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NCT04862455 · ClinicalTrials.gov registry record · Phase 2
NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT04862455: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT04862455 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04862455, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This phase II trial investigates the effect of NBTXR3, radiation therapy, and pembrolizumab in treating patients with head and neck squamous cancer that has come back (recurrent) or has spread to other places in the body (metastatic). NBTXR3 may cause cell destruction when activated by radiation. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. And hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, and pembrolizumab may kill more tumor cells.
Primary Outcome
Will be estimated using the method of Kaplan-Meier. Median times and 95% the determination of best objective response.
Interventions
- BIOLOGICAL Pembrolizumab
- RADIATION Stereotactic Body Radiation Therapy
- RADIATION Hypofractionated Radiation Therapy
- OTHER Hafnium Oxide-containing Nanoparticles NBTXR3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-04-07 |
| Est. Completion | 2026-01-21 |
| Phase | Phase 2 |
Why NCT04862455 stopped before completion
NCT04862455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04862455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04862455 about?
NCT04862455 is a clinical study titled "NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer". This phase II trial investigates the effect of NBTXR3, radiation therapy, and pembrolizumab in treating patients with head and neck squamous cancer that has come back (recurrent) or has spread to other places in the body (metastatic). NBTXR3 may cause cell destruction when activated by radiation. Ra...
What is the current status of trial NCT04862455?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2021-04-07. Estimated completion is 2026-01-21.
What interventions are being tested in trial NCT04862455?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Stereotactic Body Radiation Therapy (RADIATION), Hypofractionated Radiation Therapy (RADIATION), Hafnium Oxide-containing Nanoparticles NBTXR3 (OTHER).
Who is sponsoring clinical trial NCT04862455?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04862455's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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