Recurrent Head and Neck Cancer Clinical Trial
Official title:
A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer
Verified date | December 2021 |
Source | Chinook Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | June 10, 2021 |
Est. primary completion date | May 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
United States | University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland |
United States | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama |
United States | MUSC Hollings Cancer Center | Charleston | South Carolina |
United States | Baylor University Medical Center | Dallas | Texas |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | UC San Diego Moores Cancer Center | La Jolla | California |
United States | James Graham Brown Cancer Center | Louisville | Kentucky |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Yale University Cancer Center | New Haven | Connecticut |
United States | University Pittsburgh Medical Center Hillman Cancer Center | Pittsburgh | Pennsylvania |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Regions Cancer Care Center | Saint Paul | Minnesota |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | University of Arizona Cancer Center | Tucson | Arizona |
United States | University of Kansas | Westwood | Kansas |
Lead Sponsor | Collaborator |
---|---|
Chinook Therapeutics, Inc. (formerly Aduro) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator. | Up to 25 months |
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