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

Sponsor
AstraZeneca (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06129864
Collaborator
(none)
1,145
Enrollment
72
Locations
2
Arms
78.9
Anticipated Duration (Months)
15.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1145 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Nov 21, 2023
Anticipated Primary Completion Date :
Jan 19, 2029
Anticipated Study Completion Date :
Jun 17, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Arm

Participants in this arm will receive volrustomig.

Drug: volrustomig
volrustomig
Other Names:
  • MEDI5752

    		•
    No Intervention: Observation Arm

    Patients in this arm will undergo observation.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors [Up to approximately 7 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 Outcome Measures

    1. Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population [Up to approximately 7 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 [Up to approximately 7 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 [Up to approximately 7 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 [Up to approximately 7 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 [Up to approximately 7 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) [Up to approximately 7 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 [Up to approximately 7 years]

      To investigate the immunogenicity of volrustomig.

    8. Participant-reported physical functioning [Up to approximately 7 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) [Up to approximately 7 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 [Up to approximately 7 years]

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

    11. Area under the curve (AUC) [Up to approximately 7 years]

      The concentration of MEDI5752 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) [Up to approximately 7 years]

      The concentration of MEDI5752 in serum will be determined (Cmax will be derived).

    13. The time taken to reach the maximum concentration (Tmax) [Up to approximately 7 years]

      The concentration of MEDI5752 in serum will be determined (Tmax will be derived).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts 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 within 12 weeks 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. Residual disease that needs further treatment with curative intent after definitive cCRT administration;

    2. LA-HNSCC that was resected before definitive cCRT

    3. 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.

    • Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) > 12 weeks (84 days) prior to randomization.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Prescott Valley Arizona United States 86314
    2 Research Site Springdale Arkansas United States 72762
    3 Research Site Los Angeles California United States 90095
    4 Research Site Santa Rosa California United States 95403
    5 Research Site Aurora Colorado United States 80045
    6 Research Site Lone Tree Colorado United States 80124
    7 Research Site Palm Bay Florida United States 32909
    8 Research Site Niles Illinois United States 60714
    9 Research Site Louisville Kentucky United States 40202
    10 Research Site Columbia Maryland United States 21044
    11 Research Site Boston Massachusetts United States 02215
    12 Research Site Saint Louis Missouri United States 63110
    13 Research Site Hackensack New Jersey United States 07601
    14 Research Site Portland Oregon United States 97213
    15 Research Site Flower Mound Texas United States 75028
    16 Research Site Houston Texas United States 77030
    17 Research Site Tyler Texas United States 75702
    18 Research Site Fairfax Virginia United States 22031
    19 Research Site Norfolk Virginia United States 23502
    20 Research Site Tacoma Washington United States 98415
    21 Research Site Edegem Belgium 2650
    22 Research Site Sao Paulo Brazil 01509-900
    23 Research Site Edmonton Alberta Canada T6G 1Z2
    24 Research Site London Ontario Canada N6A 5W9
    25 Research Site Toronto Ontario Canada M4N 3M5
    26 Research Site Montreal Quebec Canada H2X 0C1
    27 Research Site Montreal Quebec Canada H3T 1E2
    28 Research Site Montreal Quebec Canada H4A 3J1
    29 Research Site Lyon France 69373
    30 Research Site Villejuif France 94805
    31 Research Site Budapest Hungary 1122
    32 Research Site Budapest Hungary 1125
    33 Research Site Budapest Hungary 1145
    34 Research Site Győr Hungary 9024
    35 Research Site Kecskemét Hungary 6000
    36 Research Site Miskolc Hungary 3526
    37 Research Site Nyíregyháza Hungary 4400
    38 Research Site Pécs Hungary 7624
    39 Research Site Szekszárd Hungary 7100
    40 Research Site Koto-ku Japan 135-8550
    41 Research Site Sapporo-shi Japan 060-8638
    42 Research Site Goyang-si Korea, Republic of 410-769
    43 Research Site Gyeonggi-do Korea, Republic of 13620
    44 Research Site Incheon Korea, Republic of 21565
    45 Research Site Seoul Korea, Republic of 06351
    46 Research Site Seoul Korea, Republic of 5505
    47 Research Site Suwon Korea, Republic of 16247
    48 Research Site Badalona Spain 08916
    49 Research Site Barcelona Spain 08035
    50 Research Site Jaén Spain 23007
    51 Research Site Madrid Spain 28007
    52 Research Site Madrid Spain 28034
    53 Research Site Madrid Spain 28040
    54 Research Site Valencia Spain 46014
    55 Research Site Valencia Spain 46026
    56 Research Site Kaohsiung City Taiwan 833401
    57 Research Site Taichung Taiwan 404
    58 Research Site Taichung Taiwan 40705
    59 Research Site Taipei City Taiwan 11217
    60 Research Site Taipei Taiwan 10002
    61 Research Site Bangkok Thailand 10400
    62 Research Site Chaing Mai Thailand 50200
    63 Research Site Hat Yai Thailand 90110
    64 Research Site Ankara Turkey 06230
    65 Research Site Ankara Turkey 6200
    66 Research Site Antalya Turkey 07059
    67 Research Site Istanbul Turkey 34722
    68 Research Site Karsiyaka Turkey 35575
    69 Research Site Yenimahalle Turkey 06170
    70 Research Site London United Kingdom SE1 9RT
    71 Research Site London United Kingdom SW3 6JJ
    72 Research Site Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Chair: Robert Haddad, MD, Dana Farber Cancer Institute Massachusetts, USA
    • Study Chair: Lisa Licitra, MD, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT06129864
    Other Study ID Numbers:
    • D798EC00001
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 13, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck

    Study Results

    No Results Posted as of Nov 13, 2023