> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-global-study-of-volrustomig-medi5752-for-participants-with-2bb7b094-835f-4351-ad81-a510ac4f6f92 > Record changed: 2026-10-13 # A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy NCT06129864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) Participants 1,145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) Start date 2023-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) Number of sites 306 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Acronym** eVOLVE-HNSCC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Short title** A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Dates **Completion date** 2031-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **First posted** 2023-11-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Primary completion date** 2030-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Start date** 2023-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Size and sites **Participants** 1,145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Planned participants** 1,145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Number of sites** 306 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Identifiers **Registry ID** NCT06129864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **ClinicalTrials.gov ID** NCT06129864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Outcomes ### Primary outcomes 1. Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors Timeframe: Up to approximately 8 years 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. ### Secondary outcomes 1. Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population Timeframe: Up to approximately 8 years 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. 2. Landmark Progression-Free Survival (PFS) Rates Timeframe: Up to approximately 8 years 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. 3. Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors Timeframe: Up to approximately 8 years 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. 4. Landmark Overall Survival (OS) Rates Timeframe: Up to approximately 8 years 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. 5. Overall Survival (OS) in the unresected LA-HNSCC ITT population Timeframe: Up to approximately 8 years OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants. 6. Progression Free Survival 2 (PFS2) Timeframe: Up to approximately 8 years 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. 7. Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum Timeframe: Up to approximately 8 years To investigate the immunogenicity of volrustomig. 8. Participant-reported physical functioning Timeframe: Up to approximately 8 years 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. 9. Participant-reported global health status (GHS)/quality of life (QoL) Timeframe: Up to approximately 8 years 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. 10. Percentage of participants with Adverse Events Timeframe: Up to approximately 8 years Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE). 11. Area under the curve (AUC) Timeframe: Up to approximately 8 years 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. 12. Maximum plasma concentration of the drug (Cmax) Timeframe: Up to approximately 8 years The concentration of Volrustomig in serum will be determined (Cmax will be derived). 13. The time taken to reach the maximum concentration (Tmax) Timeframe: Up to approximately 8 years The concentration of Volrustomig in serum will be determined (Tmax will be derived). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 130 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Sites - Research SiteBirmingham, United StatesRecruiting - Research SitePhoenix, United StatesRecruiting - Research SitePrescott Valley, United StatesActive, not recruiting - Research SiteSpringdale, United StatesWithdrawn - Research SiteFountain Valley, United StatesRecruiting - Research SiteLos Angeles, United StatesRecruiting - Research SiteOrange, United StatesWithdrawn - Research SiteSan Francisco, United StatesRecruiting - Research SiteSanta Rosa, United StatesRecruiting - Research SiteWhittier, United StatesRecruiting - Research SiteAurora, United StatesRecruiting - Research SiteColorado Springs, United StatesRecruiting - Research SiteLone Tree, United StatesRecruiting - Research SiteWashington D.C., United StatesRecruiting - Research SiteFort Myers, United StatesRecruiting - Research SiteGainesville, United StatesWithdrawn - Research SiteMiami, United StatesWithdrawn - Research SitePalm Bay, United StatesRecruiting - Research SiteWest Palm Beach, United StatesRecruiting - Research SiteNiles, United StatesRecruiting - Research SiteDes Moines, United StatesRecruiting - Research SiteKansas City, United StatesCompleted - Research SiteLouisville, United StatesRecruiting - Research SiteBaton Rouge, United StatesRecruiting - Research SiteShreveport, United StatesWithdrawn And 281 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06129864) ## Related records ### Drugs (1) - [Volrustomig](https://trialight.com/data/asset/volrustomig-e9a9b6cf-0106-440a-a7d9-8917b1abbccf.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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