Open

A phase II trial of induction and maintenance pembrolizumab and olaparib in locally advanced head and neck squamous cell carcinoma (HNSCC)

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

Age & Gender

18 years ~ 99 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team and discuss medications you are taking. The study also involves biopsies, blood draws, CT scans, and willingness to take the study medications regularly.

Incentives

You or your insurance provider will not have to pay for the olaparib and pembrolizumab while you take part in this study

In-person visits:
10 - 15

Total length of participation:
About One Year

Looking for Specific Volunteers

Able to participate:

you have been diagnosed with locally advanced head and neck squamous cell carcinoma
you are at least 18 years old on day of signing consent
you are willing to consent to a mandatory pre-study biopsy, unless sufficient archival tissue is available.
you haven't participated in a study of an investigational agent/device within 4 weeks prior to starting this study
you have no prior curative attempts for this cancer (i.e., surgery, radiation, systemic therapy)

Not eligible if:

You are Cisplatin-ineligible
You have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
You have severe, active medical comorbidity.
You are unable to swallow orally administered medication prior to initiation of study treatment
You had major surgery within 2 weeks of starting study treatment.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sid Sheth
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

22-0430

ClinicalTrials.gov

NCT05366166

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