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NCT05366166 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab Plus Olaparib in LA-HNSCC
A Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 4
- Study locations
NCT05366166: Active Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05366166 is a Phase 2 study of Squamous Cell Carcinoma of Head and Neck that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 45 participants, below the 169-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (73% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05366166, a Phase 2 study of Squamous Cell Carcinoma of Head and Neck, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
One Year PFS will be defined as the period from the date of treatment start until disease progression or death (whichever occurs first) up to one year. Subjects who have not had an event will be censored at the date of last disease assessment documenting the subject was free of progression. Progression will be evaluated by RECIST v1.1 RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target les
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2030-11-21 |
| Phase | Phase 2 |
What the registry record for NCT05366166 still lists
NCT05366166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 169-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (73% lower).
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.
NCT05366166 reports a single indexed study location in Indiana, Kentucky, North Carolina.
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.
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).
Who is sponsoring clinical trial NCT05366166?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05366166's enrollment target sits among peer trials
45 25th of 37 higher than 13 of 37 other Squamous Cell Carcinoma of Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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