Pembrolizumab plus targeted stereotactic radiotherapy for oligometastatic head and neck squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, multicenter phase III trial enrolling adults with PD-L1 CPS ≥1 and 1–5 oligometastatic head and neck squamous cell carcinomas. Participants are randomized 1:1 to receive pembrolizumab alone or pembrolizumab plus SABR directed to all metastatic lesions, after any definitive treatment to the primary site is completed. The primary outcome is progression-free survival, with treatments delivered per standard pembrolizumab schedules and SABR delivered to all lesions that are technically amenable. Eligibility requires measurable disease, staging within 12 weeks, and that all metastases be suitable for SABR.

Why it matters

Who can join: the full rules

Main inclusion Criteria:

* Male/female participants who are at least 18 years of age on the day of signing informed consent
* Histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or cervical primary occult and histologically or radiologically confirmed oligometastatic disease. Histological characterization of one metastatic lesion is strongly recommended.
* Patients with synchronous or metachronous oligometastatic disease according to the ESTRO/EORTC consensus (1-5 metastatic lesions, with or without primary/recurrent primary tumour and/or regional disease).
* Amenable to first-line systemic treatment for R/M SCCHN.
* For patients with oropharyngeal cancer: HPV status using p16 IHC evaluated locally.
* PD-L1 CPS of at least 1 as evaluated locally.
* Staging not older than 12 weeks before enrolment.
* All the 1-5 metastases must be amenable to SABR.
* Eligible for treatment with pembrolizumab.
* Have measurable disease based on RECIST 1.1.
* ECOG performance status of 0 to 1.
* Participants must have recovered from all treatment-related toxicities to baseline or grade ≤1, such as from previous radiotherapy, systemic treatment or surgery, and not requiring corticosteroids for managing treatment-related side effects.
* Adequate Organ Function Laboratory Values.
* Before patient registration/enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.

Main exclusion Criteria:

* Nasopharynx, sino-nasal, and salivary gland cancers are excluded.
* In-field progression in \< 6 months after curative intended locoregional irradiation of the head and neck.
* Lesions larger than 6 cm in the largest dimension as measured in the diagnostic CT or MRI scan for lesions outside the brain. Note: bone metastases over 6 cm may be included if in the opinion of the local radiation oncologist they can be treated safely and no inner organ is affected.
* Brain metastases only.
* Has received any previous radiotherapy to any of the 1-5 metastases that would be subject to SABR in the experimental arm unless the investigator agrees to treat only after discussion with the RTQA team.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
* Previously treated brain metastases that are radiologically non-stable. Patients with previously treated brain metastases, i.e., without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention, can participate.
* Known contraindication to imaging tracer or any product of contrast media and MRI contraindications.

Where it's running

• Cliniques Universitaires Saint-Luc
  Brussels, Belgium Recruiting
• AZ Groeninge Kortrijk - Campus Kennedylaan
  Kortrijk, Belgium Recruiting
• CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur
  Namur, Belgium Recruiting
• VITAZ St Niklaas - VITAZ- Oncology
  Sint-Niklaas, Belgium Recruiting
• Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA)
  Wilrijk, Belgium Recruiting
• Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
  Florence, Italy Recruiting

Study contacts

• Study coordinator: Eortc Hq
• Email: eortc@eortc.org
• Phone: +32 2 774 16 11

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Peripheral neuropathy during perioperative therapy with enfortumab vedotin and pembrolizumab in muscle-invasive urothelial cancer

  This study follows adults with muscle-invasive urothelial cancer to see how nerve-related side effects develop when people receive enfortumab vedotin and pembrolizumab around surgery as part of standard care.

  Recruiting at 3 sites Comprehensive Cancer Center Munich (CCCM) · Munich, Bavaria and 2 other locations · NCT07870577

• Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer

  This study tests whether the combination of Sacituzumab Tirumotecan and Pembrolizumab can help people with advanced biliary tract cancer who have already had at least one approved therapy fail.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07850791

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Ivonescimab plus enfortumab vedotin vs pembrolizumab plus enfortumab vedotin in untreated locally advanced or metastatic urothelial cancer

  This trial tests if adding ivonescimab to enfortumab vedotin works better than pembrolizumab plus enfortumab vedotin for people with untreated locally advanced or metastatic urothelial cancer.

  Recruiting at 2 sites Phase 2/3 Summit Therapeutics · Phoenix, Arizona and 6 other locations · NCT07815665

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.