Status:
RECRUITING
Pembrolizumab Plus Olaparib in LA-HNSCC
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Treatment outcomes are poor for patients with locally advance human papilloma virus (HPV) negative and high-risk HPV positive head and neck squamous cell carcinoma (HNSCC). One standard of care (SOC) ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
- 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
Exclusion
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05366166
Start Date
September 2 2022
End Date
October 31 2026
Last Update
April 23 2025
Active Locations (4)
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1
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
2
University of Louisville, Brown Cancer Center
Louisville, Kentucky, United States, 40202
3
UNC Lineberger
Chapel Hill, North Carolina, United States, 27514
4
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425