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Monoclonal Antibodies

Volrustomig for Advanced Throat Cancer (eVOLVE-HNSCC Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 years
Awards & highlights

eVOLVE-HNSCC Trial Summary

This trial tests if a drug can help people with advanced throat cancer who have not improved after radiation/chemotherapy.

Who is the study for?
This trial is for adults with advanced head and neck squamous cell carcinoma that hasn't spread elsewhere. They should have completed treatment with chemo and radiation within the last 12 weeks without surgery, aiming to cure.Check my eligibility
What is being tested?
The study tests Volrustomig's effectiveness and safety against no further treatment after standard chemoradiotherapy in patients whose cancer remains but hasn't worsened or spread.See study design
What are the potential side effects?
While specific side effects of Volrustomig are not listed here, similar drugs often cause immune-related reactions, fatigue, skin issues, nausea, and potential infusion-related symptoms.

eVOLVE-HNSCC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is at an advanced stage and cannot be surgically removed.
Select...
My cancer is in the throat or mouth area and hasn't spread elsewhere.

eVOLVE-HNSCC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Secondary outcome measures
Area under the curve (AUC)
Landmark Overall Survival (OS) Rates
Landmark Progression-Free Survival (PFS) Rates
+10 more

eVOLVE-HNSCC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study ArmExperimental Treatment1 Intervention
Participants in this arm will receive volrustomig.
Group II: Observation ArmActive Control1 Intervention
Patients in this arm will undergo observation.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,611,558 Total Patients Enrolled
Robert Haddad, MDStudy ChairDana Farber Cancer Institute Massachusetts, USA
5 Previous Clinical Trials
60 Total Patients Enrolled
Lisa Licitra, MDStudy ChairFondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy
10 Previous Clinical Trials
565 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to participate in this research initiative?

"1145 individuals are eligible to join this trial, provided they have head and neck cancers and their age falls within the range of 18 and 130."

Answered by AI

Is the enrollment of octogenarians permissible in this experiment?

"As far as age restrictions go, this trial is open to individuals older than 18 and younger than 130 years old."

Answered by AI

How many research centers have implemented this clinical trial?

"This clinical trial is presently being offered in 61 distinct medical centres. Some of these sites are located in Palm Bay, Boston and Montreal, while there are numerous other locations to choose from as well. Prospective participants should select the nearest location to reduce time spent travelling during enrollment."

Answered by AI

What are the potential risks of participating in this particular research arm?

"Positive data from prior clinical trials, combined with multiple rounds of safety testing, has led our team at Power to rate Study Arm's safety as a 3 on the 1-3 scale."

Answered by AI

Are there any open recruitment opportunities for this research trial at present?

"Clinicaltrials.gov affirms that this medical study, which was initially put up on November 21st 2023, is no longer accruing patients. However, there are 2818 other trials currently recruiting participants at the moment."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
2023. "A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06129864.
All > Montreal > Spokane
~763 spots leftby Jan 2029
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