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HNSCCPhase 3REACHNCT02999087

Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH)

A Phase 3 study testing Cetuximab, avelumab and Cisplatin in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
HNSCC
What is being tested?
Cetuximab, avelumab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
707 participants
Where
1 siteFrance
Study dates
14 Sep 2017to Dec 2027
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≤ 80 years
  • Performance Status ECOG 0-1
  • Squamous cell carcinoma, previously untreated
  • Stage III, stage IVa (i.e. operable, but not operated) or IVb (non resectable)
  • Oral cavity, oropharynx, hypopharynx or larynx
  • Availability of pre-treatment tumour tissue sample (for p16 \& PD -L1 expression, TILs and immune landscape)
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  • Recording of alcohol consumption and smoking history
  • Determination of the patient's ability to receive cisplatin 100 mg /m2 for 3 cycles (fit / unfit)*
  • Written informed consent
  • Criteria for determining if a patient is fit for receiving high dose cisplatin:
  • Calculated creatinin clearance ≥ 60 mL/min as determined by the modified. method of Cockcroft and Gault or by the EDTA method
  • Absolute neutrophil count ≥1 500/μL, platelets ≥100 000/μL, hemoglobin ≥ 10 g/dL, aspartate (AST) and alanine transaminase (ALT) less than 2 times the upper limit of the normal range (ULN), total bilirubin ≤ 1.5 mg/dL, serum albumin > 35 g/L
  • Peripheral neuropathy < grade 2
  • No clinical hearing loss (confirmed by audiogram)
  • Cardiac function compatible with hyperhydration; Left ventricular ejection fraction within the institutional normal ranges as measured by echocardiogram

Who cannot join

  • Nasopharyngeal, paranasal sinuses, nasal cavity tumors or thyroid cancers
  • Squamous cell carcinoma involving cervical neck nodes with unknown primary site
  • Metastatic disease (stage IVc)
  • Viral infection (HIV, Hepatitis B/C)
  • Autoimmune disease
  • Immunodeficiency or immunosuppressive therapy
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  • Active CNS disease
  • Interstitial lung disease
  • Active infection
  • Any prior or current treatment for invasive head and neck cancer. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior surgical resection or RT, or use of any investigational agent
  • Weight loss of > 10% during the last 4 weeks (except if renutrition with a feeding tube is planned before the onset of treatment or is ongoing)
  • Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol
  • Concomitant treatment with any drug on the prohibited medication list such as live vaccines
  • History of other malignancy within the last 3 years (exception of in situ carcinoma and skin carcinomas)
  • 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
  • Known hypersensitivity reaction to study drugs
  • Any social, personal, medical and/or psychological 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Bretagne Sud

    Lorient, 56322

Other trials in France

About this study

Official title: A Phase III Randomized Trial of Avelumab-cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN.

Read the detailed description

This open-label, randomized, controlled, multicenter phase III study will include 688 patients with LA SCCHN (420 fit for HD cisplatin and 268 unfit for HD cisplatin), histologically confirmed who had not received previous treatment for this setting. The study is designed with the primary objective of demonstrating that treatment with avelumab in combination with cetuximab-RT is superior to SOC Cisplatin-RT or cetuximab-RT alone in terms of PFS. Randomization will assign the 2 treatment arms of each cohort with a 1:1 ratio. In each cohort (fit for cisplatin and unfit for cisplatin), the randomization will be stratified for the 2 most established prognostic factors N stage (N0-N1 vs N2-3) and p16 expression (OPC p16+ versus OPC p16- or non OPC). All patients will be followed until death or at least 60 months.

Conditions
HNSCC
Being tested
Cetuximab, avelumab, Cisplatin, IMRT
Keywords
Head and Neck cancer, Immunotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

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

  • CetuximabDrug

    Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of RT.

  • avelumabDrug

    IV infusion of avelumab (10 mg/kg over 1 hour) once every 2 weeks. Avelumab will start on Day-8 together with cetuximab and subsequently every 2 weeks during the course of RT. Avelumab with be continued every 2 weeks for an additional 12 months following RT.

  • CisplatinDrug

    100 mg/m² IV after hyperhydration and at a maximal rate of 1 mg/min, on days 1, 22, 43.

  • IMRTRadiation

    RT will be performed using IMRT (intensity modulated radiotherapy), with a simultaneous integrated boost (SIB) technique. RT dose to the GTV will be 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions). Prophylactic dose will be 52.8 Gy in 1.6 Gy daily fractions over 6.5 weeks (33 fractions).

Study groups in NCT02999087
Study groupRoleWhat they receive
Arm A Patient FITActive comparatorLead-in phase (Day-8) : no treatment Concomitant radiotherapy phase : Radiotherapy by IMRT + cisplatin 100mg/m2 Maintenance phase : no treatment until follow-up phase
Receives: Drug: Cisplatin; Radiation: IMRT
Arm B Patient FITExperimentalLead-in phase (Day-8) : Cetuximab 400mg/m2 and avelumab 10mg/kg Concomitant radiotherapy phase : Radiotherapy by IMRT + cetuximab 250mg/m2 and avelumab 10mg/kg Maintenance phase : avelumab 10mg/kg every 2 weeks during 12 months
Receives: Drug: Cetuximab; Drug: avelumab; Radiation: IMRT
Arm C Patient UNFITExperimentalLead-in phase (Day-8) : Cetuximab 400mg/m2 and avelumab 10mg/kg Concomitant radiotherapy phase: Radiotherapy by IMRT + cetuximab 250mg/m2 and avelumab 10mg/kg Maintenance phase : avelumab 10mg/kg every 2 weeks during 12 months
Receives: Drug: Cetuximab; Drug: avelumab; Radiation: IMRT
Arm D Patient UNFITActive comparatorLead-in phase (Day-8): Cetuximab 400mg/m2 Concomitant radiotherapy phase: Radiotherapy by IMRT + cetuximab 250mg/m2 Maintenance phase : no treatment until follow-up phase
Receives: Drug: Cetuximab; Radiation: IMRT

What is being measured

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

  1. Progression free survival

    Time between randomization and the first event among progression (per modified Response Evaluation Criteria in Solid Tumors (RECIST) version v1.1) and death, whatever the cause of death.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months

Secondary outcomes (2)

  1. Overall survival

    Measured: From date of randomization until the date of death from any cause, assessed up to 74 months

  2. Safety: acute adverse events graded by NCI CTCAE v4.03

    Measured: From date of randomization to end of study, assessed up to 74 months

Timeline

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

  1. First posted21 Dec 2016 (estimated)
  2. Study start14 Sep 2017
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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
707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999087
Sponsor's protocol ID
GORTEC 2017-01
Acronym
REACH
Status last verified
Sep 2026
First submitted
14 Dec 2016
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tao Y, Auperin A, Sun X, Sire C, Martin L, Coutte A, Lafond C, Miroir J, Liem X, Rolland F, Even C, Nguyen F, Saada E, Maillard A, Colin-Batailhou N, Thariat J, Guigay J, Bourhis J. Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH). Eur J Cancer. 2020 Dec;141:21-29. doi: 10.1016/j.ejca.2020.09.008. Epub 2020 Oct 24.

    PubMed 33125944

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetuximab, avelumab and Cisplatin in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site 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 15 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months). 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 NCT02999087, which also lists 1 linked publication.

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 2 Oct 2026.

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