Clinical trial NCT03818542: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: Head and Neck Squamous Cell Carcinoma
Cancer
ABBV-927
ABBV-368
ABBV-181
tumor resection
immunotherapeutic drug
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in Gene Expression
timeFrame: Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of Study Drug
timeFrame: Up to approximately 120 days
measure: Time to Maximum Plasma Concentration (Tmax) of Study Drug
timeFrame: Up to approximately 120 days
measure: Area Under the Plasma Concentration-time Curve of Study Drug in Plasma
timeFrame: Up to approximately 120 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 207392
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan /ID# 210181
state: Michigan
city: Houston
country: United States
facility: MD Anderson Cancer Center /ID# 208749
state: Texas
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: