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SNCTP000003090 | NCT03148418 | BASEC2018-01639

Etude menée chez des patients ayant déjà participé à une étude sur l’atezolizumab, financée par Genentech et/ou F. Hoffmann-La Roche Ltd (IMbrella A)

Data source: BASEC (Imported from 25.09.2020), WHO (Imported from 20.09.2020)
Changed: 20.09.2020
Disease category: Lung Cancer

Brief description of trial (Data source: BASEC)

Etude d’extension observationnelle à long terme ayant pour but de permettre aux patients éligibles ayant déjà participé à une étude sur l’atezolizumab (dite «étude-parent») désormais clôturée de continuer à recevoir le traitement à base d’atezolizumab (marque: Tecentriq®) et/ou le ou les agents comparateurs. En parallèle, l’étude continuera de recueillir des données relatives à la sécurité d’emploi du produit et à la survie des patients recevant un traitement à base d’atezolizumab ou un comparateur.

Health conditions investigated (Data source: BASEC)

Cancer avancé ou métastatique

Health conditions (Data source: WHO)

Cancer

Rare disease (Data source: BASEC)

No

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

L’immunothérapie est un type de traitement qui aide le système immunitaire à tuer les cellules cancéreuses.
L’atezolizumab est une immunothérapie dont l’action consiste à bloquer, dans les cellules cancéreuses, une certaine voie de signalisation (la voie PD-L1) qui, sans cela, empêcherait les cellules immunitaires d’attaquer les cellules cancéreuses.
Dans cette étude, l’atezolizumab sera administré seul ou en association avec un ou plusieurs autres agents ou agents comparateurs, comme dans l’étude-parent. Le schéma posologique sera conforme à l’étude-parent correspondante et à l’information professionnelle locale.

Interventions (Data source: WHO)

Drug: Atezolizumab

Criteria for participation in trial (Data source: BASEC)

Les patients qui seront recrutés dans la partie traitement de l’étude et qui continueront à recevoir le traitement à base d’atezolizumab, doivent obligatoirement répondre aux critères suivants :
• Être éligible à la poursuite de l’atezolizumab, l’agent(s) comparateur(s), ou passer au traitement à base d’atezolizumab au moment de la clôture de l’étude parent
• Dans l’étude d’extension, la première dose du traitement à l’étude sera administrée au cours de la phase d’interruption thérapeutique autorisée par l’étude-parent.
• Continuer, de l’avis de l’investigateur, de tirer des bénéfices du traitement à base d’atezolizumab à l’étude ou du comparateur au moment de la clôture de l’étude-parent.

Les patients qui seront recrutés dans la partie observation de l’étude doivent obligatoirement répondre aux critères suivants :
• Arrêter le traitement à base d’atezolizumab dans le cadre de l’étude-parent et dans le cadre du suivi de la survie au moment de la clôture de l’étude-parent, ou être éligible pour continuer le traitement à base d’atezolizumab ou passer au traitement à base d’atezolizumab, conformément au protocole de l’étude-parent, et avoir accès à l’atezolizumab commercialisé (Tecentriq) en dehors de cette étude d’extension au moment de la clôture de l’étude-parent.

Exclusion criteria (Data source: BASEC)

Les patients qui seront recrutés dans la partie traitement de l’étude et continueront à recevoir le traitement à base d’atezolizumab, seront exclus de l’étude si l’un des critères suivants est satisfait :
• Répondre à l’un quelconque des critères d’arrêt du traitement à l’étude précisés dans l’étude-parent au moment du recrutement des participants de l’étude d’extension.
• Le traitement à l’étude est commercialisé en Suisse spécifiquement pour la maladie dont souffre le patient, et il est disponible pour le patient.
• Toute maladie grave concomitante non maîtrisée qui contre-indiquerait l’utilisation du traitement à l’étude au moment de l’étude d’extension ou qui exposerait le participant à un risque élevé de complications liées au traitement.
Les patients qui seront recrutés dans la partie observation de l’étude seront exclus de l’étude, si l’un des critères suivants est satisfait :
• Arrêt du comparateur dans le cadre de l’étude-parent et dans le cadre du suivi de la survie au moment de la clôture de l’étude-parent.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

