Actively Recruiting
Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-05-05
200
Participants Needed
30
Research Sites
253 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
S
Swiss Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized open-label multicentre phase III superiority study of the effect of adding SABR to the standard of care treatment pembrolizumab on progression free survival in patients with oligometastases of a squamous cell carcinoma of the head and neck (SCCHN), histological confirmation of the primary disease at first diagnosis, and PD-L1 CPS ≥1. After eligibility check and signing informed consent, all patients will be prospectively enrolled in a 1:1 ratio between current standard of care treatment (pembrolizumab, Arm 1) vs. SABR + standard of care treatment (Arm 2) to oligometastases. Any radical treatment to the synchronous primary/ recurrent primary tumor and/or involved cervical nodes (surgery or radiotherapy), as decided by the local tumor board/ treating physicians, should be completed prior to enrolment.Surgical removal of metastases is allowed for diagnostic purposes or for brain metastases, as long as these metastases count toward the total number of 5 and at least one metastasis is left for treatment with SABR. Such surgical procedures should be performed prior to enrolment.
CONDITIONS
Official Title
Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at consent
- Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx, or cervical primary occult) with confirmed oligometastatic disease
- 1 to 5 metastatic lesions according to ESTRO/EORTC criteria, with or without primary or regional disease
- Eligible for first-line systemic treatment for recurrent/metastatic SCCHN
- For oropharyngeal cancer patients, HPV status evaluated locally by p16 IHC
- PD-L1 combined positive score (CPS) of at least 1
- Staging performed within 12 weeks before enrollment
- All metastases must be suitable for SABR treatment
- Eligible for pembrolizumab treatment
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Recovery to baseline or grade 1 from previous treatment toxicities, without need for corticosteroids
- Adequate organ function based on laboratory tests
- Written informed consent given according to regulations before enrollment
You will not qualify if you...
- Nasopharynx, sino-nasal, and salivary gland cancers
- Progression within 6 months after curative head and neck radiotherapy in the treated field
- Lesions larger than 6 cm outside the brain (bone metastases over 6 cm allowed if deemed safe by radiation oncologist)
- Only brain metastases present
- Previous radiotherapy to any metastasis planned for SABR, unless approved by investigator and RTQA team
- Participation in another investigational study or use of investigational device within 4 weeks before first study dose
- Previously treated brain metastases that are not stable on imaging or require steroids within 14 days before first dose
- Known contraindication to imaging tracers, contrast media, or MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
2
CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont
Haine-Saint-Paul, Belgium, 7100
Not Yet Recruiting
3
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium, 8500
Actively Recruiting
4
CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur
Namur, Belgium, 5000
Actively Recruiting
5
VITAZ St Niklaas - VITAZ- Oncology
Sint-Niklaas, Belgium, 9100
Actively Recruiting
6
Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA)
Wilrijk, Belgium, 2610
Actively Recruiting
7
IRCCS--Ospedale Bellaria-Bologna
Bologna, Italy, 40139
Not Yet Recruiting
8
Azienda Ospedaliera Santa Croce E Carle
Cuneo, Italy, 12100
Not Yet Recruiting
9
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50134
Not Yet Recruiting
10
Istituto Clinico Humanitas
Milan, Italy, 20089
Actively Recruiting
11
IRCCS - Fondazione Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
12
Azienda Sanitaria Locale Napoli 1 Centro
Naples, Italy, 80147
Not Yet Recruiting
13
AUSL Romagna - AUSL Della Romagna -Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Not Yet Recruiting
14
Azienda ospedaliero Univ Policlinico Umberto I
Rome, Italy, 00161
Not Yet Recruiting
15
Institut Català d'Oncologia - Hospital Duran i Reynals
Badalona, Spain, 08916
Not Yet Recruiting
16
Hospital Universitario De Cruces
Barakaldo, Spain, 48903
Not Yet Recruiting
17
Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia
Barcelona, Spain, 08035
Actively Recruiting
18
ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
Barcelona, Spain, 08908
Actively Recruiting
19
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Spain, 35010
Actively Recruiting
20
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
21
Hospital Universitario San Carlos
Madrid, Spain, 28040
Actively Recruiting
22
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Not Yet Recruiting
23
Hospital Universitario Virgen De La Victoria
Málaga, Spain, 29010
Not Yet Recruiting
24
Kantonsspital Aarau
Aarau, Switzerland, 5001
Not Yet Recruiting
25
Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Not Yet Recruiting
26
Inselspital - Inselspital
Bern, Switzerland, 3010
Actively Recruiting
27
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Not Yet Recruiting
28
Luzerner Kantonsspital
Lucerne, Switzerland, 6004
Actively Recruiting
29
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Not Yet Recruiting
30
UniversitaetsSpital Zurich
Zurich, Switzerland, 8901
Actively Recruiting
Research Team
E
EORTC HQ
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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