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ACTIVE NOT RECRUITING Phase 2

Pembrolizumab Plus Olaparib in LA-HNSCC

NCT05366166 · View on ClinicalTrials.gov ↗

Study 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 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.

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Cisplatin
  • DRUG Olaparib
  • RADIATION IMRT (intensity modulated radiation therapy)

Study Locations (4)

Indiana

  • Indiana University Simon Comprehensive Cancer Center — Indianapolis

Kentucky

  • University of Louisville, Brown Cancer Center — Louisville

North Carolina

  • UNC Lineberger — Chapel Hill

South Carolina

  • Medical University of South Carolina (MUSC) — Charleston

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2022-09-02
Est. Completion 2030-11-21
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05366166

The ClinicalTrials.gov registry entry for NCT05366166 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 374 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05366166 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Indiana, Kentucky, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05366166 about?

NCT05366166 is a clinical study titled "Pembrolizumab Plus Olaparib in LA-HNSCC". 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 appro...

What is the current status of trial NCT05366166?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2022-09-02. Estimated completion is 2030-11-21.

What conditions does trial NCT05366166 study?

This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05366166?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Olaparib (DRUG), IMRT (intensity modulated radiation therapy) (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05366166?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 374 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05366166 being conducted?

This trial has 4 study locations across Indiana, Kentucky, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial