Treatment for women with high-risk locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial investigates the efficacy and safety of volrustomig in women diagnosed with high-risk locally advanced cervical cancer who have not shown disease progression after platinum-based chemoradiotherapy. Participants will be randomly assigned to receive either volrustomig or a placebo in a double-blind manner. The study aims to determine if volrustomig can improve outcomes for these patients compared to standard treatment options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

1. Female.
2. 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.
3. Body weight \> 35 kg.
4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.
5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.
6. Provision of FFPE tumor sample to assess the PD-L1 expression.
7. Must not have 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; duration of life expectancy of ≥ 12 weeks.
9. Adequate organ and bone marrow function.
10. Capable of providing signed informed consent.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

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 or allogenic stem cell transplant.
5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
6. Uncontrolled intercurrent illness.
7. 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 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. 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, 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); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days.
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. Major surgical procedures within 4 weeks prior to the first dose of the study intervention 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.

Where it's running

• Research Site
  Barretos, Brazil Recruiting
• Research Site
  Belo Horizonte, Brazil Recruiting
• Research Site
  Curitiba, Brazil Recruiting
• Research Site
  Fortaleza, Brazil Recruiting
• Research Site
  Fortaleza, Brazil Recruiting
• Research Site
  Ijuí, Brazil Recruiting

+155 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Iparomlimab/Tuvonralimab with nab-paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer

  This trial tests whether adding Iparomlimab/Tuvonralimab to nab-paclitaxel and cisplatin before surgery can shrink locally advanced cervical cancer and safely be given to adult women.

  Recruiting Phase 2 Xijing Hospital · Xi'an, Shaanxi · NCT07876154

• Vitamin D Status and Outcomes in Locally Advanced Cervical Cancer treated with chemoradiotherapy

  This study tests whether pretreatment vitamin D levels can predict how well women with locally advanced cervical cancer respond to standard chemoradiotherapy.

  Recruiting University of Kragujevac · Kragujevac, Šumadija · NCT07743918

• Patient-tailored 3D-printed ARCHITECT applicator for cervical cancer brachytherapy

  We’re testing a 3D-printed, one-time use ARCHITECT applicator to see if it safely helps deliver brachytherapy for locally advanced cervical cancer.

  Recruiting Erasmus Medical Center · Rotterdam · NCT07435987

• Nanocrystalline megestrol acetate with chemoradiation for locally advanced cervical cancer

  This Phase 1 trial tests whether taking nanocrystalline megestrol acetate by mouth can prevent or reduce weight and muscle loss in adults with locally advanced cervical cancer who are receiving concurrent chemoradiotherapy.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan · NCT07338487

• Cadonilimab plus cisplatin given before surgery for locally advanced cervical cancer

  This study will test whether giving cadonilimab together with cisplatin before surgery helps people with resectable, locally advanced cervical cancer.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07104149

• Pre-surgery iparomlimab and tuvonralimab with chemotherapy for locally advanced cervical cancer

  This phase 2 trial tests whether giving iparomlimab and tuvonralimab with chemotherapy before surgery helps people with locally advanced cervical cancer shrink their tumors and improve outcomes.

  Recruiting Phase 2 Fujian Cancer Hospital · Fuzhou, Fujian · NCT07055399

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.