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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

NCT ID: NCT03818542

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2020-09-23

Brief Summary

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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

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Conditions

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Head and Neck Cancer

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: ABBV-181 IV

A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.

Group Type EXPERIMENTAL

ABBV-181

Intervention Type DRUG

intravenous infusion

Arm 2: ABBV-368 IV

A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.

Group Type EXPERIMENTAL

ABBV-368

Intervention Type DRUG

intravenous infusion

Arm 3: ABBV-927 IV

A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.

Group Type EXPERIMENTAL

ABBV-927

Intervention Type DRUG

intravenous infusion

Arm 4: ABBV-927 IT

A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.

Group Type EXPERIMENTAL

ABBV-927

Intervention Type DRUG

intratumoral injection

Interventions

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ABBV-181

intravenous infusion

Intervention Type DRUG

ABBV-368

intravenous infusion

Intervention Type DRUG

ABBV-927

intravenous infusion

Intervention Type DRUG

ABBV-927

intratumoral injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Massachusetts General Hospital /ID# 207392

Boston, Massachusetts, United States

Site Status

University of Michigan /ID# 210181

Ann Arbor, Michigan, United States

Site Status

MD Anderson Cancer Center /ID# 208749

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M19-228

Identifier Type: -

Identifier Source: org_study_id