 Years
BOTH
NO
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

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