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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937141
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Aduro Biotech, Inc.

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 Intervention/treatment Phase
Metastatic Head and Neck Cancer Recurrent Head and Neck Cancer Drug: ADU-S100 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: N/A
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 26, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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 Name: MIW815




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937141


Locations
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United States, Alabama
University of Alabama Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Erin D Finch, BSN, CCRP    205-975-0370    efinch@uab.edu   
Principal Investigator: Lisle M Nabell, MD         
United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Julie E Bauman, MD, MPH    520-626-4101    jebauman@email.arizona.edu   
Principal Investigator: Julie E Bauman, MD, MPH         
United States, Connecticut
Yale University Cancer Center Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Barbara Burtness, MD    203-373-6980    barbara.burtness@yale.edu   
Principal Investigator: Barbara Burtness, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Matthew Johnson    813-745-5434    matthew.johnson@moffitt.org   
Principal Investigator: Jameel Muzaffar, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Nabil F Saba, MD, FACP    404-778-3995    nfsaba@emory.edu   
Principal Investigator: Nabil F Saba, MD, FACP         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Susan Butcher    319-467-5827    susan-butcher@uiowa.edu   
Principal Investigator: Douglas Laux, MD         
United States, Kansas
University of Kansas Recruiting
Westwood, Kansas, United States, 66205
Contact: Prakash Neupane, MD    913-588-6029    pneupane@kumc.edu   
Principal Investigator: Prakash Neupane, MD         
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Rebecca Redman, MD    502-562-4673    ctobcc@louisville.edu   
Principal Investigator: Rebecca Redman, MD         
United States, Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Joann Alimurong    410-328-7904    joann.alimurong@umm.edu   
Principal Investigator: Ranee Mehra, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Leah Dunham    313-576-8496    DunhamL@karmanos.org   
Principal Investigator: Ammar Sukari, MD         
United States, Minnesota
Regions Cancer Care Center Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Lisa Wahowske, RN    651-254-1517    lisa.wahowske@parknicollet.com   
Principal Investigator: Arkadius Dudek, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Douglas Adkins, MD    314-747-8475    dadkins@wustl.edu   
Principal Investigator: Douglas Adkins, MD         
United States, Pennsylvania
University Pittsburgh Medical Center Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Brieana Marino    412-623-7039    rowlesbm@upmc.edu   
Principal Investigator: Dan P Zandberg, MD         
United States, South Carolina
MUSC Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brittanie Weinerman    843-792-6349    weinerma@musc.edu   
Principal Investigator: John Kaczmar, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Teresa Melton    615-936-7423    teresa.melton@vumc.org   
Principal Investigator: Michael K Gibson, MD         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Natasha Burks    214-818-2591    natasha.burk@bswhealth.org   
Principal Investigator: Eric Nadler, MD         
Sponsors and Collaborators
Aduro Biotech, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03937141    
Other Study ID Numbers: ADU-CL-20
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms