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Virus Therapy

Volrustomig for Advanced Cervical Cancer (eVOLVECervical 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

Body weight > 35 kg

Histologically documented FIGO 2018 Stage IIIC to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with lymph node involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the study duration will be approximately 6 years.

Awards & highlights

eVOLVECervical Trial Summary

This trial studies if a drug can help treat advanced cervical cancer in women after chemotherapy.

Who is the study for?

This trial is for women with high-risk advanced cervical cancer (stages IIIC to IVA) who haven't worsened after platinum-based chemoradiotherapy. Participants must be at least 15 years old, weigh over 35 kg, and have a performance status indicating they can carry out daily activities. They should not have other active cancers or severe illnesses and cannot take immunosuppressive drugs recently.Check my eligibility

What is being tested?

The study tests Volrustomig against a placebo in women with certain stages of cervical cancer following initial treatment. It's a phase III trial, meaning it's fairly late in the testing process and focuses on effectiveness and safety. The trial randomly assigns participants to either the drug or placebo group without them knowing which one they're getting.See study design

What are the potential side effects?

While specific side effects are not listed here, similar trials may involve risks like immune reactions due to biologic therapy, potential worsening of pre-existing conditions, infusion-related reactions, fatigue, digestive issues or allergic responses.

eVOLVECervical Trial Eligibility Criteria

Inclusion Criteria

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

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My body weight is over 35 kg.

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My cervical cancer is at an advanced stage with lymph node involvement.

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My cancer did not worsen after combined chemotherapy and radiation, and I cannot undergo other curative treatments.

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My organs and bone marrow are working well.

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I can sign and understand the consent form.

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I am female.

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I can carry out all my usual activities without help.

eVOLVECervical Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the study duration will be approximately 6 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the study duration will be approximately 6 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the study duration will be approximately 6 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 PD-L1 expression based on the investigator assessment

Secondary outcome measures

Duration of Response (DoR) in participants with a CR or PR in the PD-L1 expression analysis set/FAS.

Incidence of adverse events of Volrustomig compared to placebo;

Objective Response Rate (ORR) in participants with PD-L1 expression/regardless of PD-L1 expression.

+12 more

eVOLVECervical Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VolrustomigExperimental Treatment1 Intervention

Volrustomig

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

European Network for Gynaecological Oncological Trial GroupsUNKNOWN

2 Previous Clinical Trials

1,970 Total Patients Enrolled

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,611,675 Total Patients Enrolled

Gynecologic Oncology Group FoundationUNKNOWN

1 Previous Clinical Trials

404 Total Patients Enrolled

Frequently Asked Questions

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

How many healthcare facilities are participating in this clinical investigation?

"As of now, 64 medical sites are welcoming trial participants. These locations include Shreveport, Curitiba and Sao Paulo along with 61 other cities; it is prudent to choose the nearest clinic in order to reduce travel demands when participating."

Answered by AI

Is there still capacity left for enrollees in this research project?

"Clinicaltrials.gov confirms that this experiment is presently enrolling participants, with the post date being September 22nd 2023 and its last update occurring on October 6th 2023."

Answered by AI

Has the Volrustomig drug been given regulatory clearance by the FDA?

"Our team at Power has assessed the safety of Volrustomig to be 3 due to its Phase 3 status, providing evidence for both efficacy and extensive security testing."

Answered by AI

How many patients is the research team recruiting for participation in this trial?

"Affirmative. Clinicaltrials.gov records reveal that this clinical experiment, which was initially made public on September 22nd 2023, is currently recruiting participants. About 1000 individuals need to be recruited from 64 different medical centers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)

2023. "Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079671.

All > Cervical Cancer > Tucson