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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

Tracking Information
First Submitted Date  ICMJE January 24, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date December 31, 2020
Actual Study Start Date  ICMJE January 22, 2020
Actual Primary Completion Date September 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Maximum Serum Concentration (Cmax) of Study Drug [ Time Frame: Up to approximately 120 days ]
    Maximum Serum Concentration (Cmax) of study drug
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Drug: ABBV-181
    intravenous infusion
  • Drug: ABBV-368
    intravenous infusion
  • Drug: ABBV-927
    intravenous infusion
  • Drug: ABBV-927
    intratumoral injection
Study Arms  ICMJE
  • Experimental: Arm 1: ABBV-181 IV
    A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.
    Intervention: Drug: ABBV-181
  • Experimental: Arm 2: ABBV-368 IV
    A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.
    Intervention: Drug: ABBV-368
  • Experimental: Arm 3: ABBV-927 IV
    A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.
    Intervention: Drug: ABBV-927
  • Experimental: Arm 4: ABBV-927 IT
    A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.
    Intervention: Drug: ABBV-927
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 5, 2020)
3
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
52
Actual Study Completion Date  ICMJE September 23, 2020
Actual Primary Completion Date September 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03818542
Other Study ID Numbers  ICMJE M19-228
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP