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

Stopped early · Phase 1

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT03818542

Run by

AbbVie

People needed

3

Starts

2020-01-22

Expected to finish

2020-09-23

Last updated by the study team

2020-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital /ID# 207392 — Boston, Massachusetts, United States
• University of Michigan /ID# 210181 — Ann Arbor, Michigan, United States
• MD Anderson Cancer Center /ID# 208749 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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