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NCT03937141 Clinical Trial

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

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03937141
Other study ID # ADU-CL-20
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 26, 2019
Est. completion date June 10, 2021

Study information
Verified date December 2021
Source Chinook Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ADU-S100
intratumoral

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Chinook Therapeutics, Inc. (formerly Aduro)

Country where clinical trial is conducted

United States, 

Outcome
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
See also
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