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

Phase 2

Terminated

• Conditions: Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer
• Interventions: Drug: ADU-S100

• Registration Number: NCT03937141
• Lead Sponsor: Chinook Therapeutics, Inc. (formerly Aduro)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-08-26
• Primary Completion: 2021-05-10
• Study Completion: 2021-06-10
• Results First Submitted: 2021-11-11
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-03
• Last Update Submitted: 2021-12-03
• Results First Posted: 2022-01-03
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADU-S100 and pembrolizumab	ADU-S100	All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.

Primary Outcome Measures

Name	Time	Method
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	Up to 25 months	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.

Trial Locations

Locations (17)

University of Kansas; 🇺🇸 Westwood, Kansas, United States

University of Maryland, Greenebaum Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Yale University Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Regions Cancer Care Center; 🇺🇸 Saint Paul, Minnesota, United States

University Pittsburgh Medical Center Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

MUSC Hollings Cancer Center; 🇺🇸 Charleston, South Carolina, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States