Study on the Effectiveness of Volrustomig in Women with High-Risk Locally Advanced Cervical Cancer After Chemoradiation Therapy

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called volrustomig in women with locally advanced cervical cancer. Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus that connects to the vagina. The study aims to determine if volrustomig is safe and effective for patients who have not shown disease progression after receiving a combination of chemotherapy and radiation therapy, known as chemoradiation.

Volrustomig, also known by its code name MEDI5752, is a type of medication called a monoclonal antibody. It is designed to target specific proteins in the body that may help the immune system fight cancer cells. In this study, volrustomig will be compared to a placebo to see if it can improve outcomes for patients. The study will also involve other medications such as Mycofit and Remsima, which are used in different contexts within the trial. Mycofit contains the active substance mycophenolate mofetil, and Remsima contains infliximab.

Participants in the trial will receive either volrustomig or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants over time to assess the progression of the cancer and overall survival rates. The goal is to see if volrustomig can help delay the progression of the disease and improve the quality of life for those affected by locally advanced cervical cancer. The trial is expected to continue until 2029, with recruitment starting in 2024.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and medical history related to cervical cancer.

A tumor sample is required to assess PD-L1 expression, which is a protein that may affect how the body responds to cancer treatment.

2 randomization

Participants are randomly assigned to receive either the study medication volrustomig or a placebo. This process ensures that the study results are unbiased.

3 treatment phase

The treatment involves receiving volrustomig or a placebo through an intravenous infusion. The frequency and duration of these infusions are determined by the study protocol.

Participants may also receive other medications such as mycophenolate mofetil in capsule form, which is taken orally, and infliximab, administered intravenously, depending on the study requirements.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the body’s response to the treatment. This includes imaging tests and blood tests.

Participants are evaluated for progression-free survival (PFS), which measures the time during and after treatment that the cancer does not worsen.

5 follow-up

After completing the treatment phase, participants enter a follow-up period where their health and any long-term effects of the treatment are monitored.

The study aims to determine the overall survival rate and the duration of response to the treatment.

Who Can Join the Study?

  • Must be female.
  • Must be able to provide signed informed consent, which means agreeing to participate after understanding the study details.
  • Must be at least 15 years old at the time of screening.
  • Must weigh more than 35 kg (about 77 pounds).
  • Must have a specific type of cervical cancer, which is confirmed by a test called a histological test. This includes certain stages of cervical cancer with lymph node involvement.
  • Initial tests to determine the stage of cancer must have been done no more than 42 days before starting the first treatment.
  • Must provide a sample of the tumor to check for PD-L1 expression, which is a specific protein that might be present in the cancer.
  • Must not have cancer that has worsened after a treatment called CCRT (a combination of chemotherapy and radiation therapy). If the disease is still present after this treatment, there should be no other available treatments that could cure it.
  • Must have a WHO/ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
  • Must have adequate organ and bone marrow function, meaning the organs and bone marrow are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who do not have locally advanced cervical cancer cannot participate. This means the cancer is in the cervix and may have spread to nearby tissues but not to distant parts of the body.
  • Only females can participate, so males are excluded.
  • Participants must have a specific protein called PD-L1 in their cancer cells. If this protein is not present, they cannot join the study.
  • Individuals who are considered part of a vulnerable population are excluded. This term refers to groups of people who might need special protection or care, such as children, pregnant women, or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oslo Universitetssykehus HF Oslo Norway
Hospital Clinico San Carlos Madrid Spain
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital Universitario 12 De Octubre Madrid Spain
St. Olavs Hospital HF Trondheim Norway
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Odense University Hospital Odense Denmark
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Alessandro Manzoni Hospital Lecco Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hyklmpasi Mszofyfe Svmimo Milan Italy
Utqhcyughp Mkxlbcm Cannso Hyouulcyhnurxsylv Hamburg Germany
Iarpvgcl Crdhug Dwjhocirghvllqxfe L'hospitalet De Llobregat Spain
Wigexdknaqk Waofobisycmddqbstiab Cfkztyh Odupkzidy I Taduxsjubcnrr Id Mlvgzolzbmk W Lrras Lodz Poland
Dkofkaaojhpw Cmfsmbx Oqjmkmhxw Phwunrvyyflz I Hseisaqzkir Wroclaw Poland
Aqmjhdu Ouzxkscbrwv Phb Lrtjwtzsdlvthulbv Cntkerubfa Catania Italy
Nxgadsum Imoblkxd Okoywsytx Iti Mxbks Skzaocbeiyzfwwdsxgzqvnnqdlqd Iowyqtnj Bnlbkifi Cracow Poland
Aksurmm Uogso Siotgblhn Lgacnx Dl Bilwagw Bologna Italy
Uonzetcnczpnpn Csmnxsd Kfwtdmnqp Gdansk Poland
Upsoeslwab Disel Sfpje Dc Raje Lb Sxnskffs Rome Italy
Kkhhqxno Eyamuuzlaitijvxbfuazoroq Hasayknqgueyktlbs Essen Germany
Heodcfzm Vgxr dzwfmyup Barcelona Spain
Hvwgdsfe Ubnrlohqcrqzu da A Cdnwtf A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
22.09.2023
Germany Germany
Recruiting
22.09.2023
Italy Italy
Recruiting
22.09.2023
Norway Norway
Recruiting
22.09.2023
Poland Poland
Recruiting
22.09.2023
Spain Spain
Recruiting
22.09.2023

Trial locations

Volrustomig is a medication being studied for its potential to help women with high-risk, locally advanced cervical cancer. This trial is looking at how well volrustomig works in patients who have not seen their cancer progress after receiving a combination of platinum-based chemotherapy and radiation therapy. The main goal is to see if volrustomig can improve progression-free survival, especially in patients with a specific protein expression called PD-L1.

Investigated diseases:

Locally Advanced Cervical Cancer – This is a stage of cervical cancer where the disease has spread beyond the cervix to nearby tissues but not to distant parts of the body. It often involves the pelvic wall or the lower part of the vagina. Symptoms may include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. As the cancer progresses, it may cause more severe symptoms and affect nearby organs. The progression can vary, with some cases advancing more rapidly than others. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:
2023-504374-38-00
Protocol code:
D7984C00002
NCT ID:
NCT06079671
Trial Phase:
Therapeutic confirmatory (Phase III)

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