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Evaluating volrustomig for advanced head and neck cancer after chemoradiotherapy

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)

Phase 3 Interventional AstraZeneca · NCT06129864

This study is testing if a new treatment called volrustomig can help people with advanced head and neck cancer who haven't seen their disease get worse after previous treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1145 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations305 sites (Birmingham, Alabama and 304 other locations)
Trial IDNCT06129864 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of volrustomig in patients with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after definitive concurrent chemoradiotherapy. Participants will be randomized to receive either volrustomig or observation to determine the treatment's effectiveness. The study focuses on patients with specific stages of LA-HNSCC, ensuring they have completed prior treatment within a defined timeframe. The goal is to provide a potential therapeutic option for this challenging cancer population.

Who should consider this trial

Good fit: Ideal candidates are individuals with unresected Stage III, IVA, or IVB head and neck squamous cell carcinoma who have completed chemoradiotherapy within the last 12 weeks.

Not a fit: Patients with head and neck cancers of non-specified primary locations or those with multiple primary tumors will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients with advanced head and neck cancer who have not progressed after initial therapy.

How similar studies have performed: Other studies have explored similar therapeutic approaches in advanced head and neck cancers, but the specific use of volrustomig in this context is novel.

Eligibility criteria

Show full inclusion / exclusion 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 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. LA-HNSCC that was resected before definitive cCRT
  2. 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.

Where this trial is running

Birmingham, Alabama and 304 other locations

+255 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced Head and Neck Squamous Cell Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.