Study Stopped
No substantial anti-tumor activity was observed.
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer
1 other identifier
interventional
16
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2019
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedStudy Start
First participant enrolled
August 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2021
CompletedResults Posted
Study results publicly available
January 3, 2022
CompletedJanuary 3, 2022
December 1, 2021
1.7 years
April 29, 2019
November 11, 2021
December 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
ADU-S100 and pembrolizumab
EXPERIMENTALAll eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
Interventions
Eligibility Criteria
You may qualify if:
- Histological or cytological confirmation of recurrent or metastatic HNSCC
- Measurable disease as defined by RECIST v1.1
- PD-L1 positive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Yale University Cancer Center
New Haven, Connecticut, 06520, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital
Atlanta, Georgia, 30308, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas
Westwood, Kansas, 66205, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Regions Cancer Care Center
Saint Paul, Minnesota, 55101, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Related Publications (1)
Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.
PMID: 32823563DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chinook Therapeutics, Inc. (formerly Aduro Biotech, Inc.)
- Organization
- Chinook Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 3, 2019
Study Start
August 26, 2019
Primary Completion
May 10, 2021
Study Completion
June 10, 2021
Last Updated
January 3, 2022
Results First Posted
January 3, 2022
Record last verified: 2021-12