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

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.

Study Overview

• Status: Terminated
• Conditions: Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer
• Intervention / Treatment: Drug: ADU-S100

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University Of Alabama Comprehensive Cancer Center
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University Cancer Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Greenebaum Comprehensive Cancer Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Cancer Care Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University Pittsburgh Medical Center Hillman Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Hollings Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADU-S100 and pembrolizumab; All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.	Drug: ADU-S100; intratumoral; Other Names: MIW815

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinook Therapeutics, Inc. (formerly Aduro)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: ADU-CL-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No