This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • Clinicaltrials.gov identifier

    NCT03937141

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 3, 2019

  • Last update posted

    March 10, 2021

Study Description

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.

  • Condition or Disease:Metastatic Head and Neck Cancer
    Recurrent Head and Neck Cancer
  • Intervention/Treatment: Drug: ADU-S100
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 16 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2022

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 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 [ Time Frame: 25 months ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Locations

United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham

United States, Arizona
University of Arizona Cancer Center
Tucson

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

United States, Connecticut
Yale University Cancer Center
New Haven

United States, Florida
Moffitt Cancer Center
Tampa

United States, Georgia
Emory University Hospital
Atlanta

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City

United States, Kansas
University of Kansas
Westwood

United States, Kentucky
James Graham Brown Cancer Center
Louisville

United States, Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore

United States, Michigan
Karmanos Cancer Institute
Detroit

United States, Minnesota
Regions Cancer Care Center
Saint Paul

United States, Missouri
Washington University School of Medicine
Saint Louis

United States, Pennsylvania
University Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh

United States, South Carolina
MUSC Hollings Cancer Center
Charleston

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville

United States, Texas
Baylor University Medical Center
Dallas

Sponsors and Collaborators

Chinook Therapeutics, Inc.

More Information