AzTrials
AzTrials

HNSCCPhase 2REWRITeNCT03726775

Trial Evaluating the Tolerance and Safety of Durvalumab - RT Combination for Treatment in SCCHN

A Phase 2 study testing Durvalumab in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HNSCC
What is being tested?
Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
2 sitesFrance
Study dates
17 Jul 2019to 9 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age > 18 years with no upper limit
  • Performance Status ECOG 0-2
  • Squamous cell carcinoma, previously untreated
  • T1-T4 with clinical status N0-N1 or N2a-N2b non palpable, with only homolateral lymph node in radiological examinations.
  • Patient with at least one of these fragility criteria :
  • o Status ECOG 1 with multiple comorbidities, at least 2 pathologies with grade ≥ 2 (renal and/or cardiac and/or vascular and/or hepatic, and/or,neurologic, and/or pulmonary)
Show all 25Show fewer
  • o Status ECOG = 2
  • o Age ≥ 70 , judged unfit with oncogeratric evaluation by EGE (ELAN Geriatric Evaluation) test or unable to receive cisplatine or Carboplatine- 5FU (at least one criteria listed below)
  • Criteria for determining if a patient is unfit for receiving cisplatine or carbo-5FU :
  • Calculated creatinine clearance ≤ 60 mL/min as determined by the modified. method of Cockcroft and Gault or glomerular filtration rate ≤ 60 mL/min/1.73m² (CKD-EPI method recommended)
  • Haemoglobin < 10 g/dL, aspartate (AST) and alanine transaminase (ALT) more than 2 times the upper limit of the normal range (ULN), serum albumin ≤35 g/L, Absolute neutrophil count ≤ 1 500/μL, platelets ≤ 100 000/μL or total bilirubin ≥ 1.5 mg/dL
  • Cardiac function not compatible with hyperhydration or significant heart disease
  • Weight loss > 15% in 2 months
  • Oral cavity, oropharynx, hypopharynx or larynx
  • Availability of pre-treatment tumor tissue sample (for PD-L1 expression, TILs and immune landscape)
  • Documentation of p16 disease (HPV status for oropharyngeal tumor)
  • Recording of alcohol consumption and smoking history
  • Glomerular filtration rate (GFR) >40 mL/min/1.73m2 (CKD-EPI method recommended) or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula
  • Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations during the follow up period
  • Patient able to understand French and complete the quality of life questionnaires or who can be helped by a support person if necessary.
  • Must have a life expectancy of at least 12 weeks
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • 1) Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and folliclestimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • 2) Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • 15. Written informed consent obtained prior to performing any protocol-related procedures, including screening evaluations

Who cannot join

  • Nasopharyngeal, paranasal sinuses, nasal cavity tumors or thyroid cancers
  • Metastatic disease
  • Active CNS disease
  • Any prior or current treatment for invasive head and neck cancer
  • Any unresolved toxicity NCI CTCAE v5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis
Show all 31Show fewer
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the investigator
  • Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
  • History of leptomeningeal carcinomatosis
  • Body weight ≤ 30 kg and/or weight loss of ≥ 15% 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 within 30 days prior to the first dose of IP
  • Known allergy or hypersensitivity reaction to study drug or any of the study drug excipients
  • Prior organ transplantation including allogenic stem-cell transplantation
  • Other severe acute or chronic medical conditions including pneumonitis, pulmonary fibrosis
  • Active autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc])
  • Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥ 5 years
  • Adequately treated non-melanoma skin cancer
  • Adequately treated carcinoma in situ without evidence of disease
  • History of active primary immunodeficiency
  • Ongoing or active infection including tuberculosis, hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections
  • Systemic corticosteroids < 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy
  • Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
  • Individual deprived of liberty, or under any kind of guardianship
  • Inclusion in another study research on drug or medical device

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Institut Sainte Catherine

    Avignon, 84082

  • Centre Eugene Marquis

    Rennes, 35042

Other trials in France

About this study

Official title: A Phase II Trial of Radiotherapy (RT)-Durvalumab Without Prophylactic Neck Irradiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN.

