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Squamous Cell Carcinoma of Head and NeckPhase 3PembroMetaRTNCT04747054

Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers

A Phase 3 study testing Pembrolizumab, Loco-regional radiotherapy and Chemotherapy in people with Squamous Cell Carcinoma of Head and Neck, run by UNICANCER at 26 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Pembrolizumab, Loco-regional radiotherapy and Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
26 sitesFrance
Study dates
1 Dec 2021to 1 Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have signed a written informed consent form prior to any study specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
  • Histologically confirmed squamous cell carcinoma of head and neck (oral cavity, oropharynx, hypopharynx, and larynx) including unknown primary head and neck lymph nodes with distant metastases at presentation (T1-4 N0-3 M1). Histological confirmation is required in case of a single metastatic lesion.
  • Eligible for treatment by pembrolizumab according to the European Marketing Authorization
  • Patient ≥18 years old
  • Performance status: 0-1 (WHO)
  • Combined Positive Score (CPS) ≥1 for primary tumor (as determined per local practice)
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  • Subjects must have at least one measurable lesion as per RECIST v1.1 to assess efficacy
  • Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization:
  • If randomization is done before treatment start: i. Absolute neutrophil count ≥1.5 × 10⁹/L ii. Platelet ≥100 × 10⁹/L iii. Hemoglobin ≥90 g/L iv. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT), ≤3 × upper limit of normal (ULN), (unless documented liver metastases where ≤5 x ULN is permitted) v. Bilirubin ≤1.5 × ULN. vi. Serum albumin ≥25 g/L vii. Creatinine clearance ≥30 mL/min (calculated per institutional guidelines or by Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula) viii. Corrected serum calcium of ≤11.5 mg/dL or ≤2.6 mmol/L. b. If randomization if done after treatment start i. Absolute neutrophil count ≥1.0 × 10⁹/L ii. Platelet ≥75 × 10⁹/L iii. Hemoglobin ≥85 g/L
  • Patient must agree to use adequate contraception methods for the duration of the study treatment and up to 4 months after the last dose of pembrolizumab administration
  • Patients must be affiliated to a Social Security System (or equivalent)
  • No disease progression during systemic treatment if the randomization is done after the start of pembrolizumab for the current disease

Who cannot join

  • Symptomatic central nervous system (CNS) metastases and / or carcinomatous meningitis
  • History of another malignancy within 2 years prior to study inclusion, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma
  • Prior radiotherapy in the head and neck region
  • Any prior or current non-surgical treatment for invasive head and neck cancer. (except for pembrolizumab +/- chemotherapy for the current cancer for a maximum of 6 cycles). This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, chemotherapy, anti-PD-1/PD-L1 and CTLA-4, prior radiotherapy (RT), or use of any investigational agent. Loco-regional recurrent or second primary head and neck cancer after prior surgical treatment alone in the head and neck region could be eligible.
  • Known Acquired Immune Deficiency Syndrome (AIDS)
  • Known currently active infection including hepatitis B or hepatitis C
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  • Patient having received live attenuated vaccine within 28 days prior to enrolment
  • Pregnant or breast feeding woman
  • Active autoimmune disease except vitiligo, type-1 diabetes, hypothyroid stabilized with hormonal substitution, or psoriasis which do not require systemic treatment
  • Active immunodeficiency or ongoing immunosuppressive therapy
  • Active symptomatic interstitial lung disease
  • Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial
  • Any social, personal, medical, geographic and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent
  • Prior organ transplantation including allogenic stem-cell transplantation
  • Other severe acute or chronic medical conditions including colitis, pneumonitis, pulmonary fibrosis or psychiatric conditions including active suicidal ideation; or laboratory abnormalities that may increase the risk associated with study participation and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • Person deprived of their liberty or under protective custody or guardianship
  • Patient who have taken any investigational medicinal product or have used an investigational device within 30 days prior to study inclusion

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

NICOLAS DE SOUSA CARVALHO contact

0171936709

n-de-sousa@unicancer.fr

LAURE MONARD contact

01 73 79 73 09

l-monard@unicancer.fr

26 sites in 1 country

France26 sites, 24 recruiting

  • Institut Sainte Catherine

    Avignon, 84000

    Benoit CALDERON, Dr

    Recruiting

  • CHU Jean Minjoz

    Besançon, 25030

    Salim BENHMIDA

    Recruiting

  • CHU Bordeaux

    Bordeaux, 33075

    Amaury DASTE, Dr

    Recruiting

  • Institut Bergonié

    Bordeaux

    Pauline GUILLON, Dr

    Recruiting

  • Centre François Baclesse

    Caen, 14076

    Juliette THARIAT, Dr

    Recruiting

  • CH Carcassonne

    Carcassonne, 1A810

    Samir HACENE, Dr

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Hervé DEVAUD, Dr

    Recruiting

  • Centre Georges François Leclerc

    Dijon

    Noémie VULQUIN, Dr

    Recruiting

  • Centre Guillaume le Conquérant

    Le Havre

    Suspended

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans

    Yoann POINTREAU, Dr

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Xavier LIEM, Pr

    Recruiting

  • Groupe Hospitalier Bretagne Sud

    Lorient

    Christian SIRE, Dr

    Recruiting

  • Centre Léon Bérard

    Lyon

    Withdrawn

  • Hopital de la Timone

    Marseille

    Sebastien SALAS, Pr

    Recruiting

  • Hopital Nord Franche Comté - Site de Mittan

    Montbéliard, 25209

    Xushan SUN, Dr

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Cyrielle SCOUARNEC, Dr

    Recruiting

  • Institut Jean Godinot

    Reims, 51726

    Alain PREVOST, Dr

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Florian CLATOT, Dr

    Recruiting

  • CHU de Saint Etienne

    Saint-Priest-en-Jarez, 42270

    Eric JADAUD, Dr

    Not yet recruiting

  • Institut de Cancérologie Strasbourg-Europe

    Strasbourg

    Mickael BURGY, Dr

    Recruiting

  • Polyclinique de l'Ormeau

    Tarbes, 65000

    Pierre-Marie PIALAT, Dr

    Not yet recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Anouchka MODESTO, Dr

    Recruiting

  • Hopital Privé Drome Ardeche

    Valence, 26000

    Matthieu BOSSET, Dr

    Not yet recruiting

  • CH Valence

    Valence, 26953

    Rim BATTI, Dr

    Not yet recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Yolanda FERNADEZ DIEZ, Dr

    Recruiting

  • Gustave Roussy

    Villejuif

    Yungan TAO, Dr

    Caroline EVEN, Dr

    Recruiting

Other trials in France

About this study

Official title: Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Alone or With Chemotherapy Versus Systemic Treatment Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases

Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers

Read the detailed description

Comparative interventional prospective phase 3, randomised, open-label, multicentric trial comparing the combination of radiotherapy and pembrolizumab alone or with chemotherapy to systemic treatment as first line treatment of patients with newly diagnosed head and neck squamous cell carcinoma with synchronous metastases.

Being tested
Pembrolizumab, Loco-regional radiotherapy, Chemotherapy
Keywords
Metastatic, Radiotherapy, pembrolizumab, Squamous Cell Carcinoma, Head and Neck, Carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Carcinoma, Squamous Cell, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called KEYTRUDA

    Pembrolizumab 200 mg every 3 weeks until disease progression (as confirmed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)) or unacceptable toxicity. The treatment of pembrolizumab should not be delayed because of radiotherapy planning.

  • Loco-regional radiotherapyRadiation

    Depending on the choice of radiotherapy timing:

    • Before 3 cycles of pembrolizumab with or without chemotherapy : radiotherapy could start at any time between one week after the first administration of pembrolizumab and the first day of the 3rd cycle.
    • After 3 cycles of pembrolizumab with or without chemotherapy : radiotherapy could start at any time after 3rd cycle (C3D1) and up to a maximum of 4 weeks after the 6th cycle of pembrolizumab.

    Dose/fraction of radiotherapy: 54 Gy/18 fractions (recommended schedule) or 70Gy/33-35 fractions or other curative dose/fraction schedules with shorter duration and biologically equivalent dose of at least 60Gy at the discretion of local investigators, in the head and neck region. The volume of RT will include only involved loco-regional tumor region and no prophylactic neck volume will be necessary. Other cycles of pembrolizumab will be administered during and after radiotherapy.

  • ChemotherapyDrug

    If the investigator decide to add chemotherapy with pembrolizumab, and depending on the radiotherapy timing:

    • Start of radiotherapy planned before 3rd cycle: Chemotherapy could be delayed after the end of radiotherapy and start from cycle 3 or 4 of pembrolizumab. Administration of chemotherapy can be delayed in case of non resolved grade 3 or higher toxicity from radiotherapy.
    • Radiotherapy planned after 3rd cycle: Chemotherapy should start at the same time of pembrolizumab.

