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Monoclonal Antibodies
Chemotherapy + Bevacizumab + Atezolizumab for Cervical Cancer (BEATcc Trial)
Phase 3
Waitlist Available
Led By Ana Oaknin, MD PhD
Research Sponsored by Grupo Español de Investigación en Cáncer de Ovario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients must be ≥18 years of age.
Adequate organ function (Hemoglobin ≥9 g/dL, ANC ≥1.5 × 109/L, Lymphocyte count ≥0.5 × 109/L, Platelet count ≥100 x 109/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
BEATcc Trial Summary
This trial is a randomized, open label phase III trial that will investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin/paclitaxel chemotherapy on overall survival in women with metastatic, persistent, or recurrent cervical cancer.
Who is the study for?
This trial is for women over 18 with advanced cervical cancer that can't be cured by surgery or radiation. They should not have had previous systemic therapy for their condition, must be able to follow the study plan, and have a life expectancy of at least 3 months. Participants need good organ function and blood counts, no serious allergies to the drugs being tested, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests if adding Atezolizumab (anti-PD-L1) improves survival when combined with standard chemotherapy (Cisplatin/Carboplatin and Paclitaxel) plus Bevacizumab in stage IVB cervical cancer. It's an open-label phase III study where patients are randomly assigned to two groups without selection based on PD-L1 expression.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, risk of infection due to immune system suppression, potential lung issues like pneumonitis, bleeding risks associated with Bevacizumab, liver or kidney function changes from chemotherapy agents.
BEATcc Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 or older.
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My blood tests show my organs are working well.
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I am fully active or can carry out light work.
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My kidney function is within normal limits.
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I am a woman and I am 18 years old or older.
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My liver is functioning well according to recent tests.
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I haven't had any drug treatments for cancer that has returned or spread.
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I haven't had any drug treatments for cancer that has returned or spread.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cervical cancer cannot be cured with surgery or radiation, and it's confirmed by tests.
BEATcc Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Progression-free survival
Secondary outcome measures
Duration of response
First subsequent therapy
Incidence of Treatment-Emergent Adverse Events of combining atezolizumab to chemotherapy plus bevacizumab compared to cisplatin or carboplatin/paclitaxel (CP) plus bevacizumab.
+5 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
BEATcc Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment4 Interventions
cisplatin 50mg/m2 or carboplatin AUC 5 + paclitaxel 175mg/m2 + bevacizumab 15mg/kg + atezolizumab 1200mg i.v, D1 Q3W.Patients who achieve a complete response after ≥6 treatment cycles may be allowed to continue only on biologics therapy, namely bevacizumab plus atezolizumab, upon investigator discussion.
Group II: Arm AActive Control3 Interventions
Cisplatin 50mg/m2 or carboplatin AUC 5 + paclitaxel 175mg/m2+ bevacizumab 15mg/kg i.v D1 Q3W. Patients who achieve a complete response after ≥6 treatment cycles may be allowed to continue only on biologic therapy, namely bevacizumab, upon investigator discussion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cisplatin/Carboplatin
2015
Completed Phase 3
~280
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Gynecologic Oncology Group FoundationUNKNOWN
1 Previous Clinical Trials
1,000 Total Patients Enrolled
AGO Study GroupOTHER
30 Previous Clinical Trials
15,339 Total Patients Enrolled
Apices Soluciones S.L.Industry Sponsor
37 Previous Clinical Trials
2,914 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 18 or older.You are able to follow the study rules, as determined by the person in charge of the study.My blood tests show my organs are working well.My condition can be treated with the goal of curing it.My cancer is at Stage IVA and cannot be treated with chemo and radiation at the same time.My kidney swelling hasn't improved with specific treatments.I have had radiotherapy with cobalt.I haven't had a stroke, seizure, or similar brain issue in the last 6 months.I have moderate to severe inflammation of my intestines.I have not had a biopsy or minor surgery in the week before starting treatment.I am fully active or can carry out light work.I have a history of lung scarring or inflammation not caused by infections.I have not received a live vaccine in the last 4 weeks.I don't have any health issues that would interfere with the trial drug or its results.I have not had cancer, other than non-melanoma skin cancer, in the last 5 years.I have a serious wound, ulcer, or