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Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC

NCT05433116 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-02

No results posted yet for this study

Summary

Open-label, two-arm, prospective multicenter phase II clinical trial to determine the efficacy and safety of combined pembrolizumab and lenvatinib compared to pembrolizumab alone as maintenance therapy after definitive radiochemotherapy of locally advanced head and neck squamous cell carcinoma (HNSCC).

Conditions

Interventions

DRUG

Pembrolizumab

i.v., 200mg absolute, q3w, starting within 14 days after completion of radiochemotherapy

DRUG

Lenvatinib

20mg once daily orally, start concomitant to cycle 2 of pembrolizumab

Sponsors & Collaborators

  • Universität des Saarlandes

    lead OTHER

Principal Investigators

  • Markus Hecht, Prof. · Saarland University Medical Center, Clinic for Radiotherapy and Radiooncology

  • Antoniu-Oreste Gostian, Prof. · University Hospital Straubing, Clinic for Otolaryngology, Head and Neck and Facial Plastic Surgery

  • Henning Kahl, MD · University Hospital Augsburg, Radiation Oncology

  • Rainer Fietkau, Prof. · University Hospital Erlangen, Radiation Oncology

  • Udo Gaipl, Prof. · University Hospital Erlangen, Radiation Oncology

  • Markus Eckstein, MD · University Hospital Erlangen, Pathology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT05433116 on ClinicalTrials.gov