RecruitingPhase 3NCT07026474

Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC

Randomized Phase III Trial of Sequential Re-Radiochemotherapy and Pembrolizumab Versus Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive HNSCC (CPS≥1)

Sponsor

Universität des Saarlandes

Enrollment

214 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma

Summary

Prospective, open-label, randomized controlled phase III trail that aims to investigate whether Re-Radiochemotherapy (Re-RCT) and sequential immunotherapy with pembrolizumab improves overall survival compared to the standard treatment with pembrolizumab alone (± chemotherapy) in locoregionally recurrent PD-L1 positive (CPS≥1) HNSCC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing re-irradiation (radiation given again to the same area) plus chemotherapy and pembrolizumab (an immunotherapy) versus immunotherapy alone for people with head and neck cancer that has come back in the same region after prior radiation treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has come back locally after prior radiation - Your cancer cannot be safely removed with surgery, or surgery would cause significant functional harm - Your cancer has not spread to distant organs - Your tumor tests positive for PD-L1 (CPS score of 1 or higher) - At least 6 months have passed since your prior radiation treatment - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your cancer has spread to distant sites (metastatic) - Your PD-L1 test is negative - You have not completed at least 6 months since prior neck radiation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERradiotherapy

single doses of 1.8Gy up to a total dose of 55.8Gy to 63.0Gy

DRUGCisplatin

40mg/m² BSA weekly concomitant to re-irradiation

DRUGPembrolizumab

i.v., 200mg absolute, q3w

DRUGcisplatin + 5-fluorouracil (5FU)

Cisplatin: 100mg/m² BSA d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w

DRUGAlternative medications: carboplatin + 5-fluorouracil (5FU)

Carboplatin: AUC5 d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w

DRUGAlternative medications: carboplatin

AUC2 weekly

DRUGPembrolizumab

i.v., 200mg absolute, q3w, starting within 8-14 days after completion of RCT

Locations(18)

Klinikum Chemnitz gGmbH, Klinik für Radioonkologie

Chemnitz, Germany

Klinikum Darmstadt GmbH, Institut für Radioonkologie und Strahlentherapie

Darmstadt, Germany

Gemeinschaftspraxis Hämatologie-Onkologie Dresden

Dresden, Germany

Uniklinikum Erlangen, Strahlenklinik

Erlangen, Germany

Universitätsmedizin Frankfurt, Klinik für Strahlentherapie und Onkologie

Frankfurt am Main, Germany

UKGM Gießen, Klinik für Strahlentherapie

Giessen, Germany

Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie; II. Medizinische Klinik und Poliklinik

Hamburg, Germany

Medizinische Hochschule Hannover (MHH), Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation

Hanover, Germany

Marien Hospital Herne, Klinik für Strahlentherapie und Radio-Onkologie

Herne, Germany

Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie

Homburg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Radioonkologie der Strahlentherapie

Mainz, Germany

Universitätsklinikum Münster, Klinik für Strahlentherapie - Radioonkologie

Münster, Germany

Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

Regensburg, Germany

CaritasKlinikum Saarbrücken St. Theresia, Klinik für Radioonkologie und Strahlentherapie

Saarbrücken, Germany

Klinikum St.-Elisabeth Straubing GmbH, Klinik für Hals-Nasen-Ohren-Heilkunde

Straubing, Germany

Klinikum Stuttgart, Klinik für Strahlentherapie und Radioonkologie

Stuttgart, Germany

Universitätsklinikum Tübingen, Klinik für Radioonkologie

Tübingen, Germany

Universitätsklinikum Ulm, Klinik für Hals- Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

Ulm, Germany

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NCT07026474

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