Who may be eligible for this recurrent head and neck cancer clinical trial?

Adults aged 18 years or older with locoregionally recurrent or second primary head and neck squamous cell carcinoma that cannot be surgically removed or where surgery may cause significant problems may be eligible. Patients must have PD-L1 positive tumors and no distant metastases. Please review eligibility criteria for more details.

Is there any cost to participate in this recurrent head and neck cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07026474

Randomized Phase III Trial of Sequential Re-Radiochemotherapy and Pembrolizumab Versus ImmunoChemoTherapy for Locoregionally Recurrent PD-L1 Positive HNSCC CPS1

Q: What is pembrolizumab studying for recurrent head and neck squamous cell carcinoma?

Pembrolizumab is being studied to see if combining it with re-radiochemotherapy improves survival for patients with locoregionally recurrent PD-L1 positive head and neck squamous cell carcinoma. This trial aims to compare this combination to pembrolizumab alone to find better treatment options.

Led by Universität des Saarlandes · Updated on 2026-03-02

214

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether combining re-radiochemotherapy Re-RCT with sequential immunotherapy using pembrolizumab improves overall survival compared to pembrolizumab alone, with or without chemotherapy, in patients with locoregionally recurrent PD-L1 positive head and neck squamous cell carcinoma HNSCC. This Phase III randomized controlled trial focuses on cases where the tumor is not surgically removable or surgery would cause significant problems, aiming to find better treatment options for these patients. Participants are assigned to one of two groups. One group receives re-radiochemotherapy with weekly cisplatin or carboplatin if kidney function is impaired followed by pembrolizumab immunotherapy for up to two years. The other group receives pembrolizumab alone for up to two years, with the option for additional chemotherapy cycles including cisplatin or carboplatin combined with 5-fluorouracil, based on the physicians decision. Radiotherapy doses range from 55.8Gy to 63.0Gy given in small weekly doses. During the study, participants undergo regular visits for treatment and evaluations including physical exams, laboratory tests, and monitoring of overall survival over two years. Researchers track treatment effects and safety, and participants must comply with scheduled visits and assessments. The study runs from October 2025 to December 2032, aiming to provide important information about treatment options for recurrent PD-L1 positive HNSCC.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Written informed consent obtained 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 HNSCC.
Tumor not surgically resectable or surgery carries high risk of functional problems or patient refuses surgery.
No distant metastases (cM0).
PD-L1 combined positive score (CPS) of 1 or higher confirmed by validated test.
Prior radiochemotherapy or radiotherapy to the neck at least 6 months before.
Adequate organ and marrow function as defined by specific blood counts and liver/kidney tests.
Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
Male participants must agree to use effective contraception.
Willing and able to comply with trial protocol and scheduled visits.

You will not qualify if you...

Prior radiochemotherapy or radiotherapy to the neck less than 6 months ago.
Presence of distant metastases (cM1).
Participation in another investigational trial or use of investigational agents within 4 weeks before treatment.
Use of immunosuppressive medication within 14 days before trial treatment, except certain low-dose or local steroids.
Recent chemotherapy or targeted therapy within defined timeframes before trial start.
History or current other malignancies unless disease-free for at least 3 years or certain skin cancers.
Active autoimmune disease requiring systemic treatment in past 2 years.
History or evidence of pneumonitis or interstitial lung disease.
Active infection requiring systemic antimicrobial therapy within 14 days before randomization.
Known hypersensitivity to study drugs or excipients.
Conditions or abnormalities that would interfere with trial participation or safety.
Psychiatric or substance abuse disorders affecting cooperation.
Pregnant or breastfeeding women, or those planning to conceive/father children during the trial period.
Infection with HIV, active hepatitis B or C.
Live vaccine within 30 days before planned trial therapy.
ECOG performance status greater than 2.
Prior treatment with PD-1/PD-L1 antibody in primary treatment less than 6 months ago.

Research Team

Studienzentrum der Klinik für Strahlentherapie und Radioonkologie

Markus Hecht, Prof. Dr. med.

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