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

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ClinicalTrials.gov Identifier: NCT03937141
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : September 26, 2019
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
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

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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, 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 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, 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, 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, Pennsylvania
University Pittsburgh Medical Center Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Brienana Marino    412-623-7039    rowlesbm@upmc.edu   
Principal Investigator: Dan P Zandberg, MD         
Sponsors and Collaborators
Aduro Biotech, Inc.

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Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03937141     History of Changes
Other Study ID Numbers: ADU-CL-20
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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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
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents