Een wereldwijde studie van Volrustomig (MEDI5752) voor deelnemers met niet-geresecteerd lokaal gevorderd plaveiselcelcarcinoom van hoofd en nek na definitieve gelijktijdige chemoradiotherapie (eVOLVE-HNSCC)
29 september 2026 bijgewerkt door: AstraZeneca
Een fase III, gerandomiseerde, open-label, multicenter, mondiale studie van Volrustomig (MEDI5752) als sequentiële therapie versus observatie bij deelnemers met niet-geresecteerd lokaal gevorderd plaveiselcelcarcinoom van hoofd en nek, die geen vooruitgang hebben geboekt na definitieve gelijktijdige chemoradiotherapie (eVOLVE- HNSCC)
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).
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
1145
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: AstraZeneca Clinical Study Information Center
- Telefoonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studie Locaties
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Charleroi, België, 6060
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Edegem, België, 2650
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Jette, België, 1090
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La Louvière, België, 7100
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Namur, België, 5000
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Barretos, Brazilië, 14784-400
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Florianópolis, Brazilië, 88034-000
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Fortaleza, Brazilië, 60336-045
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Ijuí, Brazilië, 98700-000
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Ipatinga, Brazilië, 35162-189
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Londrina, Brazilië, 86015-520
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Natal, Brazilië, 59075-740
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Porto Alegre, Brazilië, 91350200
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Ribeirão Preto, Brazilië, 14051-140
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Rio de Janeiro, Brazilië, 20231-050
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São Paulo, Brazilië, 04538-132
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Teresina, Brazilië, 64049-200
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Florence, Italië, 50139
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Modena, Italië, 41124
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Kobe, Japan, 650-0017
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Niigata, Japan, 951-8520
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Okayama, Japan, 700-8558
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Sapporo, Japan, 060-8638
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Sendai, Japan, 980-8574
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Shinjuku-ku, Japan, 160-0023
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Sunto-gun, Japan, 411-8777
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Metropolitan Borough of Wirral, Verenigd Koninkrijk, CH63 4JY
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Springdale, Arkansas, Verenigde Staten, 72762
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28204
- Werving
- Research Site
-
Winston-Salem, North Carolina, Verenigde Staten, 27157
- Werving
- Research Site
-
-
Ohio
-
Cleveland, Ohio, Verenigde Staten, 44106
- Ingetrokken
- Research Site
-
-
Oregon
-
Portland, Oregon, Verenigde Staten, 97213
- Ingetrokken
- Research Site
-
Portland, Oregon, Verenigde Staten, 97239
- Voltooid
- Research Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Ingetrokken
- Research Site
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15261
- Werving
- Research Site
-
York, Pennsylvania, Verenigde Staten, 17403
- Werving
- Research Site
-
-
South Dakota
-
Sioux Falls, South Dakota, Verenigde Staten, 57105
- Werving
- Research Site
-
Sioux Falls, South Dakota, Verenigde Staten, 57104
- Werving
- Research Site
-
-
Tennessee
-
Nashville, Tennessee, Verenigde Staten, 37212
- Werving
- Research Site
-
-
Texas
-
Austin, Texas, Verenigde Staten, 78745
- Werving
- Research Site
-
Dallas, Texas, Verenigde Staten, 75251
- Werving
- Research Site
-
Flower Mound, Texas, Verenigde Staten, 75028
- Ingetrokken
- Research Site
-
Houston, Texas, Verenigde Staten, 77030
- Ingetrokken
- Research Site
-
Odessa, Texas, Verenigde Staten, 79761
- Werving
- Research Site
-
Tyler, Texas, Verenigde Staten, 75702
- Ingetrokken
- Research Site
-
-
Utah
-
Salt Lake City, Utah, Verenigde Staten, 84112
- Werving
- Research Site
-
West Jordan, Utah, Verenigde Staten, 84088
- Werving
- Research Site
-
-
Virginia
-
Fairfax, Virginia, Verenigde Staten, 22031
- Werving
- Research Site
-
Norfolk, Virginia, Verenigde Staten, 23502
- Werving
- Research Site
-
Richmond, Virginia, Verenigde Staten, 23230
- Ingetrokken
- Research Site
-
-
Washington
-
Spokane, Washington, Verenigde Staten, 99204
- Ingetrokken
- Research Site
-
Tacoma, Washington, Verenigde Staten, 98405
- Ingetrokken
- Research Site
-
Tacoma, Washington, Verenigde Staten, 98415
- Actief, niet wervend
- Research Site
-
-
-
-
-
Da Nang, Vietnam, 550000
- Werving
- Research Site
-
Hanoi, Vietnam, 100000
- Werving
- Research Site
-
Ho Chi Minh City, Vietnam, 700000
- Werving
- Research Site
-
Huế, Vietnam, 530000
- Werving
- Research Site
-
Hà Nội, Vietnam, 100000
- Werving
- Research Site
-
Vinh, Vietnam, 460000
- Werving
- Research Site
-
-
-
-
-
Goyang-si, Zuid -Korea, 410-769
- Werving
- Research Site
-
Gyeonggi-do, Zuid -Korea, 13620
- Werving
- Research Site
-
Incheon, Zuid -Korea, 21565
- Werving
- Research Site
-
Seoul, Zuid -Korea, 06351
- Werving
- Research Site
-
Seoul, Zuid -Korea, 5505
- Werving
- Research Site
-
Seoul, Zuid -Korea, 3722
- Werving
- Research Site
-
Suwon, Zuid -Korea, 16247
- Werving
- Research Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 130 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Study Arm
Participants in this arm will receive volrustomig. |
volrustomig
Andere namen:
|
|
Geen tussenkomst: Observation Arm
Patients in this arm will undergo observation. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Tijdsspanne: 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. |
Up to approximately 8 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Landmark Progression-Free Survival (PFS) Rates
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Landmark Overall Survival (OS) Rates
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Overall Survival (OS) in the unresected LA-HNSCC ITT population
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Progression Free Survival 2 (PFS2)
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum
Tijdsspanne: Up to approximately 8 years
|
To investigate the immunogenicity of volrustomig. |
Up to approximately 8 years
|
|
Participant-reported physical functioning
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Participant-reported global health status (GHS)/quality of life (QoL)
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Percentage of participants with Adverse Events
Tijdsspanne: Up to approximately 8 years
|
Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE). |
Up to approximately 8 years
|
|
Area under the curve (AUC)
Tijdsspanne: 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. |
Up to approximately 8 years
|
|
Maximum plasma concentration of the drug (Cmax)
Tijdsspanne: Up to approximately 8 years
|
The concentration of Volrustomig in serum will be determined (Cmax will be derived). |
Up to approximately 8 years
|
|
The time taken to reach the maximum concentration (Tmax)
Tijdsspanne: Up to approximately 8 years
|
The concentration of Volrustomig in serum will be determined (Tmax will be derived). |
Up to approximately 8 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Robert Haddad, MD, Dana Farber Cancer Institute Massachusetts, USA
- Studie stoel: Lisa Licitra, MD, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 december 2023
Primaire voltooiing (Geschat)
17 april 2030
Studie voltooiing (Geschat)
28 februari 2031
Studieregistratiedata
Eerst ingediend
3 november 2023
Eerst ingediend dat voldeed aan de QC-criteria
10 november 2023
Eerst geplaatst (Werkelijk)
13 november 2023
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 september 2026
Laatste update ingediend die voldeed aan QC-criteria
29 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- D798EC00001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD-tijdsbestek voor delen
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD-toegangscriteria voor delen
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .