Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
M19-228
- NCT ID:
NCT03818542
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ABBV-181 | | Arm 1: ABBV-181 IV |
ABBV-368 | | Arm 2: ABBV-368 IV |
ABBV-927 | | Arm 3: ABBV-927 IV |
ABBV-927 | | Arm 4: ABBV-927 IT |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1: ABBV-181 IV | Experimental | A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1. | |
Arm 2: ABBV-368 IV | Experimental | A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1. | |
Arm 3: ABBV-927 IV | Experimental | A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1. | |
Arm 4: ABBV-927 IT | Experimental | A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1. | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Changes in Gene Expression |
Time Frame: | Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration) |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | Maximum Serum Concentration (Cmax) of Study Drug |
Time Frame: | Up to approximately 120 days |
Safety Issue: | |
Description: | Maximum Serum Concentration (Cmax) of study drug |
Measure: | Time to Maximum Plasma Concentration (Tmax) of Study Drug |
Time Frame: | Up to approximately 120 days |
Safety Issue: | |
Description: | Time to Maximum Plasma Concentration (Tmax) of study drug |
Measure: | Area Under the Plasma Concentration-time Curve of Study Drug in Plasma |
Time Frame: | Up to approximately 120 days |
Safety Issue: | |
Description: | Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | AbbVie |
Trial Keywords
- Head and Neck Squamous Cell Carcinoma
- Cancer
- ABBV-927
- ABBV-368
- ABBV-181
- tumor resection
- immunotherapeutic drug
Last Updated
December 31, 2020