Study on Atezolizumab, Bevacizumab, and Chemotherapy for Patients with Advanced Cervical Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called cervical cancer, specifically when it has spread to other parts of the body (metastatic), is persistent, or has returned after treatment. The study is testing a combination of treatments to see if they can help patients live longer without the cancer getting worse. The treatments being tested include a chemotherapy drug called paclitaxel, combined with another drug called bevacizumab (also known as Avastin), and a third drug called atezolizumab (also known by its code name RO5541267 or Tecentriq). These drugs are given as a solution through a vein, which is known as an infusion.

The purpose of the study is to find out if adding atezolizumab to the usual treatment of chemotherapy and bevacizumab can improve the time patients live without their cancer getting worse and if it can help them live longer overall. Participants in the study will be randomly assigned to receive either the combination of paclitaxel, bevacizumab, and atezolizumab or just paclitaxel and bevacizumab. The study will last for a period of time, and participants will receive regular infusions of the drugs. Some participants may receive a placebo instead of atezolizumab to compare the effects of the treatment.

Throughout the study, participants will be monitored closely by healthcare professionals to track their progress and any side effects they may experience. The study aims to provide valuable information on whether the addition of atezolizumab can offer better outcomes for patients with metastatic, persistent, or recurrent cervical cancer. This research could potentially lead to new treatment options for this type of cancer in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive a combination of atezolizumab, bevacizumab, and chemotherapy, or a combination of bevacizumab and chemotherapy without atezolizumab.

2 treatment administration

If you are in the group receiving atezolizumab, you will be given a dose of 1,200 mg. This medication is administered as a solution for infusion, which means it is given directly into your vein through an intravenous (IV) line.

You will also receive bevacizumab at a dose of 25 mg/ml, also as a solution for infusion. The chemotherapy drugs, which may include cisplatin or carboplatin and paclitaxel, will be administered according to the specific schedule set by the study team.

The frequency and duration of these treatments will be explained to you by the study team, and they will monitor your progress throughout the trial.

3 monitoring and follow-up

Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess the progression of your condition.

The study team will also monitor for any side effects or adverse reactions to the medications. It is important to report any new symptoms or concerns to the study team promptly.

4 end of treatment

At the end of the treatment period, you will have a final evaluation to assess the overall impact of the treatment on your condition.

The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who Can Join the Study?

Must be a female patient.
Must be 18 years of age or older.
Must have a diagnosis of metastatic (stage IVB), persistent, or recurrent cervical cancer that cannot be treated with surgery or radiation for a cure.
Must have adequate organ function:
- Hemoglobin (a protein in red blood cells) level of at least 9 g/dL.
- ANC (a type of white blood cell) of at least 1.5 x 10⁹/L.
- Lymphocyte count (another type of white blood cell) of at least 0.5 x 10⁹/L.
- Platelet count (cells that help with blood clotting) of at least 100 x 10⁹/L.
Must have adequate liver function:
- Serum albumin (a protein made by the liver) of at least 2.5 g/dL.
- Total serum bilirubin (a substance made by the liver) of no more than 1.5 times the upper limit of normal (ULN).
- AST and ALT (liver enzymes) of no more than 2.5 times ULN, or no more than 5 times ULN if the liver is affected by the tumor.
Must have adequate kidney function:
- Serum creatinine (a waste product filtered by the kidneys) of less than 1.5 times ULN.
- Urine dipstick for proteinuria (protein in urine) of less than 2+. If 2+ proteinuria is found, a 24-hour urine collection must show less than 1 g of protein in 24 hours or a urine protein/creatinine (UPC) ratio of 1.0 or less.
Must have adequate blood clotting:
- INR (a measure of blood clotting) of 1.5 or less, or between 2 and 3 if on a stable dose of warfarin (a blood thinner).
- PTT (another measure of blood clotting) of less than 1.5 times ULN.
Must have negative test results for Hepatitis.
Must have recovered from side effects of previous treatments to less than grade 2, except for hair loss.
Must be postmenopausal, surgically sterile, or have a negative pregnancy test and agree to use effective birth control during the study and for a period after the last dose of study treatment.
Must provide signed informed consent before any study-specific procedures.
Must be able to comply with the study protocol, as judged by the investigator.
Must have a GOG/ECOG performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have a life expectancy of at least 3 months.
Must have measurable disease by RECIST v1.1 criteria, which means having at least one “target lesion” to assess response to treatment. If the only target lesion is in a previously treated area, a biopsy is needed to confirm cancer.
Must provide a tumor specimen at study entry, which can be an old biopsy or a new one from a non-treated area within 3 months of starting the study.
Must not have had prior systemic anti-cancer therapy for metastatic or recurrent disease. Previous chemo-radiotherapy with curative intent must have been completed at least 3 months before joining the study. Palliative radiation therapy for symptoms like pain or bleeding is allowed if it was done 6 weeks before joining and does not affect measurable disease.

Who Cannot Join the Study?

Patients with other types of cancer besides the specific type being studied cannot participate.
Patients who have had a different cancer in the past, unless it was treated and has not come back for at least 5 years, cannot participate.
Patients who have an active infection that requires treatment with antibiotics cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a serious heart condition, such as a recent heart attack or heart failure, cannot participate.
Patients who have a known allergy to any of the study drugs cannot participate.
Patients who have a condition that affects their immune system, such as HIV, cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a major surgery within the last 4 weeks cannot participate.
Patients who have a history of bleeding disorders cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Centre Antoine Lacassagne	Nice	France
Ospedale Vito Fazzi Lecce	Lecce	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hochtaunus-Kliniken gGmbH	Bad Homburg	Germany
Mammazentrum Hamburg MVZ GbR	Hamburg	Germany
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Karolinska University Hospital	Solna	Sweden
Saarland University Hospital	Homburg	Germany
Universita’ Di Pisa	Pisa	Italy
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hopital Prive Des Cotes D’armor	Plerin	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Hopital Beaujon	Clichy	France
Servei De Salut De Les Illes Balears	Palma	Spain
Polyclinique Courlancy-Bezannes	Reims	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
L’Hopital Prive Du Confluent	Nantes	France
Igjitdyj Rbnxdkve Ds Csvdcd Dj Mahlwesajrr	Montpellier	France
Coviah Lxkw Bebphh	Lyon	France
Ubbcrsplfh Mrpsocn Cnroxc Hfkufizhrzhtzvpdx	Hamburg	Germany
Izzflmtx Cselhz Ddpkmjkgngropzlwh	L'hospitalet De Llobregat	Spain
Lobtsxwvgg Ukndwiswwfc	Linkoping	Sweden
Itcyyseu Rjaqkgamy Pbl Lm Swkubs Dlc Tmqkie Desn Athtdvy Iawz Syevsp	Meldola	Italy
Urqknna Urmugxqhcl Hrjdytbv	Uppsala	Sweden
Hzdcr Becouk Hf	Bergen	Norway
Bypnzmlw Uufybvnpjk Hbiokikz Cijfmd	Besançon	France
Aywsiew Ocdrhnkwbix Ugenyirpxkqar Corkdiwcmgkb Dnfwf Snbfcc E Ddpay Soxenox Dw Tlmpdg	Turin	Italy
Hocyxuqg Ubfruhbqifyir Dokxyfjb	Donostia / San Sebastian	Spain
Kwtyagag dcu Uiaqwlfpugvf Mwzonbta Ass	Munich	Germany
Fuzbiuyrn Pqnl Lc Iijviycfriugb Bjtxwmglc Djo Hfhxwgur Uqllrsfkyxcav Ld Pex	Madrid	Spain
Cdx Ctojg Rdsgovoxanh	Lyon	France
Huiflosh Vxfj dmiqlpjm	Barcelona	Spain
Cysqbu Oliun Lqzukoc	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	25.09.2018
Germany	Not recruiting	25.09.2018
Italy	Not recruiting	25.09.2018
Norway	Not recruiting	25.09.2018
Spain	Not recruiting	25.09.2018
Sweden	Not recruiting	25.09.2018

Trial locations

Investigated drugs:

Platinum Chemotherapy is a type of cancer treatment that uses drugs containing the metal platinum. These drugs work by damaging the DNA of cancer cells, which stops them from growing and dividing. In this trial, platinum chemotherapy is used to help treat cervical cancer that has spread, come back, or is not responding to other treatments.

Paclitaxel is a chemotherapy drug that helps stop cancer cells from growing by interfering with their ability to divide. It is often used in combination with other cancer treatments to improve their effectiveness. In this trial, paclitaxel is combined with other medications to treat advanced cervical cancer.

Bevacizumab is a medication that works by blocking a protein called VEGF, which helps tumors form new blood vessels. By stopping this process, bevacizumab can slow the growth of tumors and help shrink them. It is used in this trial to enhance the effects of chemotherapy in treating cervical cancer.

Atezolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this trial, atezolizumab is added to the treatment plan to see if it can improve the outcomes for patients with advanced cervical cancer.

Investigated diseases:

Cervix carcinoma

Metastatic (stage IVB), Persistent, or Recurrent Carcinoma of the Cervix – This disease refers to a type of cancer that originates in the cervix and has spread to other parts of the body, or continues to exist despite treatment, or has returned after a period of remission. In its metastatic stage, the cancer cells have traveled beyond the cervix to distant organs, which can include the lungs, liver, or bones. Persistent carcinoma indicates that the cancer remains in the body even after initial treatment efforts. Recurrent carcinoma means the cancer has returned after being undetectable for a time. The progression of this disease involves the growth and spread of cancerous cells, which can lead to various symptoms depending on the organs affected. The disease can cause symptoms such as abnormal bleeding, pelvic pain, and changes in bladder or bowel habits as it advances.

Trial ID:

2024-514179-17-00

Protocol code:

BEATcc

NCT ID:

NCT03556839

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Atezolizumab, Bevacizumab, and Chemotherapy for Patients with Advanced Cervical Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?