bone fracture that is not healing.I have had diverticulitis that needed medical treatment.You have a history of a disease where your body's immune system attacks itself.My kidney function is within normal limits.I haven't taken any immune-weakening medications in the last 2 weeks.My cervical cancer cannot be cured with surgery or radiation, and it's not a rare type.I have received first-line treatment for my metastatic or recurrent cervical cancer.I am currently pregnant or breastfeeding.I am allergic to bevacizumab, atezolizumab, or their ingredients.I have had chemotherapy, but only with radiation therapy.I haven't had a blockage in my intestines in the last 6 months.I currently have an active GI bleed or ulcer.I have a history of Crohn's disease or inflammatory bowel disease.I have severe nerve damage in my hands or feet.I frequently need procedures to remove excess fluid from my chest or abdomen.I have high calcium levels that aren't managed without ongoing medication.I have not had severe infections in the last 4 weeks.I haven't had signs of infection in the last 2 weeks.I have not taken any antibiotics by mouth or IV in the last 2 weeks.I don't have any health or mental conditions that would stop me from getting treatment.I have pain from my cancer that isn't relieved by treatment.I have had a severe blood clot in the past.My heart's pumping ability is below the normal range.I am a woman and I am 18 years old or older.My condition involves ongoing issues with my bladder or rectum.I have a condition that causes frequent bleeding.You have a disease that can be measured using a specific medical criteria called RECIST v1.1.I have cancer that has spread to my brain or spinal cord.My liver is functioning well according to recent tests.You must agree to participate in the study by signing a document that explains the details of the study.I am a woman not able to become pregnant or will use birth control during and after the study.I haven't had major surgery or a serious injury in the last 28 days.I haven't had any drug treatments for cancer that has returned or spread.I have a serious heart condition.You are expected to live for at least 3 more months.I haven't had any drug treatments for cancer that has returned or spread.Your blood has enough red and white blood cells, as well as platelets, to meet the minimum levels required for the study.You have participated in a study involving an unapproved medication within the past 4 weeks.I do not have any brain or metabolic conditions that could make experimental treatment risky.I have previously been treated with drugs targeting VEGF, CD137, or immune checkpoints.My side effects from previous treatments are mild, except for hair loss.I am fully active or restricted in physically strenuous activity but can do light work.My cervical cancer cannot be cured with surgery or radiation, and it's confirmed by tests.I am currently on daily aspirin, clopidogrel, or blood thinners.I had surgery on my intestines less than 6 weeks ago.I have active tuberculosis.I haven't taken any immune-boosting drugs in the last 6 weeks.I am HIV positive.You need to provide a sample of your tumor when you start the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the goals that researchers hope to achieve with this experiment?
"The primary goal for this 4-year study is to observe the progression-free survival rate for patients. Additionally, we will be measuring the objective response rate, incidence of treatment-emergent adverse events, and duration of response."
Answered by AI
For what purpose is Atezolizumab commonly prescribed?
"Atezolizumab is most frequently used to treat metastatic ureter urothelial carcinoma. However, it has also been shown to be an effective intervention for other diseases such as lymphoma, non-hodgkin, recurrent cervical cancer, and locally advanced non-small cell lung cancer."
Answered by AI
Are patients being accepted into this clinical trial at this time?
"This clinical trial is not currently seeking new patients. The study was first made public on September 25th, 2018 and the most recent update occurred on February 8th, 2022. If you are interested in finding other similar trials, there are 2085 studies enrolling patients with carcinoma and 2550 for Atezolizumab."
Answered by AI
Is Atezolizumab something that patients can take without fear?
"Atezolizumab is a phase 3 medication, meaning that while there is data supporting its efficacy, multiple rounds of testing have also shown it to be safe."
Answered by AI
Has Atezolizumab been used in any other research studies?
"At the City of Hope Comprehensive Cancer Center, atezolizumab was first studied in 1997. To date, 3102 completed studies exist with 2085 live trials currently underway. A large concentration of these ongoing studies are situated in Richmond, Virginia."
Answered by AI
How many people are being included in this clinical trial?
"Unfortunately, this particular clinical trial is not recruiting right now. It was first posted on September 25th, 2018 and updated February 8th, 2022. However, there are currently 2550 studies actively searching for participants with carcinoma and 2085 trials for Atezolizumab admitting new patients."
Answered by AI
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