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

NCT03818542 | Terminated Phase 1 FDA Drug

• 1 other identifier: M19-228
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Squamous Cell Carcinoma; Cancer; ABBV-927; ABBV-368; ABBV-181; tumor resection; immunotherapeutic drug

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum Serum Concentration (Cmax) of Study Drug

  Up to approximately 120 days

• 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

  Up to approximately 120 days

Study Arms (4)

Arm 1: ABBV-181 IV

EXPERIMENTAL

A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.

Drug: ABBV-181

Arm 2: ABBV-368 IV

EXPERIMENTAL

A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.

Drug: ABBV-368

Arm 3: ABBV-927 IV

EXPERIMENTAL

A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.

Drug: ABBV-927

Arm 4: ABBV-927 IT

EXPERIMENTAL

A single dose of ABBV-927 administered via intratumoral (IT) injection on Day 1.

Drug: ABBV-927

Interventions

ABBV-181 DRUG

intravenous infusion

Arm 1: ABBV-181 IV

ABBV-368 DRUG

intravenous infusion

Arm 2: ABBV-368 IV

ABBV-927 DRUG

intravenous infusion

Arm 3: ABBV-927 IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Massachusetts General Hospital /ID# 207392

Boston, Massachusetts, 02114, United States

Location

University of Michigan /ID# 210181

Ann Arbor, Michigan, 48109-5000, United States

Location

MD Anderson Cancer Center /ID# 208749

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasms

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: January 22, 2020
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)