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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT02999087
• Date of registration: 14/12/2016
• Prospective Registration: Yes
• Primary sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Public title: Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH) REACH
• Scientific 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
• Date of first enrolment: September 14, 2017
• Target sample size: 707
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02999087
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age = 80 years

2. Performance Status ECOG 0-1

3. Squamous cell carcinoma, previously untreated

4. Stage III, stage IVa (i.e. operable, but not operated) or IVb (non resectable)

5. Oral cavity, oropharynx, hypopharynx or larynx

6. Availability of pre-treatment tumour tissue sample (for p16 & PD -L1 expression, TILs
and immune landscape)

7. Recording of alcohol consumption and smoking history

8. Determination of the patient's ability to receive cisplatin 100 mg /m2 for 3 cycles
(fit / unfit)*

9. 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

Exclusion Criteria:

1. Nasopharyngeal, paranasal sinuses, nasal cavity tumors or thyroid cancers

2. Squamous cell carcinoma involving cervical neck nodes with unknown primary site

3. Metastatic disease (stage IVc)

4. Viral infection (HIV, Hepatitis B/C)

5. Autoimmune disease

6. Immunodeficiency or immunosuppressive therapy

7. Active CNS disease

8. Interstitial lung disease

9. Active infection

10. 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

11. 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)

12. Concurrent treatment with any other systemic anti-cancer therapy that is not specified
in the protocol

13. Concomitant treatment with any drug on the prohibited medication list such as live
vaccines

14. History of other malignancy within the last 3 years (exception of in situ carcinoma
and skin carcinomas)

15. 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

16. Known hypersensitivity reaction to study drugs

17. 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

HNSCC

Intervention(s)

Radiation: IMRT

Drug: avelumab

Drug: Cetuximab

Drug: Cisplatin

Primary Outcome(s)

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]

Secondary Outcome(s)

Safety: acute adverse events graded by NCI CTCAE v4.03 [Time Frame: From date of randomization to end of study, assessed up to 74 months]

Overall survival [Time Frame: From date of randomization until the date of death from any cause, assessed up to 74 months]

Secondary ID(s)

GORTEC 2017-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UNICANCER