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

NCT03726775 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: GORTEC 2018-02
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HNSCC

Keywords

durvalumab; without prophylactic

Outcome Measures

Primary Outcomes (1)

• Regional (neck) nodal control rate

  Cervical Node Control in the non-irradiated N0 neck

  1 year

Secondary Outcomes (5)

• Recurrence and control rates analysis

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

• Survival analyses

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

• Objective Response Rate

  3, 12, 24 et 36 months post RT

• Quality of life QLQC30

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

• Quality of life QLQ-H&N35

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

Study Arms (1)

RT-durvalumab

EXPERIMENTAL

durvalumab 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.

Drug: Durvalumab

Interventions

Durvalumab DRUG

Infusion of durvalumab during RT and after RT during 6 months

Also known as: MEDI4736

RT-durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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
• Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis
• 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 \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\])

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• UNICANCER: collaborator
• Center Eugene Marquis: collaborator

Study Sites (2)

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 31, 2018
• Study Start: July 17, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

FR (2)