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

Phase 3RecruitingNCT06129864

AstraZeneca1,145 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,145

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

volrustomigDRUG

volrustomig

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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: 1. LA-HNSCC that was resected before definitive cCRT 2. 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.

Locations (305)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.

Time frame: Up to approximately 8 years

Secondary Outcomes

Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population

PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.

Time frame: Up to approximately 8 years

Landmark Progression-Free Survival (PFS) Rates

PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). These analyses will include participants with PD-L1 expressing tumors and all randomized participants.

Time frame: Up to approximately 8 years

Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

Overall survival (OS) is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants with PD-L1 expressing tumors.

Time frame: Up to approximately 8 years

Landmark Overall Survival (OS) Rates

OS is defined as the time from randomization until the date of death due to any cause. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants.

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research Site

Birmingham, Alabama, United States

RECRUITING

Research Site

Phoenix, Arizona, United States

RECRUITING

Research Site

Prescott Valley, Arizona, United States

SUSPENDED

Research Site

Springdale, Arkansas, United States

WITHDRAWN

Research Site

Fountain Valley, California, United States

RECRUITING

Research Site

Los Angeles, California, United States

SUSPENDED

Research Site

Orange, California, United States

WITHDRAWN

Research Site

San Francisco, California, United States

SUSPENDED

Research Site

Santa Rosa, California, United States

RECRUITING

Research Site

Whittier, California, United States

RECRUITING

...and 295 more locations

Time frame: Up to approximately 8 years

Overall Survival (OS) in the unresected LA-HNSCC ITT population

OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.

Time frame: Up to approximately 8 years

Progression Free Survival 2 (PFS2)

PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants.

Time frame: Up to approximately 8 years

Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum

To investigate the immunogenicity of volrustomig.

Time frame: Up to approximately 8 years

Participant-reported physical functioning

Change from baseline of physical functioning as measured by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v.20 - Physical Function 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. The analysis will include all randomized participants.

Time frame: Up to approximately 8 years

Participant-reported global health status (GHS)/quality of life (QoL)

Change from baseline of Global Health Status/Quality of Life subscale scores as measured by the European Organization for Research and Treatment of Cancer (EORTC) Item Library 172 are transformed to a 0-100 range; a higher score represents higher quality of life. The analysis will include all randomized participants.

Time frame: Up to approximately 8 years

Percentage of participants with Adverse Events

Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).

Time frame: Up to approximately 8 years

Area under the curve (AUC)

The concentration of Volrustomig in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

Time frame: Up to approximately 8 years

Maximum plasma concentration of the drug (Cmax)

The concentration of Volrustomig in serum will be determined (Cmax will be derived).

Time frame: Up to approximately 8 years

The time taken to reach the maximum concentration (Tmax)

The concentration of Volrustomig in serum will be determined (Tmax will be derived).

Time frame: Up to approximately 8 years