Clinical trial NCT06129864: A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 1145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
timeFrame: Up to approximately 7 years
Secondary outcomes:
measure: Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population
timeFrame: Up to approximately 7 years
measure: Landmark Progression-Free Survival (PFS) Rates
timeFrame: Up to approximately 7 years
measure: Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
timeFrame: Up to approximately 7 years
measure: Landmark Overall Survival (OS) Rates
timeFrame: Up to approximately 7 years
measure: Overall Survival (OS) in the unresected LA-HNSCC ITT population
timeFrame: Up to approximately 7 years
measure: Progression Free Survival 2 (PFS2)
timeFrame: Up to approximately 7 years
measure: Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum
timeFrame: Up to approximately 7 years
measure: Participant-reported physical functioning
timeFrame: Up to approximately 7 years
measure: Participant-reported global health status (GHS)/quality of life (QoL)
timeFrame: Up to approximately 7 years
measure: Percentage of participants with Adverse Events
timeFrame: Up to approximately 7 years
measure: Area under the curve (AUC)
timeFrame: Up to approximately 7 years
measure: Maximum plasma concentration of the drug (Cmax)
timeFrame: Up to approximately 7 years
measure: The time taken to reach the maximum concentration (Tmax)
timeFrame: Up to approximately 7 years
Other outcomes:
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country: Korea, Republic of
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city: Gyeonggi-do
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city: Seoul
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country: Korea, Republic of
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Poland
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country: Poland
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country: Poland
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city: Piotrków Trybunalski
country: Poland
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city: Tomaszów Mazowiecki
country: Poland
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city: Warszawa
country: Poland
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city: Badalona
country: Spain
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city: Barcelona
country: Spain
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city: Jaén
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city: Madrid
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city: Valencia
country: Spain
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city: València
country: Spain
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city: Changhua
country: Taiwan
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city: Kaohsiung City
country: Taiwan
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city: Taichung
country: Taiwan
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city: Taichung
country: Taiwan
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city: Taipei City
country: Taiwan
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city: Taipei
country: Taiwan
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city: Bangkok
country: Thailand
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city: Bangkok
country: Thailand
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city: Chaing Mai
country: Thailand
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city: Hat Yai
country: Thailand
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city: Khon Kaen
country: Thailand
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city: Ankara
country: Turkey
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city: Ankara
country: Turkey
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city: Antalya
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
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city: Karsiyaka
country: Turkey
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city: Yenimahalle
country: Turkey
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city: Aberdeen
country: United Kingdom
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city: Cambridge
country: United Kingdom
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city: Hampshire
country: United Kingdom
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city: Leeds
country: United Kingdom
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city: London
country: United Kingdom
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city: London
country: United Kingdom
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city: London
country: United Kingdom
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city: Manchester
country: United Kingdom
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city: Northwood
country: United Kingdom
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city: Sutton
country: United Kingdom
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city: Taunton
country: United Kingdom
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city: Wirral
country: United Kingdom
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city: Hanoi
country: Vietnam
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city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Vinh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Dana Farber Cancer Institute Massachusetts, USA
name: Robert Haddad, MD
role: STUDY_CHAIR
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy
name: Lisa Licitra, MD
role: STUDY_CHAIR
References: