A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women with High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

Enrolling By Invitation
15 years - 100 years
Female
Phase 3

Brief description of study

What is the purpose of this study?
This study aims to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIC to IVA cervical cancer with lymph node involvement) who have not progressed following platinum-based CCRT.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632</div>

Detailed description of study

What will happen during the study?
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: cervical adenocarcinoma, cervical squamous carcinoma, cervical adenosquamous carcinoma
  • Age: 15 years - 100 years
  • Gender: Female

Inclusion Criteria:
  1. Female.
  2. Aged at least 15 years at the time of screening.
  3. Body weight > 35 kg.
  4. Histologically documented FIGO 2018 Stage IIIC to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with lymph node involvement.
  5. Initial staging procedures performed no more than 42 days prior to the first dose of CCRT.
  6. Provision of tumor sample to assess the PD-L1 expression.
  7. Musthave progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
  8. WHO/ECOG performance status of 0 or 1.
  9. Adequate organ and bone marrow function.
  10. Capable of providing signed informed consent.
Exclusion Criteria:
  1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
  2. Evidence of metastatic disease.
  3. Intent to administer a fertility-sparing treatment regimen.
  4. History of organ transplant.
  5. Active or prior documented autoimmune or inflammatory disorders.
  6. Uncontrolled intercurrent illness.
  7. Historyher 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 cancer or lentigo maligna, or carcinoma in situ without evidence of disease.
  8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
  9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
  10. History of anaphylaxis to any biologic therapy or vaccine.
  11. Currentuse 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, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control).
  12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
  13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
  14. Majorurgical procedures within 4 weeks prior to the first dose of the studyvention or still recovering from prior surgery.
  15. Exposure to immune mediated therapy prior to the study for any indication.
  16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
  17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Updated on 17 Dec 2024. Study ID: CTO-GOG-3092, 22919
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