Actively Recruiting
Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC
Led by Universität des Saarlandes · Updated on 2026-03-02
214
Participants Needed
18
Research Sites
374 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent provided prior to any study procedures
- Age 18 years or older at study entry
- ECOG performance status of 0, 1, or 2
- Locoregionally recurrent or second primary head and neck squamous cell carcinoma
- Histological confirmation of head and neck squamous cell carcinoma
- Tumor not suitable for surgery or surgery would cause significant functional problems, or patient refuses surgery
- No distant metastases (cM0)
- PD-L1 combined positive score of 1 or higher confirmed by a validated test in an accredited lab
- Prior radiochemotherapy of the neck at least 6 months before
- Adequate organ and bone marrow function: hemoglobin ≥ 9.0 g/dL; leukocytes ≥ 3,000/mm3 or neutrophils ≥ 1,500/mm3; platelets > 100,000/mm3
- Serum bilirubin ≤ 1.5 times upper normal limit (except Gilbert's syndrome)
- AST/ALT ≤ 2.5 times upper limit of normal
- Creatinine clearance ≥ 40 ml/min (calculated)
- Women of childbearing potential must have a negative pregnancy test within 72 hours before first treatment and agree to use effective contraception during the trial and for 120 days after last treatment
- Men must agree to use effective contraception during the trial and for 120 days after last treatment
- Willing and able to comply with protocol including treatment and scheduled visits
You will not qualify if you...
- Prior radiochemotherapy to the neck less than 6 months ago
- Presence of distant metastases (cM1)
- Currently participating in another trial or received investigational therapy within 4 weeks before first dose
- Use of immunosuppressive medication within 14 days before first dose (exceptions apply)
- Prior chemotherapy or targeted therapy within 2 weeks or monoclonal antibody within 4 weeks before trial day 1, unless neuropathy grade ≤ 2
- History or current other malignancy unless disease-free for at least 3 years or certain skin cancers treated
- Active autoimmune disease requiring systemic treatment within past 2 years
- History of pneumonitis requiring steroids or evidence of interstitial lung disease
- Active or chronic infection requiring systemic therapy within 14 days before randomization
- Known allergy to study drugs or excipients
- Conditions or abnormalities interfering with participation or trial results
- Psychiatric or substance abuse disorders interfering with trial requirements
- Pregnant or breastfeeding, or planning pregnancy during trial and 120 days after last dose
- HIV infection
- Active hepatitis B or C infection
- Live vaccine within 30 days before planned treatment start
- ECOG performance status greater than 2
- Prior PD-1/PD-L1 antibody treatment for locally advanced HNSCC less than 6 months ago
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Klinikum Chemnitz gGmbH, Klinik für Radioonkologie
Chemnitz, Germany, 09116
Actively Recruiting
2
Klinikum Darmstadt GmbH, Institut für Radioonkologie und Strahlentherapie
Darmstadt, Germany, 64283
Actively Recruiting
3
Gemeinschaftspraxis Hämatologie-Onkologie Dresden
Dresden, Germany, 01307
Actively Recruiting
4
Uniklinikum Erlangen, Strahlenklinik
Erlangen, Germany, 91054
Actively Recruiting
5
Universitätsmedizin Frankfurt, Klinik für Strahlentherapie und Onkologie
Frankfurt am Main, Germany, 60590
Actively Recruiting
6
UKGM Gießen, Klinik für Strahlentherapie
Giessen, Germany, 35392
Actively Recruiting
7
Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie; II. Medizinische Klinik und Poliklinik
Hamburg, Germany, 20246
Not Yet Recruiting
8
Medizinische Hochschule Hannover (MHH), Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Hanover, Germany, 30625
Not Yet Recruiting
9
Marien Hospital Herne, Klinik für Strahlentherapie und Radio-Onkologie
Herne, Germany, 44625
Actively Recruiting
10
Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie
Homburg, Germany, 66421
Actively Recruiting
11
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Radioonkologie der Strahlentherapie
Mainz, Germany, 55131
Actively Recruiting
12
Universitätsklinikum Münster, Klinik für Strahlentherapie - Radioonkologie
Münster, Germany, 48149
Not Yet Recruiting
13
Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie
Regensburg, Germany, 93053
Actively Recruiting
14
CaritasKlinikum Saarbrücken St. Theresia, Klinik für Radioonkologie und Strahlentherapie
Saarbrücken, Germany, 66113
Not Yet Recruiting
15
Klinikum St.-Elisabeth Straubing GmbH, Klinik für Hals-Nasen-Ohren-Heilkunde
Straubing, Germany, 94315
Not Yet Recruiting
16
Klinikum Stuttgart, Klinik für Strahlentherapie und Radioonkologie
Stuttgart, Germany, 70174
Actively Recruiting
17
Universitätsklinikum Tübingen, Klinik für Radioonkologie
Tübingen, Germany, 72076
Actively Recruiting
18
Universitätsklinikum Ulm, Klinik für Hals- Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
Ulm, Germany, 89075
Actively Recruiting
Research Team
S
Studienzentrum der Klinik für Strahlentherapie und Radioonkologie
CONTACT
M
Markus Hecht, Prof. Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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