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Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC

NCT03426657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-11

No results posted yet for this study

Summary

First-line treatment of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration.

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

COMBINATION_PRODUCT

Durvalumab + Tremelimumab + RT

Patients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w).

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Rainer Fietkau, Prof. · Universitätsklinikum Erlangen, Strahlenklinik

  • Wilfried Budach, Prof. · University Düsseldorf

  • Claus Rödel, Prof. · Johann Wolfgang Goethe University Hospital

  • Markus Hecht, M.D. · Universitätsklinikum Erlangen

  • Udo Gaipl, Prof. · Universitätsklinikum Erlangen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2021-09-16
Completion
2024-02-29

Countries

  • Germany

Study Locations

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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 NCT03426657 on ClinicalTrials.gov