Recruiting NCT06129864

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

Phase III Interventional Locally Advanced Head and Neck Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: volrustomig.
Who it may be relevant to: Registry conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma. Basic parameters: 18 years — 130 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Austria, Belgium, Brazil, Canada +18
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

Overview

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

Interventions

Drug volrustomig
volrustomig

Primary outcome measures

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors [Time frame: Up to approximately 8 years]

Secondary outcome measures (12)

Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population [Time frame: Up to approximately 8 years]
Landmark Progression-Free Survival (PFS) Rates [Time frame: Up to approximately 8 years]
Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors [Time frame: Up to approximately 8 years]
Landmark Overall Survival (OS) Rates [Time frame: Up to approximately 8 years]
Overall Survival (OS) in the unresected LA-HNSCC ITT population [Time frame: Up to approximately 8 years]
Progression Free Survival 2 (PFS2) [Time frame: Up to approximately 8 years]
Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum [Time frame: Up to approximately 8 years]
Participant-reported physical functioning [Time frame: Up to approximately 8 years]
Participant-reported global health status (GHS)/quality of life (QoL) [Time frame: Up to approximately 8 years]
Percentage of participants with Adverse Events [Time frame: Up to approximately 8 years]
Area under the curve (AUC) [Time frame: Up to approximately 8 years]
Maximum plasma concentration of the drug (Cmax) [Time frame: Up to approximately 8 years]

Eligibility criteria

Inclusion criteria

Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.

Exclusion criteria

Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.
Participants with any of the following:

LA-HNSCC that was resected before definitive cCRT
LA-HNSCC that was treated and is recurrent at the time of screening
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment