Resumen

Este es un estudio de extensión abierto, multicéntrico, no aleatorizado y con seguimiento observacional a largo plazo. Los participantes que reciben atezolizumab en monoterapia o atezolizumab combinado con otro(s) agente(s) o agente(s) comparador(es) en un estudio patrocinado por Genentech o Roche (el estudio principal) y que continúan recibiendo el tratamiento del estudio al momento del cierre del estudio principal y no tienen acceso al tratamiento del estudio en su localidad son elegibles para continuar el tratamiento en el estudio de extensión. El régimen de dosificación para un participante e indicación determinados será igual o equivalente al protocolo del estudio principal correspondiente. El tratamiento del estudio en el estudio de extensión puede continuar hasta la progresión de la enfermedad o más allá si el paciente continúa obteniendo beneficio clínico a juicio del investigador y si lo permite el estudio principal o la información de prescripción local, hasta la muerte; el retiro del consentimiento del estudio; una toxicidad inaceptable; embarazo; incumplimiento del paciente; o la terminación del estudio por parte del Patrocinador, lo que ocurra primero.

Elegibilidad

Sexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Atezolizumab

Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).

drug

Bevacizumab

Bevacizumab will be administered as directed per the parent study.

Estudio de extensión abierto y multicéntrico con seguimiento observacional a largo plazo en pacientes previamente enrolados en un estudio de atezolizumab patrocinado por Genentech y/o F. Hoffmann-La Roche Ltd