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SNCTP000003301 | NCT03762018 | BASEC2018-02138

Studie zum Vergleich von Atezolizumab plus Bevacizumab und Standard-Chemotherapie mit Bevacizumab und Standard-Chemotherapie als Erstlinienbehandlung von Patienten mit Lungenkrebs, der als malignes Pleuramesotheliom bezeichnet wird.

Data source: BASEC (Imported from 28.03.2024), WHO (Imported from 20.03.2024)
Changed: Dec 23, 2023, 4:39 PM
Disease category: Lung Cancer

Brief description of trial (Data source: BASEC)

Ziel der Studie ist die Beurteilung der Wirkung eines monoklonalen Antikörpers namens Atezolizumab (TECENTRIQ®) bei Patienten mit Lungenkrebs, der als Malignes Pleuramesotheliom (MPM) bezeichnet wird. Wir wollen die Wirksamkeit (ob die Behandlung wirkt) sowie die Sicherheit und Verträglichkeit (Nebenwirkungen der Behandlung) von Atezolizumab plus Bevacizumab in Kombination mit Standard-Chemotherapie beurteilen. Die Patienten/ Patientinnen werden zufällig der Behandlung 1 (Bevacizumab in Kombination mit Standard-Chemotherapie) oder Behandlung 2 (Atezolizumab plus Bevacizumab in Kombination mit Standard-Chemotherapie) zugewiesen, ungefähr so, wie bei einer Auslosung oder beim Werfen einer Münze. Weder der Patient/ die Patientin noch der Arzt können entscheiden oder beeinflussen, welche Behandlung dem Patient/ der Patientin zugewiesen wird (dies wird als „Randomisierung“ bezeichnet). Die Wahrscheinlichkeit, dass der Patient/ die Patientin Behandlung 1 oder Behandlung 2 erhalten, ist gleich hoch. Es wird erwartet, dass insgesamt 320 Patienten aus etwa 45 Studienzentren in Europa in diese Studie eingeschlossen werden. Die Studie wird bis zu ihrem Abschluss ungefähr 6 Jahre dauern. In der Schweiz ist geplant, dass 30 Patienten/ Patientinnen an der Studie teilnehmen.

Health conditions investigated(Data source: BASEC)

Lungenkrebs, der als "malignes Pleuramesotheliom" bezeichnet wird, im fortgeschrittenen Stadium oder nach übergreifen auf andere Körperteile (Metastarierung).

Health conditions (Data source: WHO)

Pleural Mesothelioma Malignant Advanced

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

BEHANDLUNG 1:
– Bevacizumab 15 mg / kg, intravenös verabreicht an Tag 1 jedes 3-wöchigen Zyklus, plus
– 4-6 Zyklen Chemotherapie (Carboplatin & Pemetrexed)
ODER
BEHANDLUNG 2:
– Atezolizumab 1200 mg Fixdosis, intravenös verabreicht an Tag 1 jedes 3-wöchigen Zyklus, plus
– Bevacizumab 15 mg / kg, intravenös verabreicht an Tag 1 jedes 3-wöchigen Zyklus, plus
– 4-6 Zyklen Chemotherapie (Carboplatin & Pemetrexed)

Interventions (Data source: WHO)

Drug: Carboplatin;Drug: Pemetrexed;Drug: Bevacizumab;Drug: Atezolizumab

Criteria for participation in trial (Data source: BASEC)

- Histologisch bestätigtes fortgeschrittenes malignes Pleuramesotheliom
- Malignes Pleuramesotheliom ist nicht geeignet für chirurgischen Eingriff
- Verfügbarkeit von Tumorgewebe
- Lebenserwartung >3 Monate
- Angemessene Blut-, Nieren- und Leber-Funktion.

Exclusion criteria (Data source: BASEC)

- Vorangehende Therapie des malignen Pleuramesotheliom
- Therapie mit Medikamenten, welche das Immunsystem stimulieren
- Therapie mit Medikamenten, welche das Immunsystem hemmen
- Vorangehende Transplantation
- ungenügend kontrollierter Bluthochdruck
- signifikante Gefässerkrankung

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03762018

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03762018
Further information on trial

Date trial registered

Nov 20, 2018

Recruitment status

Active, not recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Overall Survival (OS)

Secundary end point (Data source: WHO)

Progression-free Survival (PFS) according to the mRECIST v1.1;Objective Response Rate (ORR);Disease Control (DC) at 24 weeks;Time to Treatment Failure (TTF);Duration of Response (DoR);Number of participants with treatment related adverse events according to Common Toxicity Criteria for Adverse Events (CTCAE) v5.0

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Bellinzona, Bern, Chur, Lausanne, Luzern, St. Gallen, Winterthur, Zurich

Countries (Data source: WHO)

Belgium, France, Italy, Portugal, Slovenia, Spain, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Barbara Reupp
+41 31 511 94 16
etop-regulatory@etop.ibcsg.org

Contact for general information (Data source: WHO)

Enriqueta Felip, MD-PhD;Sanjay Popat, PhD, MBBS
Vall d'Hebron University Hospital;Royal Marsden NHS Foundation Trust

Contact for scientific information (Data source: WHO)

Enriqueta Felip, MD-PhD;Sanjay Popat, PhD, MBBS
Vall d'Hebron University Hospital;Royal Marsden NHS Foundation Trust

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Bern

Date of authorisation by the ethics committee

04.04.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-02138

Secondary ID (Data source: WHO)

2018-002180-25
MO40388
ETOP 13-18
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