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NCT05526924 · ClinicalTrials.gov registry record · Phase 1
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05526924: Recruiting Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Chicago.
NCT05526924 is a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 30 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05526924, a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety, tolerability and maximum tolerated dose of tislelizumab in combination with pamiparib plus chemoradiotherapy (chemotherapy and radiation) in individuals with recurrent head and neck cancer, which means that the person's cancer has come back after treatment. Participation in the study should last for about 15 months while participants receive tislelizumab and chemoradiotherapy with pamiparib. Afterwards, they will return to the clinic for follow up every 4 months for 2 years, every 6 month for the next 2 years, and then once a year for the rest of their life.
Primary Outcome
Determine the maximally tolerated dose (MTD)/ recommended phase 2 dose (RP2D) for pamiparib in combination with FHX and tislelizumab in subjects with recurrent head and neck squamous cell carcinoma (HNSCC) as assessed by the incidence of dose-limiting toxicities (side effects) reported among study participants. Dose-limiting toxicities will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Conditions Studied
Interventions
- RADIATION Chemoradiation
- DRUG Pamiparib
- DRUG Hydroxyurea
- DRUG Fluorouracil (5FU)
- DRUG Tislelizumab
Study Locations (1)
Illinois
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-03-07 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
What NCT05526924 shows while recruiting
NCT05526924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which Chemoradiation is the first listed.
NCT05526924 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05526924 about?
NCT05526924 is a clinical study titled "Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer". The purpose of this study is to evaluate the safety, tolerability and maximum tolerated dose of tislelizumab in combination with pamiparib plus chemoradiotherapy (chemotherapy and radiation) in individuals with recurrent head and neck cancer, which means that the person's cancer has come back after ...
What is the current status of trial NCT05526924?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-03-07. Estimated completion is 2028-01-01.
What conditions does trial NCT05526924 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma, Head and Neck Cancer Stage IV, Head and Neck Cancers - Throat.
What interventions are being tested in trial NCT05526924?
The interventions under investigation include: Chemoradiation (RADIATION), Pamiparib (DRUG), Hydroxyurea (DRUG), Fluorouracil (5FU) (DRUG), Tislelizumab (DRUG).
Who is sponsoring clinical trial NCT05526924?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05526924 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05526924's enrollment target sits among peer trials
30 174th of 250 higher than 66 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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