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A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03818542
Recruitment Status : Terminated (Strategic considerations)
First Posted : January 28, 2019
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: ABBV-181 Drug: ABBV-368 Drug: ABBV-927 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Multi-Center Pharmacodynamic Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : January 22, 2020
Actual Primary Completion Date : September 23, 2020
Actual Study Completion Date : September 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: ABBV-181 IV
A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.
 Drug: ABBV-181
intravenous infusion
Experimental: Arm 2: ABBV-368 IV
A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.
 Drug: ABBV-368
intravenous infusion
Experimental: Arm 3: ABBV-927 IV
A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.
 Drug: ABBV-927
intravenous infusion
Experimental: Arm 4: ABBV-927 IT
A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.
 Drug: ABBV-927
intratumoral injection


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Gene Expression [ Time Frame: Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration) ]
    The primary biomarker endpoint is to assess immune activation gene changes in the tumor microenvironment associated with T cell infiltration and activation, comparing baseline biopsy to surgical resection following drug treatment.


Secondary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) of Study Drug [ Time Frame: Up to approximately 120 days ]
    Maximum Serum Concentration (Cmax) of study drug

  2. Time to Maximum Plasma Concentration (Tmax) of Study Drug [ Time Frame: Up to approximately 120 days ]
    Time to Maximum Plasma Concentration (Tmax) of study drug

  3. Area Under the Plasma Concentration-time Curve of Study Drug in Plasma [ Time Frame: Up to approximately 120 days ]
    Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Newly diagnosed stage 3 to 4B squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx who are candidates for surgical resection and are treatment-naïve. Participants must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist, and a radiation oncologist.
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 and life expectancy of more than 3 months.
  • Must consent to provide the tumor tissues for analyses as described in the protocol.
  • Must have adequate bone marrow function (without any growth factors or transfusions within 2 weeks prior to the first dose), kidney and liver function, with all laboratory values criteria detailed in the protocol.

Exclusion Criteria:

  • Has received live vaccine within 28 days prior to the first dose of study drug.
  • Has a history of inflammatory bowel disease, a history of or ongoing pneumonitis or interstitial lung disease, had major surgery ≤ 28 days prior to the first dose of study drug and the surgical wound is not fully healed.
  • Participants with hypopharyngeal or laryngeal tumors will not be candidates for Arm 4 of the study (IT injection of ABBV-927).
  • Requires use of an immunosuppressive medication within 14 days prior to the first dose of the study drug; exceptions are described in the protocol.
  • Has a confirmed positive test results for human immunodeficiency virus, or have active hepatitis A, B or C.
  • Has a history of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
  • Has a history of any other malignancy within the past 3 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ that is considered cured or adequately treated by the investigator.
Contacts and Locations
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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): NCT03818542


Locations
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United States, Massachusetts
Massachusetts General Hospital /ID# 207392
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan /ID# 210181
Ann Arbor, Michigan, United States, 48109-5000
United States, Texas
MD Anderson Cancer Center /ID# 208749
Houston, Texas, United States, 77030
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03818542    
Other Study ID Numbers: M19-228
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Head and Neck Squamous Cell Carcinoma
Cancer
ABBV-927
ABBV-368
 ABBV-181
tumor resection
immunotherapeutic drug
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site