Head and Neck Cancer
Conditions
Keywords
Head and Neck Squamous Cell Carcinoma, Cancer, ABBV-927, ABBV-368, ABBV-181, tumor resection, immunotherapeutic drug
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.
Interventions
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gene Expression | Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Serum Concentration (Cmax) of Study Drug | Up to approximately 120 days | Maximum Serum Concentration (Cmax) of study drug |
| Time to Maximum Plasma Concentration (Tmax) of Study Drug | Up to approximately 120 days | Time to Maximum Plasma Concentration (Tmax) of study drug |
| Area Under the Plasma Concentration-time Curve of Study Drug in Plasma | Up to approximately 120 days | Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma |
Countries
United States
Outcome results
None listed