Who is eligible for clinical trial NCT05366166?

Participants must meet the protocol's inclusion criteria for Squamous Cell Carcinoma of Head and Neck. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05366166 provide travel or cost reimbursement?

The protocol indicates compensation for participation. See the verified compensation note below. Confirm stipend details with the site coordinator.

🏛️ Verified NIH Record • Updated 2026-01-26

Pembrolizumab Plus Olaparib in LA-HNSCC (NCT05366166)

A Phase II Trial of Induction and Maintenance Pembrolizumab and Olaparib in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: UNC Lineberger Comprehensive Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (6 items).

Location: Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

Exclusion Criteria
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
💵 Compensation indicated: In the induction phase, participants will receive one infusion of pembrolizumab and will take olaparib tablets for a total of 21 days.

More studies in Squamous Cell Carcinoma of Head and Neck

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer — La Jolla, California
TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC — Tampa, Florida
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas — Philadelphia, Pennsylvania
5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC — New Haven, Connecticut
HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer — Dallas, Texas

Explore by condition: All Squamous Cell Carcinoma of Head and Neck clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