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

Head and Neck Cancer Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT03818542
• Other study ID #: M19-228
• Status: Terminated
• Phase: Phase 1
• Start date: January 22, 2020
• Est. completion date: September 23, 2020

Study information

• Verified date: December 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• ABBV-181
intravenous infusion
• ABBV-368
intravenous infusion
• ABBV-927
intravenous infusion
• ABBV-927
intratumoral injection

Locations

Country	Name	City	State
United States	University of Michigan /ID# 210181	Ann Arbor	Michigan
United States	Massachusetts General Hospital /ID# 207392	Boston	Massachusetts
United States	MD Anderson Cancer Center /ID# 208749	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Serum Concentration (Cmax) of Study Drug	Maximum Serum Concentration (Cmax) of study drug	Up to approximately 120 days
Secondary	Time to Maximum Plasma Concentration (Tmax) of Study Drug	Time to Maximum Plasma Concentration (Tmax) of study drug	Up to approximately 120 days
Secondary	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