Evaluating volrustomig for advanced head and neck cancer after chemoradiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Fountain Valley, California, United States Recruiting
• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  Santa Rosa, California, United States Recruiting
• Research Site
  Whittier, California, United States Recruiting

+256 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.