Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04340258 · ClinicalTrials.gov registry record · Phase 1

Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC

A Phase 1 study of HNSCC, sponsored by University of Cincinnati.

Active
Registry status
Phase 1
Development phase
50
Enrollment target
2
Study locations

NCT04340258: Active Phase 1 study of HNSCC, sponsored by University of Cincinnati.

NCT04340258 is a Phase 1 study of HNSCC that is active but no longer recruiting, run by University of Cincinnati. The registered enrollment target is 50 participants, below the 188-participant average among 23 other HNSCC trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04340258, a Phase 1 study of HNSCC, is active but no longer recruiting, sponsored by University of Cincinnati.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
2
Study locations

Study Summary

To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.

Primary Outcome

Phase Ib: To determine the safety of the combination of pembrolizumab and Cesium-131 in recurrent HNSCC patients undergoing salvage surgical resection. A 3+3 safety run in will be conducted for the phase 1b part of the protocol. Safety monitoring will begin at the time of enrollment on the study and will continue for at least 4 weeks after completion of the last treatment dose on study.

Conditions Studied

HNSCC

Interventions

  • DRUG Pembrolizumab
  • DEVICE Cesium-131

Study Locations (2)

Ohio

  • University of Cincinnati Medical Center - Cincinnati

Pennsylvania

  • Thomas Jefferson - Philadelphia

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-02-04
Est. Completion 2025-09-04
Phase Phase 1
University of Cincinnati

245 total trials

What the registry record for NCT04340258 still lists

NCT04340258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 188-participant average among 23 other HNSCC trials with a reported enrollment target (73% lower).

The record links to 1 condition, with HNSCC appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT04340258 reports a single indexed study location in Ohio, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04340258 about?

NCT04340258 is a clinical study titled "Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC". To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.

What is the current status of trial NCT04340258?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2021-02-04. Estimated completion is 2025-09-04.

What conditions does trial NCT04340258 study?

This clinical trial studies the following conditions: HNSCC.

What interventions are being tested in trial NCT04340258?

The interventions under investigation include: Pembrolizumab (DRUG), Cesium-131 (DEVICE).

Who is sponsoring clinical trial NCT04340258?

This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04340258 being conducted?

This trial has 2 study locations across Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HNSCC

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04340258's enrollment target sits among peer trials

50 14th of 23 higher than 9 of 23 other HNSCC trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HNSCC 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00200889 · 50 participants · Early Phase 1

    Mapping Auricular Vagus Nerve Circuitry

  • NCT00409435 · 50 participants · Phase 2

    A Study of Pyridostigmine in Postural Tachycardia Syndrome

  • NCT01202305 · 50 participants

    The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

  • NCT01225913 · 50 participants · Phase 4

    Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT04340258, the US trial registry maintained by the National Library of Medicine. NCT04340258 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.