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Trial record 1 of 3 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Suspended, Terminated, Withdrawn, Unknown status Studies | ADU-S100
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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 : Terminated (No substantial anti-tumor activity was observed.)
First Posted : May 3, 2019
Results First Posted : January 3, 2022
Last Update Posted : January 3, 2022
Sponsor:
Information provided by (Responsible Party):
Chinook Therapeutics, Inc. ( Chinook Therapeutics, Inc. (formerly Aduro) )

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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
Actual Primary Completion Date : May 10, 2021
Actual Study Completion Date : June 10, 2021

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Arms and Interventions
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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


Outcome Measures
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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: 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.


Eligibility Criteria
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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
Contacts and Locations
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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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Sponsors and Collaborators
Chinook Therapeutics, Inc. (formerly Aduro)
  Study Documents (Full-Text)

Documents provided by Chinook Therapeutics, Inc. ( Chinook Therapeutics, Inc. (formerly Aduro) ):
Study Protocol  [PDF] January 19, 2021
Statistical Analysis Plan  [PDF] October 9, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chinook Therapeutics, Inc. (formerly Aduro)
ClinicalTrials.gov Identifier: NCT03937141    
Other Study ID Numbers: ADU-CL-20
First Posted: May 3, 2019    Key Record Dates
Results First Posted: January 3, 2022
Last Update Posted: January 3, 2022
Last Verified: December 2021

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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