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

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: ABBV-181; Drug: ABBV-368; Drug: ABBV-927; Drug: ABBV-927

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 207392
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • University of Michigan /ID# 210181
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center /ID# 208749

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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; Drug: ABBV-927; intratumoral injection
Experimental: Arm 4: ABBV-927 IT; A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.	Drug: ABBV-927; intravenous infusion; Drug: ABBV-927; intratumoral injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gene Expression	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.	Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Serum Concentration (Cmax) of Study Drug	Maximum Serum Concentration (Cmax) of study drug	Up to approximately 120 days
Time to Maximum Plasma Concentration (Tmax) of Study Drug	Time to Maximum Plasma Concentration (Tmax) of study drug	Up to approximately 120 days
Area Under the Plasma Concentration-time Curve of Study Drug in Plasma	Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma	Up to approximately 120 days

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): September 23, 2020

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Head and Neck Squamous Cell Carcinoma; ABBV-181; tumor resection; ABBV-927; ABBV-368; immunotherapeutic drug
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: M19-228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No