Pembrolizumab Plus Olaparib in LA-HNSCC

Running, not enrolling · Phase 2

Conditions studied: Squamous Cell Carcinoma of Head and Neck

In brief

The purpose of this research study is to evaluate the effectiveness of using a combination of pembrolizumab and olaparib when given before and after standard chemoradiation therapy in treating locally advanced head and neck squamous cell carcinoma. Pembrolizumab and olaparib are drugs that are approved for head and neck cancer treatment. However, FDA has not approved the use of these two drugs together in treating head and neck cancer.

Key facts

Study ID: NCT05366166
Run by: UNC Lineberger Comprehensive Cancer Center
People needed: 45
Starts: 2022-09-02
Expected to finish: 2030-11-21
Last updated by the study team: 2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Age >18 years on the day of signing the consent
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee. The subject must be willing to consent to a mandatory pre-study biopsy unless sufficient archival tissue is available.
Biopsy confirmed American Joint Committee on Cancer 8th Edition35 stage III-IV B oral cavity squamous cell carcinoma (SCC), p16-negative oropharyngeal SCC, stage III-IVB hypopharyngeal SCC, stage III-IVB laryngeal SCC -OR- HPV-associated oropharyngeal SCC (p16 positive or HPV-associated) T4 or N3 , T1-3 N2 or T3N0-1 with >10 pack-year tobacco history
At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by imaging (CT/ PET) and is suitable for repeated assessment.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
No prior curative attempts for this cancer (i.e., surgery, radiation, systemic therapy) and not currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of the study intervention. No evidence of metastatic disease (M0)

You may not qualify if…

Subjects with prior and concurrent malignancies of different tumor types whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drug are eligible with the following exception: Subjects with prior history of HNSCC treated < 3 years to the date of consent.
Cisplatin-ineligible as defined in the protocol.
Severe, active medical comorbidity. Subjects are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan or any psychiatric disorder that prohibits obtaining informed consent.
Subjects unable to swallow orally administered medication prior to initiation of study treatment.
Systemic glucocorticoids for any purpose other than to modulate symptoms from an event of clinical interest of suspected immunologic etiology

Where it is running

Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States
University of Louisville, Brown Cancer Center — Louisville, Kentucky, United States
UNC Lineberger — Chapel Hill, North Carolina, United States
Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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