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

Sponsor

AbbVie (Industry)

Overall Status

Terminated

CT.gov ID

NCT03818542

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patient Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: ABBV-181 Drug: ABBV-368 Drug: ABBV-927 Drug: ABBV-927	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 22, 2020

Actual Primary Completion Date :

Sep 23, 2020

Actual Study Completion Date :

Sep 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: ABBV-181 IV A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.	Drug: ABBV-181 intravenous infusion
Experimental: Arm 2: ABBV-368 IV A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.	Drug: ABBV-368 intravenous infusion
Experimental: Arm 3: ABBV-927 IV A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.	Drug: ABBV-927 intravenous infusion
Experimental: Arm 4: ABBV-927 IT A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.	Drug: ABBV-927 intratumoral injection

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital /ID# 207392	Boston	Massachusetts	United States	02114
2	University of Michigan /ID# 210181	Ann Arbor	Michigan	United States	48109-5000
3	MD Anderson Cancer Center /ID# 208749	Houston	Texas	United States	77030