Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
Purpose
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.
Conditions
- Metastatic Head and Neck Cancer
- Recurrent Head and Neck Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental ADU-S100 and pembrolizumab |
All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100. |
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More Details
- Status
- Terminated
- Sponsor
- Chinook Therapeutics, Inc. (formerly Aduro)