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Pembrolizumab for Head and Neck Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Head and Neck Squamous Cell CarcinomaPembrolizumab - Drug
Eligibility
19 - 90
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the safety and efficacy of combining PD-1 inhibitor and Cesium-131 interstitial brachytherapy in patients with head and neck squamous cell carcinoma.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 4 years

2 years
Disease-free survival
Overall Safety measured by dose limiting toxicities (DLTs).
4 years
Adverse events
Loco-regional control rate
Overall Survival

Trial Safety

Safety Progress

1 of 3

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1
Bapotulimab (BAY1905254) + Pembrolizumab
2
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Pembrolizumab

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

Pembrolizumab & Cesium-131
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2

Pembrolizumab & Cesium-131Experimental Group · 2 Interventions: Cesium-131, Pembrolizumab · Intervention Types: Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

University of CincinnatiLead Sponsor
388 Previous Clinical Trials
635,585 Total Patients Enrolled
IsoRay Medical, Inc.Industry Sponsor
3 Previous Clinical Trials
Shuchi Gulati, MDPrincipal Investigator - University of Cincinnati
University of Cincinnati Medical Center
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 19 - 90 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have locally recurrent head and neck squamous cell carcinoma and are eligible for salvage surgery.
If patient received radiation therapy in the past, they should have recovered from the acute toxicity to <grade 1.
The tumor needs to be considered resectable.
References

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