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New treatment option for Locally Advanced Cervical Cancer
Official title Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
ClinicalTrials.gov ID: NCT06079671
What this study is testing
What is Volrustomig?
Volrustomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older, women only
You may be able to join if
- For inclusion in the study, patients should fulfill the following criteria:
- Female.
- Aged at least 15 years at the time of screening. Note: Participants \< 18 years of age: physical changes should be aligned with Tanner Stage III.
- Body weight \> 35 kg.
- Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with...
You likely can't join if
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
- Evidence of metastatic disease.
- Intent to administer a fertility-sparing treatment regimen.
- History of organ transplant or allogenic stem cell transplant.
- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
See the full eligibility criteria
- For inclusion in the study, patients should fulfill the following criteria:
- Female.
- Aged at least 15 years at the time of screening. Note: Participants \< 18 years of age: physical changes should be aligned with Tanner Stage III.
- Body weight \> 35 kg.
- Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.
- Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.
- Provision of FFPE tumor sample to assess the PD-L1 expression.
- Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
- WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Capable of providing signed informed consent.
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
- Evidence of metastatic disease.
- Intent to administer a fertility-sparing treatment regimen.
- History of organ transplant or allogenic stem cell transplant.
- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin...
- Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
- Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
- History of anaphylaxis to any biologic therapy or vaccine.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids...
- Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
- Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
- Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
- Exposure to immune mediated therapy prior to the study for any indication.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
- Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- West Hollywood, California, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Savannah, Georgia, United States
- Melrose Park, Illinois, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
- New York, New York, United States
- Syracuse, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Eugene, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
+ 141 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; West Hollywood, California, United States and 155 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.