CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 45 target
Drug / intervention
Pembrolizumab +4 morebiological
Likely dose
Not stated in record
Key inclusion· 11
  • Pathologically confirmed persistent and/or locoregionally recurrent HNSCC
  • Oral cavity, pharynx, larynx, or unknown primary squamous cell carcinoma
  • Resectable disease as determined by surgeon and team
  • At least 18 years of age
Key exclusion· 15
  • Salivary gland carcinomas, lip carcinoma, adenocarcinoma of skin
  • Prior use of immune checkpoint blockade agent
  • History of HIV, hepatitis B or C
  • Unresectable disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04754321
NCT04754321Phase 1RecruitingOn TrackUpdated 4mo ago
Long Recruiting

HNSALV Trial: Combining Immunotherapy With Salvage Surgery and IORT for Treatment of Persistent/Recurrent Head and Neck Cancers

Ohio State University Comprehensive Cancer Center·interventional·Posted Feb 15, 2021·Updated Feb 2, 2026

In Brief

A Phase 1 clinical trial evaluating External Beam Radiation Therapy, Intraoperative Radiation Therapy, and 3 other interventions for Head and Neck Carcinoma of Unknown Primary and 5 related conditions. Currently recruiting, targeting 45 participants across 1 site.

Detailed Summary

This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). 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. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.

Study Details

Timeline

Phase 1Recruiting
2021202220232024202520262027
First PostedFeb 15, 2021
Enrollment StartMay 12, 2022
Primary CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 5.4 years agoPrimary completion in 6 months

Interventions

External Beam Radiation Therapyradiation

Undergo EBRT

Intraoperative Radiation Therapyradiation

Undergo IORT

Pembrolizumabbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Salvage Surgeryprocedure

Undergo salvage surgery