NCT06129864
Recruiting
Phase 3
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)
Interventionsvolrustomig
Drugsvolrustomig
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 1,145
- Locations
- 305
- Primary Endpoint
- Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 130 Years (Adult, Older Adult)
- Sex
- 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 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.
Arms & Interventions
Study Arm
Experimental
Participants in this arm will receive volrustomig.
Intervention: volrustomig (Drug)
Observation Arm
No Intervention
Patients in this arm will undergo observation.
Outcomes
Primary Outcomes
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Time Frame: 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
- Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors(Up to approximately 8 years)
- Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population(Up to approximately 8 years)
- Landmark Progression-Free Survival (PFS) Rates(Up to approximately 8 years)
- Landmark Overall Survival (OS) Rates(Up to approximately 8 years)
- Overall Survival (OS) in the unresected LA-HNSCC ITT population(Up to approximately 8 years)
- Progression Free Survival 2 (PFS2)(Up to approximately 8 years)
- Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum(Up to approximately 8 years)
- Participant-reported physical functioning(Up to approximately 8 years)
- Participant-reported global health status (GHS)/quality of life (QoL)(Up to approximately 8 years)
- Percentage of participants with Adverse Events(Up to approximately 8 years)
- Area under the curve (AUC)(Up to approximately 8 years)
- Maximum plasma concentration of the drug (Cmax)(Up to approximately 8 years)
- The time taken to reach the maximum concentration (Tmax)(Up to approximately 8 years)
Investigators
Study Sites (305)
Loading locations...
Similar Trials
Recruiting
Phase 3
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLCNon-squamous Non-small Cell Lung CancerNCT06627647AstraZeneca878
Recruiting
Phase 2
Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid TumorsSub-study 1 Cervical Cancer (Volrustomig Monotherapy)Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy)Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)Sub-study 4 Esophageal Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)Sub-study 5 Unresectable Pleural Mesothelioma (Volrustomig Monotherapy)NCT06535607AstraZeneca257
Completed
Phase 3
Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia AHemophilia ANCT04323098BioMarin Pharmaceutical22
Recruiting
Phase 3
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.Ph+ ALLNCT06051409Ascentage Pharma Group Inc.350
Active, not recruiting
Phase 3
Clinical study in order to compare the effectiveness and safety of two different treatments in patients with newly diagnosed primary immune thrombocytopenia2024-514147-28-00Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla86