What side effects are associated with this type of intervention?

Common treatments for cervical cancer, such as platinum-based chemoradiation therapy (CCRT), often result in a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infection due to lowered white blood cell counts. Radiation therapy may lead to skin irritation, fatigue, diarrhea, and bladder irritation. Long-term side effects can include bowel and bladder dysfunction, sexual dysfunction, and lymphedema. Combining these treatments can amplify these side effects, making comprehensive management and supportive care essential.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of cervical cancer include a range of chemotherapeutic agents, targeted therapies, and immunotherapies. Notable approvals include platinum-based chemotherapies such as cisplatin, which is often used in combination with radiation therapy. Targeted therapies like bevacizumab, an angiogenesis inhibitor, have also been approved for use in combination with chemotherapy for persistent, recurrent, or metastatic cervical cancer. Additionally, pembrolizumab, an immune checkpoint inhibitor, has been approved for PD-L1 positive cervical cancer that has progressed during or after chemotherapy. These treatments reflect a broad approach to managing cervical cancer, focusing on disrupting cancer cell growth and enhancing the immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to Volrustomig for cervical cancer patients include: 1) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in advanced cervical cancer. 2) Tisotumab vedotin, an antibody-drug conjugate targeting tissue factor, which has demonstrated positive results in clinical trials for recurrent or metastatic cervical cancer. 3) Cemiplimab, another PD-1 inhibitor, which is being investigated for its potential in treating advanced cervical cancer. These therapies represent cutting-edge options that may offer new hope for patients in 2024.

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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

Must not have

Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula

Exposure to immune mediated therapy prior to the study for any indication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the study duration will be approximately 6 years.

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called Volrustomig to see if it can help women with advanced cervical cancer. The study focuses on those who haven't seen their cancer progress after initial treatment. Volrustomig might help stop or slow down the growth of cancer cells.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had a fistula connecting my bladder, colon, or rectum to my vagina.

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I have been treated with immunotherapy before.

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I have had an organ transplant.

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I have not had major surgery in the last 4 weeks or am still recovering from one.

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I do not have any uncontrolled illnesses.

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My cervical cancer is either small cell or mucinous adenocarcinoma type.

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I have had or will have a hysterectomy as part of my cervical cancer treatment.

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I have received treatments for cervical cancer other than CCRT.

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I have or had an autoimmune or inflammatory disorder.

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My cancer has spread to other parts of my body.

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

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 PD-L1 expression based on the investigator assessment

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VolrustomigExperimental Treatment1 Intervention

Volrustomig

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 17Eligibility 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

Common treatments for cervical cancer include chemotherapy, radiation therapy, and targeted molecular agents. Chemotherapy, often using platinum-based compounds like cisplatin, works by damaging the DNA of cancer cells, thereby inhibiting their ability to divide and grow. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors by causing DNA damage. Targeted molecular agents, which are being increasingly studied, aim to interfere with specific pathways critical for cancer cell survival and proliferation. Understanding these mechanisms is crucial for cervical cancer patients as it helps in selecting the most effective treatment plan, managing potential side effects, and improving overall outcomes. New treatments like Volrustomig, although not fully detailed, likely involve novel mechanisms that could offer additional benefits or reduced toxicity compared to traditional therapies.

Management of advanced primary urethral carcinomas.Novel approaches for concurrent irradiation in locally advanced cervical cancer: platinum combinations, non-platinum-containing regimens, and molecular targeted agents.