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Pleural Mesothelioma Malignant AdvancedPhase 3BEAT-mesoNCT03762018

BEAT-meso: Bevacizumab and Atezolizumab in Malignant Pleural Mesothelioma

A Phase 3 study testing Carboplatin, Pemetrexed and Bevacizumab in people with Pleural Mesothelioma Malignant Advanced, run by ETOP IBCSG Partners Foundation at 42 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pleural Mesothelioma Malignant Advanced
What is being tested?
Carboplatin, Pemetrexed and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
42 sitesin 6 countries
Study dates
30 Apr 2019to 18 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed advanced malignant pleural mesothelioma (all histological subtypes are eligible)
  • Not amenable for radical surgery based on local standards
  • Evaluable disease or measurable disease as assessed according to the modified response evaluation criteria for solid tumours for mesothelioma (mRECIST) v1.1
  • Availability of tumour tissue for translational research
  • Age >18 years
  • Performance Status 0-1
Show all 11Show fewer
  • Life expectancy >3 months
  • Adequate haematological, renal and liver function
  • Completed baseline quality of life (QoL) questionnaire
  • Women of childbearing potential and sexually active men must agree to use highly effective contraception
  • Able to understand and give written informed consent and comply with trial procedures

Who cannot join

  • Prior treatment for malignant pleural mesothelioma. Prior radiotherapy for symptom control is allowed, but the irradiated lesion cannot be used as target lesion. If the patient has another target lesion, the patient is eligible.
  • Treatment with systemic immune-stimulatory agents within 4 weeks or five half-lives of the drug prior to randomisation and during protocol treatment.
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation and during protocol treatment.
  • Previous allogeneic tissue/solid organ transplant
  • Live vaccines within 4 weeks prior to first dose of protocol treatment
  • Inadequately controlled hypertension
Show all 13Show fewer
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Significant vascular disease within 6 months prior to randomisation
  • History of haemoptysis
  • Evidence of bleeding diathesis or coagulopathy
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • History of active diverticulitis
  • Previous treatment with atezolizumab and/or bevacizumab or parallel participation in other interventional clinical trial with atezolizumab and/or bevacizumab.

Trial locations and contacts

42 sites in 6 countries.

42 sites in 6 countries

United Kingdom10 sites

  • Addenbrooke's Hospital

    Cambridge

  • Clatterbridge Cancer Centre

    Liverpool

  • Guy's and St Thomas' Hospital

    London

  • Royal Marsden Hospital (Fulham Road)

    London

  • Royal Marsden Hospital (Sutton)

    London

  • Kent Oncology Centre

    Maidstone

  • Wythenshawe Hospital

    Manchester

  • Plymouth Hospitals NHS Trust

    Plymouth

  • Weston Park Hospital

    Sheffield

  • Royal Cornwall Hospital

    Truro

Other trials in United Kingdom

Switzerland9 sites

  • Kantonsspital Aarau

    Aarau

  • Istituto Oncologica della Svizzera Italiana

    Bellinzona

  • Ferdinando Cerciello

    Bern

  • Kantonsspital Graubünden

    Chur

  • CHUV

    Lausanne

  • Luzerner Kantonsspital

    Lucerne

  • Kantonsspital St. Gallen

    Sankt Gallen

  • Kantonsspital Winterthur

    Winterthur

  • UniversitätSpital Zürich

    Zurich

Other trials in Switzerland

France8 sites

  • Unicancer - Institut Bergonie

    Bordeaux

  • Caen- CHU

    Caen

  • Le Mans - CHG

    Le Mans

  • Lyon - Centre Léon Bérard

    Lyon

  • Hospital Nord

    Marseille

  • Curie Cancer Center Paris

    Paris

  • Toulouse - CHU

    Toulouse

  • Tours - CHU

    Tours

Other trials in France

Spain7 sites

  • Alicante University Hospital ISABIAL

    Alicante

  • ICO Hospitalet

    Barcelona

  • Vall Hebron University Hospital/Vall Hebron Institue Oncology

    Barcelona

  • Puerta de Hierro Hospital

    Majadahonda

  • Hospital Parc Tauli Sabadell

    Sabadell

  • Virgen del Rocio

    Seville

  • Complexo Hospitalario Universitario de Vigo

    Vigo

Other trials in Spain

Italy6 sites

  • SS Antonio e Biagio e Cesare Arrigo Hospital

    Alessandria

  • IRCCS Instituto Tumori Giovanni Paolo II

    Bari

  • Fondazione IRCCS Istituto Nazionale die Tumori

    Milan

  • Instituto Europeo di Oncologia (IEO)

    Milan

  • AULSS2 Marca Trevigiana Treviso

    Treviso

  • University Hospital of Turin

    Turin

Other trials in Italy

Belgium2 sites

  • University Hospital Leuven

    Leuven

  • CHU Liege

    Liège

Other trials in Belgium

About this study

Official title: A Multicentre Randomised Phase III Trial Comparing Atezolizumab Plus Bevacizumab and Standard Chemotherapy Versus Bevacizumab and Standard Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma

The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. The efficacy (whether the treatment works), safety and tolerability (side effects of treatment) of atezolizumab plus bevacizumab in combination with standard chemotherapy versus bevacizumab in combination with standard chemotherapy will be investigated.

Read the detailed description

Malignant pleural mesothelioma (MPM) is a rare and aggressive cancer arising from the mesothelial surface of the pleura. In Europe, the incidence is about 20 per million and is almost always caused by asbestos exposure, with a usual lag time of 30 years between exposure and presentation. Patients diagnosed with advanced MPM have limited treatment options, representing a strict unmet need. Despite decades of clinical research, cytotoxic chemotherapy remains one of the few therapeutic options that has been proven to improve survival in advanced MPM in a randomised controlled trial.

The combination of cisplatin and pemetrexed has become standard first-line therapy worldwide for patients who are not suitable for aggressive surgery or in whom chemotherapy is recommended as part of a multimodality regimen. Carboplatin is often substituted for cisplatin, due to simpler and shorter administration and assumption of a more favourable toxicity profile based on experience in other diseases. Patients with MPM have limited treatment options, representing a strict unmet need.

An antibody is a common type of protein usually made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. The two monoclonal antibodies (atezolizumab and bevacizumab) used in this trial are laboratory-produced antibodies. Atezolizumab is engineered to attach to immune cells to stimulate their activity against cancer cells.

Atezolizumab and bevacizumab are both approved by the European Medicines Agency for the treatment of lung and other cancers. The addition of atezolizumab to bevacizumab plus standard chemotherapy for the treatment of MPM is being investigated in this trial.

All participants will receive 4-6 cycles of standard chemotherapy consisting of carboplatin AUC 5 (area under the plasma concentration versus time curve) plus pemetrexed 500mg/m^2 given intravenously, on day 1 of every 3 week cycle for about 12 to 18 weeks.

Participants will be randomly assigned to one of two treatment groups:

Treatment 1

  • Bevacizumab 15 mg/kg intravenously on day 1 of every 3-week cycle, plus
  • 4-6 cycles of chemotherapy

OR

Treatment 2

  • Atezolizumab 1200 mg fixed dose intravenously on day 1 of every 3-week cycle, plus
  • Bevacizumab 15 mg/kg, intravenously on day 1 of every 3-week cycle, plus
  • 4-6 cycles of chemotherapy

Participants will continue to receive treatment until disease progression, or until treatment is stopped at the request of the participant or treating doctor, or the participant withdraws consent.

A total of 400 participants from approximately 45 centres in Europe are expected to be included in this trial which will take approximately 6 years to be completed after the first participant is enrolled.

Keywords
MPM

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Carboplatin Accord

    Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed.

  • PemetrexedDrug

    Also called Alimta

    Pemetrexed is a type of drug known as an anti metabolite. It stops cells making and repairing DNA so they can't grow and multiply.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab is an angiogenesis inhibitor. It works by targeting a protein called vascular endothelial growth factor (VEGF) that helps cancers form new blood vessels. By stopping this process, bevacizumab 'suffocates' the blood supply to the cancer, shrinking it and stopping it from growing.

  • AtezolizumabDrug

    Also called Tecentriq, RO5541267

    Atezolizumab is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in cancer cells. This helps the immune system to fight against the cancer cells, and helps to slow tumor growth.

Study groups in NCT03762018
Study groupRoleWhat they receive
Bevacizumab plus chemotherapyActive comparatorBevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks
Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Bevacizumab
Atezolizumab plus bevacizumab plus chemotherapyExperimentalAtezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks
Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Bevacizumab; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival is defined as the time from the date of randomisation until death from any cause. Data for patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Data for patients without post-baseline information will be censored at the date of randomization (plus 1 day).

    Measured: From randomization until death from any cause, up to 52 months.

Secondary outcomes (7)

  1. Progression-free Survival (PFS) According to the mRECIST v1.1

    PFS is defined as the time from the date of randomisation until documented progression (according to the mRECIST v1.1) or death, if progression is not documented. Censoring (for participants without a PFS/death event) will occur at the date of last tumour assessment. Patients without a post-baseline tumour assessment will be censored at the date of randomization (plus 1 day).

    Measured: From randomization until documented progression (PD) according to mRECIST v1.1 or death from any cause (whichever occurred first), up to 52 months.

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the percentage of patients that achieve a best overall response [complete response (CR) or partial response (PR)] evaluated according to the mRECIST v1.1 across all post-randomization time-points until the end of protocol treatment. Confirmation of response will not be required.

    Measured: From randomization to termination of trial treatment, up to 52 months.

  3. Disease Control (DC) at 24 Weeks

    Disease Control (DC) is defined as complete or partial response, or disease stabilisation at 24 weeks (+/- 10 days). Patients with no available scan at this time period, but with scan performed before 24 weeks - 10 days and scan performed after 24 weeks + 10 days showing disease control, will be considered as disease control.

    Measured: From randomization to 24 weeks; participants assessed for treatment response status at 24 weeks.