Read the detailed description

There is a strong rationale for testing this new paradigm of RT for SCCHN without prophylactic neck irradiation, being replaced by immune stimulation via the combination of RT and Programmed Death-1 (PD-L1) inhibition with durvalumab, due to:

  • The unmet medical need for new treatments, better tolerated and " as " or " more " effective than the current Standard Of Care (SOC)
  • The need to decrease radiation-induced toxicity, especially in fragile patients
  • The added toxicity due to elective nodal irradiation
  • The strong rationale to combine RT and PD-L1 inhibition
  • The potential immune suppressive effect of large field prophylactic neck irradiation

It is hypothesized this innovative concept to be safe in the context of this study for the following reasons:

  • The rate of relapse in the neck is expected to be low in Magnetic Resonnance Imaging (MRI) \& PET-CT N0 neck
  • A non-irradiated neck can be easily monitored, clinically and by imaging
  • Most of the potential relapses in the neck are expected to be salvaged by surgery and/or RT
  • The preventive irradiation of N0 regions is not anymore performed for others lymphophilic cancers (lymphoma, Non-Small Cell Lung Cancer (NSCLC)).

The combination of durvalumab with RT restricted to the primary tumor site and immediate adjacent nodal area will achieve a similarly regional (nodal) control rate than standard RT including large prophylactic neck irradiation (regional recurrence < 10 %.

This study will include patients with early (T1-T2 N0) or locally advanced SCCHN (T3-4 N0), histologically proven who had not received previous treatment for this setting. The study is designed with the primary objective of demonstrating that RT without large prophylactic irradiation in combination with durvalumab is effective in terms of regional control. All patients will be followed until death or at least 36 months.

Conditions
HNSCC
Being tested
Durvalumab
Keywords
durvalumab, without prophylactic
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • DurvalumabDrug

    Also called MEDI4736

    Infusion of durvalumab during RT and after RT during 6 months

Study groups in NCT03726775
Study groupRoleWhat they receive
RT-durvalumabExperimentaldurvalumab at fixed dose of 1120 mg on Day1 of RT and every 3 weeks during the RT. Durvalumab with be continued at a fixed dose of 1500 mg every 4 weeks during 6 months following RT.
Receives: Drug: Durvalumab

What is being measured

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

  1. Regional (neck) nodal control rate

    Cervical Node Control in the non-irradiated N0 neck

    Measured: 1 year

Secondary outcomes (5)

  1. Recurrence and control rates analysis

    Estimation of local, regional, locoregional control

    Measured: 3, 6, 12, 18, 24 and 36 months

  2. Survival analyses

    Estimation of the survival rates and the 95% confidence intervals (95% CI)

    Measured: 3, 7, 11, 15, 19, 23, 27, 31, and 36 months post RT

  3. Objective Response Rate

    complete or partial response according to RECIST 1.1 criteria

    Measured: 3, 12, 24 et 36 months post RT

  4. Quality of life QLQC30

    To evaluate the effectiveness of support

    Measured: baseline, 3-month, 12-month and 24-month post RT

  5. Quality of life QLQ-H&N35

    To evaluate the effectiveness of support

    Measured: baseline, 3-month, 12-month and 24-month post RT

Timeline

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

  1. First posted31 Oct 2018
  2. Study start17 Jul 2019
  3. Primary completion9 Mar 2026
  4. Study completion9 Mar 2026

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
IV infusion of durvalumab will start at fixed dose on Day1 of RT and subsequently every 3 weeks during the course of RT. Durvalumab with be continued via IV infusion at a fixed dose for an additional 6 months following RT, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03726775
Sponsor's protocol ID
GORTEC 2018-02
Acronym
REWRITe
Status last verified
Sep 2026
First submitted
25 Oct 2018
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 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 25 inclusion and 31 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: finished, 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 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Regional (neck) nodal control rate (time frame: 1 year). 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 NCT03726775.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in