What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, particularly immunotherapies and targeted therapies similar to Volrustomig, often have side effects such as fatigue, skin reactions, diarrhea, and endocrine disorders. Targeted therapies like cetuximab can also cause hypomagnesemia and infusion-related reactions. Additionally, these treatments may lead to general side effects including nausea and an increased risk of infections.

What prior FDA approvals exist?

FDA-approved treatments for head and neck cancers include several immunotherapies and targeted therapies. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors that target PD-1, enhancing the immune response against cancer cells. Cetuximab (Erbitux) is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), used in combination with chemotherapy or as a single agent. These treatments aim to improve overall survival and progression-free survival in patients with recurrent or metastatic head and neck squamous cell carcinoma.

What other types of research exist?

Promising novel alternatives to Volrustomig for Head and Neck Cancers in 2024 include: 1) Pembrolizumab and Nivolumab, both PD-1 inhibitors that have shown efficacy in head and neck squamous cell carcinoma (HNSCC). 2) Atezolizumab, a PD-L1 inhibitor, which is being investigated in combination with chemotherapy. 3) Cetuximab, an EGFR inhibitor, which can be used in combination with radiation or chemotherapy. 4) Durvalumab, another PD-L1 inhibitor, which is being studied in combination with other agents. These therapies aim to enhance the immune response or target specific pathways involved in cancer progression.

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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing volrustomig, a medication, in patients with a specific type of head and neck cancer that hasn't worsened after standard treatment. The goal is to see if volrustomig can help stop the cancer from growing.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is at an advanced stage and cannot be surgically removed.

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My cancer is in the throat or mouth area and hasn't spread elsewhere.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 7 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

Secondary study objectives

Area under the curve (AUC)

Landmark Overall Survival (OS) Rates

Landmark Progression-Free Survival (PFS) Rates

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Cancers include immunotherapy and targeted therapy. Immunotherapy, such as checkpoint inhibitors, enhances the immune system's ability to recognize and destroy cancer cells. Targeted therapies focus on specific molecular pathways that are essential for cancer cell growth and survival, such as the EGFR pathway. These treatments are particularly important for Head and Neck Cancer patients as they provide more personalized and potentially more effective options, especially for those who have not responded well to traditional treatments like chemotherapy and radiation.

Locoregional immunotherapy in cancer patients: review of clinical studies.