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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 regarding the demonstration os in participants, 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 belowSelect...
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.
Select...
I can sign and understand the consent form.
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I am female.
Select...
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:Select...
I have or had a fistula connecting my bladder, colon, or rectum to my vagina.
Select...
I have been treated with immunotherapy before.
Select...
I have had an organ transplant.
Select...
I have not had major surgery in the last 4 weeks or am still recovering from one.
Select...
I do not have any uncontrolled illnesses.
Select...
My cervical cancer is either small cell or mucinous adenocarcinoma type.
Select...
I have had or will have a hysterectomy as part of my cervical cancer treatment.
Select...
I have received treatments for cervical cancer other than CCRT.
Select...
I have or had an autoimmune or inflammatory disorder.
Select...
My cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ regarding the demonstration os in participants, the study duration will be approximately 6 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~regarding the demonstration os in participants, the study duration will be approximately 6 years.
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) based on the investigator assessment in all randomized participants (FAS)
Secondary study objectives
Duration of Response (DoR) in all randomized participants.
Incidence of adverse events of Volrustomig compared to placebo.
Objective Response Rate (ORR) in all randomized participants.
+10 moreAwards & 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
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.
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.
Find a Location
Who is running the clinical trial?
European Network for Gynaecological Oncological Trial GroupsUNKNOWN
3 Previous Clinical Trials
2,031 Total Patients Enrolled
AstraZenecaLead Sponsor
4,418 Previous Clinical Trials
289,124,574 Total Patients Enrolled
Gynecologic Oncology Group FoundationUNKNOWN
2 Previous Clinical Trials
471 Total Patients Enrolled