Clinical Trials /

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

NCT03818542

Description:

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.

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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: 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

Clinical Trial IDs

  • ORG STUDY ID: M19-228
  • NCT ID: NCT03818542

Conditions

  • Head and Neck Cancer

Interventions

DrugSynonymsArms
ABBV-181Arm 1: ABBV-181 IV
ABBV-368Arm 2: ABBV-368 IV
ABBV-927Arm 3: ABBV-927 IV
ABBV-927Arm 4: ABBV-927 IT

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm 1: ABBV-181 IVExperimentalA single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.
  • ABBV-181
Arm 2: ABBV-368 IVExperimentalA single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.
  • ABBV-368
Arm 3: ABBV-927 IVExperimentalA single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.
  • ABBV-927
Arm 4: ABBV-927 ITExperimentalA single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.
  • ABBV-927

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Changes in Gene Expression
Time Frame:Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)
Safety Issue:
Description: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

Measure:Maximum Serum Concentration (Cmax) of Study Drug
Time Frame:Up to approximately 120 days
Safety Issue:
Description:Maximum Serum Concentration (Cmax) of study drug
Measure:Time to Maximum Plasma Concentration (Tmax) of Study Drug
Time Frame:Up to approximately 120 days
Safety Issue:
Description:Time to Maximum Plasma Concentration (Tmax) of study drug
Measure:Area Under the Plasma Concentration-time Curve of Study Drug in Plasma
Time Frame:Up to approximately 120 days
Safety Issue:
Description:Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Head and Neck Squamous Cell Carcinoma
  • Cancer
  • ABBV-927
  • ABBV-368
  • ABBV-181
  • tumor resection
  • immunotherapeutic drug

Last Updated

October 30, 2019