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Radiotherapy With Pembrolizumab in Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT03386357 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-03-27

Study results available
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Summary

Randomized phase II study of immune stimulation with Pembrolizumab and radiotherapy in second line therapy of metastatic head and neck squamous cell carcinoma.

Conditions

Interventions

COMBINATION_PRODUCT

A (pembrolizumab+RT)

Pembrolizumab (200mg absolute, q3w) combined with radiotherapy (12x3Gy) of one, two or three metastases. Only metastases that perspectively require radiotherapy will be treated. The irradiated tumor volume must be at least 10cm³. Radiotherapy of brain metastases is not allowed.

DRUG

B (pembrolizumab)

Pembrolizumab (200mg absolute, q3w)

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Rainer Fietkau, Prof. · Universitätsklinikum Erlangen, Strahlenklinik

  • Wilfried Budach, Prof. · University Düsseldorf

  • Markus Hecht, M.D. · Universitätsklinikum Erlangen

  • Hausmann Jan, M.D. · University Düsseldorf

  • Udo Gaipl, Prof. · Universitätsklinikum Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-20
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386357 on ClinicalTrials.gov