Specific criteria for patients who continue treatment as well as safety and survival
follow-up in the extension study (and survival follow up for pattients who roll over from
IMpower133):

- Eligible for continuing or crossing over to atezolizumab-based therapy at the time of
the parent-study closure as per the parent study or eligible for continuing the
comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the
parent-study closure as per the parent study, with no access to commercially available
comparator agent

- First dose of study treatment in the extension study will be received within 7 days of
the treatment interruption window allowed by the parent study

- Continue to benefit from atezolizumab-based study treatment or from the comparator at
the time of parent-study closure as assessed by the investigator

- Negative serum pregnancy test within 7 days prior to start of study treatment in women
of childbearing potential

Specific criteria for patients from the IMpower133 parent study only who do not continue
treatment in the extension study and/or receive commercially available atezolizumab
(Tecentriq) outside this extension study and continue safety and survival follow-up only in
the extension study:

- Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in
survival follow- up at the time of IMpower133 parent study closure, or eligible for
continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent
protocol and have access to commercially available atezolizumab (Tecentriq) outside this
extension study at the time of the IMpower133 parent-study closure

Exclusion Criteria:

Specific criteria for patients who continue treatment as well as safety and survival
follow-up in the extension study:

- Meet of any of the study treatment discontinuation criteria specified in the parent
study at the time of enrollment in the extension study

- Study treatment is commercially marketed in the patient's country for the patient
specific disease and is accessible to the patient

- Time between the last dose of treatment received in parent study and first dose in
extension study is longer than the interruption period (± 7 days) allowed in the
parent study

- Treatment with any anti-cancer treatment (other than treatment permitted in the parent
study) during the time between last treatment in the parent study and the first dose
of study treatment in the extension study

- Permanent discontinuation of atezolizumab for any reason during the parent study or
during the time between last treatment in the parent study and the first dose of study
treatment in the extension study (if applicable)

- Any unresolved or irreversible toxicities during the parent study that required
permanent discontinuation of study treatment, in accordance to the parent study or
local prescribing information

- Ongoing SAE(s) that has not resolved to baseline level or Grade less than or equal to
(<=) 1 from the parent study or during the time between last treatment in the parent
study and the first dose of study treatment in the extension study

- Any serious uncontrolled concomitant disease that would contraindicate the use of
study treatment at the time of the extension study or that would place the participant
at high risk for treatment-related complications

- Concurrent participation in any therapeutic clinical trial (other than the parent
study)

Specific criteria for patients who do not continue treatment in the extension study and/or
receive commercially available atezolizumab (Tecentriq) outside this extension study and
continue safety and survival follow-up only in the extension study:

- Discontinuation of comparator in parent study and in survival follow-up at the time of
parent study closure

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03148418

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03148418

Further information on trial

Date trial registered

09.05.2017

Incorporation of the first participant

20.09.2017

Recruitment status

Recruiting

Academic title (Data source: WHO)

An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)

Secundary end point (Data source: WHO)

Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0;Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0;Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only

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)

Lausanne

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, New Zealand, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Clinical Trials
+41 61 715 43 91
switzerland.clinical-research@roche.com

Contact for general information (Data source: WHO)

Clinical Trials;Reference Study ID Number: BO39633 www.roche.com/about_roche/ roche_worldwide.htm
Hoffmann-La Roche
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Contact for scientific information (Data source: WHO)

Clinical Trials;Reference Study ID Number: BO39633 www.roche.com/about_roche/ roche_worldwide.htm
Hoffmann-La Roche
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Hoffmann-La Roche

Authorisation by the ethics committee (Data source: BASEC)

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

Commission cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)

Date of authorisation by the ethics committee

11.12.2018

Further trial identification numbers

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

2018-01639

Secondary ID (Data source: WHO)

2016-005189-75
BO39633