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NCT03762018 · REGISTRY CONDITION SEARCH

BEAT-meso: Bevacizumab and Atezolizumab in Malignant Pleural Mesothelioma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-07-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

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

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Disease Control (DC) at 24 Weeks

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outcome · POSTED

Time to Treatment Failure (TTF)

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outcome · POSTED

Duration of Response (DoR)

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outcome · POSTED

Quality of Life (QoL)

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outcome · POSTED

Adverse Events

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Drug: Carboplatin
    2. Drug: Pemetrexed
    3. Drug: Bevacizumab
    label
    Bevacizumab plus chemotherapy
    type
    ACTIVE_COMPARATOR
  2. description
    Atezolizumab 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
    intervention Names
    1. Drug: Carboplatin
    2. Drug: Pemetrexed
    3. Drug: Bevacizumab
    4. Drug: Atezolizumab
    label
    Atezolizumab plus bevacizumab plus chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Atezolizumab plus bevacizumab plus chemotherapy
    2. Bevacizumab plus chemotherapy
    description
    Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed.
    name
    Carboplatin
    other Names
    1. Carboplatin Accord
    type
    DRUG
  2. arm Group Labels
    1. Atezolizumab plus bevacizumab plus chemotherapy
    2. Bevacizumab plus chemotherapy
    description
    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.
    name
    Pemetrexed
    other Names
    1. Alimta
    type
    DRUG
  3. arm Group Labels
    1. Atezolizumab plus bevacizumab plus chemotherapy
    2. Bevacizumab plus chemotherapy
    description
    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.
    name
    Bevacizumab
    other Names
    1. Avastin
    type
    DRUG
  4. arm Group Labels
    1. Atezolizumab plus bevacizumab plus chemotherapy
    description
    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.
    name
    Atezolizumab
    other Names
    1. Tecentriq
    2. RO5541267
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
400
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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).
    measure
    Overall Survival (OS)
    time Frame
    From randomization until death from any cause, up to 52 months.
secondary Outcomes
  1. description
    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).
    measure
    Progression-free Survival (PFS) According to the mRECIST v1.1
    time Frame
    From randomization until documented progression (PD) according to mRECIST v1.1 or death from any cause (whichever occurred first), up to 52 months.
  2. description
    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.
    measure
    Objective Response Rate (ORR)
    time Frame
    From randomization to termination of trial treatment, up to 52 months.
  3. description
    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.
    measure
    Disease Control (DC) at 24 Weeks
    time Frame
    From randomization to 24 weeks; participants assessed for treatment response status at 24 weeks.
  4. description
    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.
    measure
    Time to Treatment Failure (TTF)
    time Frame
    From randomization until discontinuation of protocol treatment for any reason, up to 52 months.
  5. description
    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.
    measure
    Duration of Response (DoR)
    time Frame
    From documentation of objective response until the date of first documented progression/relapse or death, up to 52 months.
  6. description
    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.
    measure
    Quality of Life (QoL)
    time Frame
    From randomization until 12 weeks after treatment start, up to 52 months.
  7. description
    Adverse events, according to CTCAE v5.0.
    measure
    Adverse Events
    time Frame
    From randomization to 90 days after the last dose of protocol treatment, up to 52 months.
Full study description
brief 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. 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.
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.
Source references
references
  1. citation
    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.
    pmid
    12860938
    type
    BACKGROUND
  2. citation
    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.
    pmid
    26719230
    type
    BACKGROUND
  3. citation
    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.
    pmid
    23860535
    type
    BACKGROUND
  4. citation
    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.
    pmid
    26205340
    type
    BACKGROUND
  5. citation
    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.
    pmid
    26826488
    type
    BACKGROUND
  6. citation
    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.
    pmid
    27571927
    type
    BACKGROUND
  7. citation
    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.
    pmid
    17534390
    type
    BACKGROUND
  8. citation
    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.
    pmid
    18227828
    type
    BACKGROUND
  9. citation
    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.
    pmid
    23977545
    type
    BACKGROUND
  10. citation
    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.
    pmid
    29753121
    type
    BACKGROUND
  11. citation
    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.
    pmid
    33358660
    type
    DERIVED
Source notices and limitations
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    Preserved source evidence · Not medical advice