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

AbbVie

Status and phase: Terminated; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: ABBV-368; Drug: ABBV-181; Drug: ABBV-927

Study type: Interventional

Funder types: Industry

Identifiers

NCT03818542

M19-228

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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3 participants in 4 patient groups

Arm 1: ABBV-181 IV

Experimental group

Description:

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

Treatment:

Drug: ABBV-181

Arm 2: ABBV-368 IV

Experimental group

Description:

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

Treatment:

Drug: ABBV-368

Arm 3: ABBV-927 IV

Experimental group

Description:

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

Treatment:

Drug: ABBV-927

Drug: ABBV-927

Arm 4: ABBV-927 IT

Experimental group

Description:

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

Treatment:

Drug: ABBV-927

Drug: ABBV-927