Status:
TERMINATED
A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
AbbVie
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 carcinom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03818542
Start Date
January 22 2020
End Date
September 23 2020
Last Update
December 31 2020
Active Locations (3)
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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