  4. Time to Treatment Failure (TTF)

    Time to Treatment Failure (TTF) is defined as the time from the date of randomisation to discontinuation of protocol treatment for any reason (including progression of disease, death, discontinuation of at least one of the drugs consisting the treatment combination due to any reason, such as toxicity or refusal). Censoring will occur at the last follow-up date.

    Measured: From randomization until discontinuation of protocol treatment for any reason, up to 52 months.

  5. Duration of Response (DoR)

    Duration of Response (DoR) is defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented progression/relapse or death.

    Measured: From documentation of objective response until the date of first documented progression/relapse or death, up to 52 months.

  6. Quality of Life (QoL)

    QoL is assessed by the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) an 8-item questionnaire including five symptoms associated with mesothelioma (i.e., appetite loss, fatigue, cough, dyspnoea, and pain) and three items addressing symptomatic distress, normal activity, and global QoL. All items are measured by visual analogue scales (VAS) using 100-mm lines to assess the intensity of each item based on patient responses within the time frame of the past day. Each item is assigned an individual score corresponding to the length of the line representing intensity as marked by the patient on a 0-100 scale, with 0 as the best rating (i.e., no symptom distress, no interference with activity level, or best possible health-related quality of life) and 100-mm as the worst rating. The primary QoL endpoint is the change in the LCSS total score (average of all 8 items) from baseline to 12 weeks after treatment start.

    Measured: From randomization until 12 weeks after treatment start, up to 52 months.

  7. Adverse Events

    Adverse events, according to CTCAE v5.0.

    Measured: From randomization to 90 days after the last dose of protocol treatment, up to 52 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start30 Apr 2019
  3. Primary completion1 Sep 2023
  4. Study completion18 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03762018
Sponsor's protocol ID
ETOP 13-18
Other IDs
2018-002180-25, MO40388, 2018
Acronym
BEAT-meso
Status last verified
Apr 2026
First submitted
20 Nov 2018
Last updated
22 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.

    PubMed 12860938

  • Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Riviere F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21.

    PubMed 26719230

  • Ceresoli GL, Zucali PA, Mencoboni M, Botta M, Grossi F, Cortinovis D, Zilembo N, Ripa C, Tiseo M, Favaretto AG, Soto-Parra H, De Vincenzo F, Bruzzone A, Lorenzi E, Gianoncelli L, Ercoli B, Giordano L, Santoro A. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma. Br J Cancer. 2013 Aug 6;109(3):552-8. doi: 10.1038/bjc.2013.368. Epub 2013 Jul 16.

    PubMed 23860535

  • Melero I, Berman DM, Aznar MA, Korman AJ, Perez Gracia JL, Haanen J. Evolving synergistic combinations of targeted immunotherapies to combat cancer. Nat Rev Cancer. 2015 Aug;15(8):457-72. doi: 10.1038/nrc3973.

    PubMed 26205340

  • Soto-Ortiz L, Finley SD. A cancer treatment based on synergy between anti-angiogenic and immune cell therapies. J Theor Biol. 2016 Apr 7;394:197-211. doi: 10.1016/j.jtbi.2016.01.026. Epub 2016 Jan 27.

    PubMed 26826488

  • Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Canamero M, Babitski G, Koeppen H, Ziai J, Sharma N, Gaire F, Chen DS, Waterkamp D, Hegde PS, McDermott DF. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma. Nat Commun. 2016 Aug 30;7:12624. doi: 10.1038/ncomms12624.

    PubMed 27571927

  • Tsiouris A, Walesby RK. Malignant pleural mesothelioma: current concepts in treatment. Nat Clin Pract Oncol. 2007 Jun;4(6):344-52. doi: 10.1038/ncponc0839.

    PubMed 17534390

  • Fennell DA, Gaudino G, O'Byrne KJ, Mutti L, van Meerbeeck J. Advances in the systemic therapy of malignant pleural mesothelioma. Nat Clin Pract Oncol. 2008 Mar;5(3):136-47. doi: 10.1038/ncponc1039.

    PubMed 18227828

  • Nowak AK. Chemotherapy for malignant pleural mesothelioma: a review of current management and a look to the future. Ann Cardiothorac Surg. 2012 Nov;1(4):508-15. doi: 10.3978/j.issn.2225-319X.2012.10.05. No abstract available.

    PubMed 23977545

  • Armato SG 3rd, Nowak AK. Revised Modified Response Evaluation Criteria in Solid Tumors for Assessment of Response in Malignant Pleural Mesothelioma (Version 1.1). J Thorac Oncol. 2018 Jul;13(7):1012-1021. doi: 10.1016/j.jtho.2018.04.034. Epub 2018 May 9.

    PubMed 29753121

  • Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2. No abstract available.

    PubMed 33358660

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Pemetrexed and Bevacizumab in people with Pleural Mesothelioma Malignant Advanced, run by ETOP IBCSG Partners Foundation at 42 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United Kingdom, Switzerland, France, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization until death from any cause, up to 52 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03762018, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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