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)

JRCT ID: jRCT2041230127

Registered date:11/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally Advanced Head and Neck Squamous Cell Carcinoma
• Date of first enrollment: 11/01/2024
• Target sample size: 96
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Finland,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Italy,Japan,Malaysia,Japan,Netherlands,Japan,Norway,Japan,Philippines,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,United States of America,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

volrustomig Arm

the volrustomig arm will receive volrustomig IV every 3 weeks for up to 12 months, or 18 cycles, or until RECIST 1.1-defined radiological PD confirmed by investigator assessment.

Outcome(s)

Primary Outcome

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors [ Time Frame: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06129864