Study of advacned resectable head and neck cancer with immunotherapy and radiotherapy before surgery

Induction Durvalumab (MEDI4736) & Radiotherapy (RT) for Locally Advanced but Resectable Head and Neck Squamous Cell Carcinomas: A Pilot Study - ESR-17-12933

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001641-40-IT

Enrollment

Registered

2021-05-24

Start date

2019-09-09

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced resectable head and neck tumor MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Imfinzi Product Name: IMFINZI Product Code: [DURVALUMAB] Pharmaceutical Form: Lyophilisate for solution for injection CAS Number: 1428935-60-7 Current Sponsor code: MEDI 4736 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Newlydiagnosed,histologicallyconfirmedsquamouscellcarcinomaoftheoralcavity,pharynxand larynx; • Selected UICC stage IV disease limited to T1-3N2-3 or T4N1-3disease; • No distant metastases (M0) • Lesions (both primary and nodal) must be considered amenable of complete surgicalresection; • Patient must be cleared for surgery (medicallyoperable); • Age >18 yrs and 30kg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: • cN0 disease even if stage IV; • Definitive clinical or radiologic evidence of distant metastatic disease(M1); • Carcinoma of the head and neck of unknown primary site origin or lack of a visible primarysite; • Prior head neck regionirradiation; • Synchronous primarycancers; • Any other previous malignancy within 5years; • Active, known, or suspected autoimmune disease. Type I diabetes mellitus, hypothyroidismonly requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the extent by which the administration of neoadjuvant Durvalumab plus fractionated radiotherapy modulates immunobiomarkers, such as T- cell activation, serum cytokines in peripheral blood as well as tumor pathological response and T-cell infiltration in the tumor and to confirm the safety of CBIT as a single agent in combination with RT.;Secondary Objective: 1. Local and regional activity of neoadjuvant Durvalumab/RT at clinical/radiological (morphologicalandfunctional) examination before surgery. 2. Safety of combination in terms of surgery 3. Feasibility of adjuvant radiotherapy + chemotherapy after surgery;Primary end point(s): Immunobiomarkers modulation;Timepoint(s) of evaluation of this end point: Baseline, day 4, 18, 28, before and after postoperative radiotherapy	—

Measure

Time frame

Main Objective: To determine the extent by which the administration of neoadjuvant Durvalumab plus fractionated radiotherapy modulates immunobiomarkers, such as T- cell activation, serum cytokines in peripheral blood as well as tumor pathological response and T-cell infiltration in the tumor and to confirm the safety of CBIT as a single agent in combination with RT.;Secondary Objective: 1. Local and regional activity of neoadjuvant Durvalumab/RT at clinical/radiological (morphologicalandfunctional) examination before surgery. 2. Safety of combination in terms of surgery 3. Feasibility of adjuvant radiotherapy + chemotherapy after surgery;Primary end point(s): Immunobiomarkers modulation;Timepoint(s) of evaluation of this end point: Baseline, day 4, 18, 28, before and after postoperative radiotherapy

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Countries

Italy

Contacts

Public ContactClinical Trial Center

Istituti Fisioterapici Ospitalieri

filomena.spasiano@ifo.gov.it0652665664

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026