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.

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

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