    Chemotherapy will combine carboplatin AUC 5mg/mL/min or cisplatin 100mg/m² every 3 weeks with 5-FU 1000mg/m²/j during 4 days every 3 weeks for a maximum of 6 cycles

Study groups in NCT04747054
Study groupRoleWhat they receive
Radiotherapy added to systemic treatmentExperimentalPembrolizumab 200mg every 3 weeks until disease progression or unacceptable toxicity. Loco-regional radiotherapy(RT) depending on the RT timing : * Before 3 cycles of pembrolizumab: RT could start at any time between one week after the first administration of pembrolizumab and the first day of the 3rd cycle. * After 3 cycles of pembrolizumab: RT could start at any time after 3rd cycle and up to a maximum of 4 weeks after the 6th cycle of pembrolizumab. If the investigator decides before randomization to add chemotherapy and depending on the RT timing: * Start of RT planned before 3rd cycle: Chemotherapy could be delayed after the end of RT and start from cycle 3 or 4 of pembrolizumab. * RT planned after 3rd cycle: Chemotherapy should start at the same time of pembrolizumab. Chemotherapy will be composed of carboplatin AUC 5 mg/mL/min or cisplatin 100 mg/m² every 3 weeks with 5-fluorouracil (5-FU) 1000mg/m²/day during 4 days every 3 weeks for a maximum of 6 cycles
Receives: Drug: Pembrolizumab; Radiation: Loco-regional radiotherapy; Drug: Chemotherapy
Systemic treatmentActive comparatorPembrolizumab 200 mg every 3 weeks until disease progression or unacceptable toxicity. If the investigator decides before randomization to add chemotherapy with pembrolizumab, the chemotherapy will be composed of carboplatin area under the curve (AUC) 5 mg/mL/min or cisplatin 100 mg/m² every 3 weeks with 5-FU 1000 mg/m²/day during 4 days every 3 weeks for a maximum of 6 cycles
Receives: Drug: Pembrolizumab; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

    Measured: From randomization to disease progression or death, up to 3 years.

Secondary outcomes (9)

  1. Overall survival (OS)

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether the radiotherapy improves overall survival compared to standard of care.

    Measured: From randomization to death from any cause, up to 5 years.

  2. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At baseline, 4 months, 6 months, 12 months, 18 months, 2 years, 3 years, and 4 years

  3. Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35)

    The head \& neck cancer module is a 35-item questionnaire designed for use among a wide range of patients with head \& neck cancer, varying in disease stage and treatment modality. It includes 7 multi-item scales that assess pain (4 items), swallowing (4 items), senses (2 items), speech (3 items), social eating (4 items), social contact (5 items), and sexuality (2 items). There are also 11 single items. Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms. For all items and scales, high scores indicate more problems.

    Measured: At baseline, 4 months, 6 months, 12 months, 18 months, 2 years, 3 years, and 4 years

  4. Objective response rate (ORR)

    The Objective response rate is defined as the presence of a partial response (PR) or complete response (CR) observed at week 18 and at week 27 after randomization. The investigator will evaluate the objective response using RECIST v1.1.

    Measured: At 18 weeks and 27 weeks

  5. Loco-regional progression

    Locoregional disease progression is defined as the time from randomization to the first documented locoregional progression evaluated by RECIST v1.1.

    Measured: From randomization to loco-regional progression, up to 5 years.

  6. Distant progression

    Distant progression is defined as the time from randomization to the first documented distant disease progression evaluated by RECIST v1.1.

    Measured: From randomization to distant progression, up to 5 years.

  7. Progression-free survival 2 (PFS2)

    Progression-free survival 2 is defined as time from randomization to a second tumor progression (according to RECIST V1.1) on next-line treatment (given after a first progression) or death from any cause. Patients who did not have a progression after the initial treatment are counted as an event at the time of death if they died whatever the cause of death or are censored at the time of last news if they are alive. Patients who had a progression after the initial treatment are counted as an event when they progressed again under or after the treatment of the first progression (if they start a new treatment, i.e. a third treatment, they are also counted as an event) or when they died whatever the cause of death or they are censored at the time of last news if they are alive without new progression after the first progression.

    Measured: Up to 5 years after randomization.

  8. Incidence of Treatment Adverse Events

    The tolerance and safety will be evaluated by toxicity (acute [<1 months after the end of pembrolizumab] and late [≥1 month after the end of pembrolizumab]), assessed using the Common terminology criteria for adverse events version 5.0 (CTCAE v5.0).

    Measured: Throughout study completion, up to 5 years.

  9. Compliance to treatment

    Compliance to treatment is defined by the difference on received study regimen compared to the planned study regimen.

    Measured: Throughout study treatment, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start1 Dec 2021
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04747054
Sponsor's protocol ID
UC-HNG-2007
Other IDs
2020-A02221-38
Acronym
PembroMetaRT
Status last verified
Jul 2026
First submitted
5 Feb 2021
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Loco-regional radiotherapy and Chemotherapy in people with Squamous Cell Carcinoma of Head and Neck, run by UNICANCER at 26 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact NICOLAS DE SOUSA CARVALHO (0171936709, n-de-sousa@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From randomization to disease progression or death, up to 3 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04747054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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