Study of Chemoradiotherapy With or Without Pembrolizumab for Patients With High-Risk, Locally Advanced Cervical Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of locally advanced cervical cancer, which is a type of cancer that occurs in the cervix and has spread to nearby tissues but not to distant parts of the body. The study is investigating the effects of a treatment called pembrolizumab, also known by its code name MK-3475, in combination with chemoradiotherapy. Chemoradiotherapy is a treatment that combines chemotherapy, which uses drugs to kill cancer cells, and radiation therapy, which uses high-energy rays to destroy cancer cells. The trial will compare this combination treatment to chemoradiotherapy with a placebo, which is a substance with no active drug.

The purpose of the study is to determine if adding pembrolizumab to chemoradiotherapy improves outcomes for patients with high-risk, locally advanced cervical cancer. Participants in the study will be randomly assigned to receive either the combination of pembrolizumab and chemoradiotherapy or chemoradiotherapy with a placebo. The study will monitor participants over a period to assess how well the cancer responds to the treatment and to evaluate overall survival rates.

Throughout the study, participants will receive their assigned treatments through intravenous infusion, which means the medication is given directly into a vein. The study aims to provide valuable information on whether pembrolizumab can enhance the effectiveness of standard chemoradiotherapy in treating this type of cervical cancer. Participants will be closely monitored by healthcare professionals to ensure their safety and to track the progress of their treatment.

1 enrollment and initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests to ensure adequate organ function.

A tissue sample from a tumor lesion is required for analysis. This is obtained through a biopsy.

2 treatment initiation

The treatment phase begins with the administration of chemoradiotherapy. This involves the use of cisplatin, which is given through an intravenous infusion. The specific dosage and frequency are determined by the healthcare provider based on individual needs.

Participants are randomly assigned to receive either pembrolizumab or a placebo. Pembrolizumab is administered as an intravenous infusion. The dosage is 25 mg/mL, and the frequency is determined by the study protocol.

3 ongoing treatment and monitoring

Throughout the treatment period, regular monitoring is conducted to assess the response to therapy. This includes imaging studies and laboratory tests to evaluate disease progression and overall health.

Participants are monitored for any side effects or adverse events. Adjustments to the treatment plan may be made based on these findings.

4 completion of treatment

Upon completion of the treatment regimen, a final assessment is conducted. This includes imaging studies and laboratory tests to evaluate the overall response to the treatment.

Participants are provided with follow-up care instructions and are monitored for any long-term effects of the treatment.

5 follow-up period

After the treatment phase, a follow-up period is initiated. This involves regular check-ups to monitor health status and detect any recurrence of the disease.

The follow-up period is designed to ensure ongoing support and management of any health issues that may arise post-treatment.

Who Can Join the Study?

The patient must have high-risk locally advanced cervical cancer. This means the cancer is in an advanced stage but has not spread to distant parts of the body.
The patient must have a specific type of cervical cancer confirmed by a lab test. These types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
The patient must not have received any major surgery, radiation, or drug treatment for cervical cancer before, and must not have had any immunotherapy (a treatment that helps the immune system fight cancer).
Female patients must not be pregnant or breastfeeding. They must agree to use very effective birth control during the study and for a certain time after the study ends. They also agree not to donate or store eggs for future use during this time.
Female patients must not breastfeed during the study and for a certain time after the study ends.
The patient must have a good performance status. This means they are fully active or can carry out light work, as assessed by a standard scale used by doctors.
The patient must provide a sample of their tumor from a biopsy, which is a procedure to remove a small piece of tissue for testing.
The patient must have a disease that can be evaluated by imaging tests, as determined by the study doctor or radiologist.
The patient must have adequate organ function. This means their organs, like the liver and kidneys, are working well enough to handle the treatment.

Who Cannot Join the Study?

Patients who are not female cannot participate in 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.
Patients who are part of a vulnerable population, such as those who cannot give consent or are at higher risk, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria
Universitaet Leipzig	Leipzig	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.	Athens	Greece
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
University Of Debrecen	Debrecen	Hungary
Ospedale San Raffaele S.r.l.	Milan	Italy
Alexandra Hospital	Athens	Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Karolinska University Hospital	Solna	Sweden
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
CHU Helora	La Louviere	Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Hospital Ostrava	Ostrava	Czechia
Utzfdesrrz Mxqfmqk Cuitgm Hycgrrabgarydazqe	Hamburg	Germany
Itztkx Ifxvnzjt Fvzuxxvehcubr Oqyguxmiplq	Rome	Italy
Cbsc Upwbxenorv Hztofsla	Cork	Ireland
Ghdxqls Haplwxfl Oz Psxzoq Asncb Alyfkjf	Patras	Greece
Ottwajalegxmnruuqwuxklbioy	Aalst	Belgium
Hsscl Bzarsg Hz	Bergen	Norway
Bzzdqjdb Uvelnpcrfi Hmfmgarw Cxwton	Besançon	France
Arehosv Odndnqzrimk Uaclsvojsabwb Cbimtofrvpeb Dkyzy Sceekr E Dimxn Slmikue Dx Teamzw	Turin	Italy
Kmvxuovf dde Uotfjczqwoqc Mrnmuqgl Alm	Munich	Germany
Accdfcr Ukryw Srahwyuou Lomplf Dv Bblmisg	Bologna	Italy
Uwmvnulhzm Ox Auyvfyc	Edegem	Belgium
Izywphey Cvvsbe Dmwbjywuniirslwhd	L'hospitalet De Llobregat	Spain
Hvenkwcv Vdks dajieknl	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	13.03.2020
Belgium	Not recruiting	13.03.2020
Czechia	Not recruiting	13.03.2020
France	Not recruiting	13.03.2020
Germany	Not recruiting	13.03.2020
Greece	Not recruiting	13.03.2020
Hungary	Not recruiting	13.03.2020
Ireland	Not recruiting	13.03.2020
Italy	Not recruiting	13.03.2020
Norway	Not recruiting	13.03.2020
Spain	Not recruiting	13.03.2020
Sweden	Not recruiting	13.03.2020

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the body’s immune system fight cancer cells. It is a type of immunotherapy that works by blocking a specific protein on cancer cells, allowing the immune system to better detect and destroy them. In this study, pembrolizumab is being tested in combination with chemoradiotherapy to see if it improves outcomes for patients with high-risk, locally advanced cervical cancer.

Chemoradiotherapy is a combination of chemotherapy and radiation therapy used to treat cancer. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while radiation therapy uses high-energy rays to target and destroy cancer cells. In this trial, chemoradiotherapy is being used as a standard treatment for cervical cancer, and its effectiveness is being compared with and without the addition of pembrolizumab.

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. The cancer may also affect nearby lymph nodes. Symptoms can include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. As the disease progresses, it may cause more severe symptoms and affect additional areas within the pelvis. The progression of the disease can vary, and it may require ongoing monitoring and evaluation.

Trial ID:

2022-501972-25-00

Protocol code:

MK-3475-A18

NCT ID:

NCT04221945

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Chemoradiotherapy With or Without Pembrolizumab for Patients With High-Risk, Locally Advanced Cervical Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?