Trials Sponsors Conditions Drugs Pricing

Conditions

Locally advanced head and neck squamous cell carcinoma (LA-HNSCC)

Outcome Measures

Primary Outcomes (1)

EFS rate at 2-years in MRD-positive patients (interventional cohort) where EFS rate is defined as the proportion of patients who have not experienced any EFS event at 2 years after MRD assessment (i.e., after CRT).

Secondary Outcomes (5)

Frequency and severity of TEAEs, irAEs, IRRs, serious AEs (SAE) TEAE/SAEs leading to dose delays, withdrawal or death. Clinically significant changes in laboratory, vital signs, and safety assessment parameters.
Change from baseline in QoL as assessed by the EORTC QLQ-C30 and QLQ-HN43. Participant-reported frequency and severity of symptomatic toxicity based on PRO-CTCAE and FACT-GP5 and frequency distribution of PGIS/PGIC over time.
Correlation of post-CRT ctDNA-based MRD status, ctDNA longitudinal changes (such as molecular response) with clinical activity and response. Change of ctDNA status (approx. every 3 months).
OS defined as the time from post-CRT MRD assessment to death from any cause.
EFS is defined as the time from post-CRT MRD assessment to disease progression, recurrence, or death from any cause, whichever comes first

Interventions

EzabenlimabType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Ezabenlimab
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Ezabenlimab
Named ingredient: Ezabenlimab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Observational cohort : Patients ≥ 18 years old and must be able to give written informed consent.
Observational cohort : Newly diagnosed locally advanced histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx eligible for curative-intent, platinum-based chemotherapy plus radiotherapy

Sponsors & Collaborators

Cliniques Universitaires Saint-Luc
Type not reportedlead

Study Sites (10)

Grand Hopital De Charleroi

Charleroi, 6060, Belgium

Aurélie Louvet+3260119472 Aurelie.louvet@ghdc.be

Centre hospitalier universitaire de Liege

Liege, 4000, Belgium

Aurélie Poncin+3243233558 aponcin@chuliege.be

Universitair Ziekenhuis Gent

Gent, 9000, Belgium

Michael Saerens+3293322692

Central Study Contacts

Dr Rachel Galot

+3227641037 rachel.galot@saintluc.uclouvain.be

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

March 10, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-523575-36-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:34:36 UTC

Documents

D1_Protocol_2025-523575-36-00_redacted

You may not qualify if:

Observational cohort : Has received prior radiation therapy, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.
Observational cohort : Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer.
Observational cohort : Has a diagnosed and/ or treated any additional malignancy within the last 2 years prior to registration. Exceptions: localized HNSCC treated by curative surgery alone, curatively treated superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, non-melanoma skin cancer or localized cervical cancer or localized and presumed cured prostatic cancer or basal cell carcinoma of the skin and carcinoma in situ of the cervix or bladder).
Observational cohort : Woman who is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment.
Interventional cohort : Meets criteria of PD according to local standards. Patients that need to undergo lymph node dissection according to SOC will not be excluded.
Interventional cohort : Any unresolved toxicity CTCAE >/= Grade 2 from the prior CRT. Participants with irreversible or slowly resolving toxicity Grade 2 that is not reasonably expected to be exacerbated by study drug may be included (e.g., hearing loss, neuropathy), after consultation with the study coordinators.
Interventional cohort : Known diagnosis of immune deficiency or a positive serology of HIV (HIV 1/2 antibodies).
Interventional cohort : Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) or pre-existing liver cirrhosis.
Interventional cohort : Known history of active tuberculosis (TB; Bacillus tuberculosis).
Interventional cohort : Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis/interstitial lung disease.
Interventional cohort : Other uncontrolled active illnesses or nonmalignant systemic disease (examples include, but are not limited to, active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome …).
Interventional cohort : Has Grade 3-4 bleeding due to underlying malignancy or has high risk of bleeding (examples include but not limited to tumors encasing or infiltrating a major vessel (i.e., carotid artery, jugular vein) and/or other high-risk features such as an arteriovenous fistula. Patients with disease in such locations or with these features are not eligible for participation.
Interventional cohort : Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Interventional cohort : Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Note: Corticosteroid use on study for management of AEs and SAEs, as a premedication, for the administration of chemotherapies, and/or a premedication for IV contrast, allergies/reactions or if considered necessary for a participant’s welfare is allowed.
Interventional cohort : If participant have undergone major surgery, they must have adequately recovered from all procedure-related toxicities and/or complications prior to starting therapy. .
+9 more criteria

Phase II study of ezabenlimab in patients with PD-L1-positive head and neck cancer with residual disease detected by ctDNA after chemoradiotherapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations