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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)

Must not have

Disease suitable for local therapy administered with curative intent

Patients with Stage IVA not amendable to concurrent chemo-radiation as primary treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition can be treated with the goal of curing it.

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My cancer is at Stage IVA and cannot be treated with chemo and radiation at the same time.

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My kidney swelling hasn't improved with specific treatments.

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I have had radiotherapy with cobalt.

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I have moderate to severe inflammation of my intestines.

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I have not had a biopsy or minor surgery in the week before starting treatment.

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I have a history of lung scarring or inflammation not caused by infections.

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I have not had cancer, other than non-melanoma skin cancer, in the last 5 years.

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I have a serious wound, ulcer, or bone fracture that is not healing.

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I have had diverticulitis that needed medical treatment.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I have received first-line treatment for my metastatic or recurrent cervical cancer.

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I am currently pregnant or breastfeeding.

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I am allergic to bevacizumab, atezolizumab, or their ingredients.

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I don't have any health or mental conditions that would stop me from getting treatment.

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I have had chemotherapy, but only with radiation therapy.

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I haven't had a blockage in my intestines in the last 6 months.

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I currently have an active GI bleed or ulcer.

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I have a history of Crohn's disease or inflammatory bowel disease.

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I have severe nerve damage in my hands or feet.

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I have had a severe blood clot in the past.

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My heart's pumping ability is below the normal range.

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I have pain from my cancer that isn't relieved by treatment.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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I have high calcium levels that aren't managed without ongoing medication.

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I have not had severe infections in the last 4 weeks.

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I haven't had signs of infection in the last 2 weeks.

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I have not taken any antibiotics by mouth or IV in the last 2 weeks.

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My condition involves ongoing issues with my bladder or rectum.

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I have a condition that causes frequent bleeding.

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I have cancer that has spread to my brain or spinal cord.

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I haven't had major surgery or a serious injury in the last 28 days.

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I have a serious heart condition.

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I have previously been treated with drugs targeting VEGF, CD137, or immune checkpoints.

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I am currently on daily aspirin, clopidogrel, or blood thinners.

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I have active tuberculosis.

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I haven't taken any immune-boosting drugs in the last 6 weeks.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Progression-free survival

Secondary study objectives

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 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

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.

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

2016

Completed Phase 3

~5860

Cisplatin/Carboplatin

2015

Completed Phase 3

~280