A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

Last updated: April 7, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Cancer

Treatment

Atezolizumab

Bevacizumab

Inavolisib

Clinical Study ID

NCT05862285
BX44273
2022-003414-36
2023-504263-16-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible for continuing Roche IMP-based therapy at the time of roll-over from theparent study, as per the parent study protocol OR

  • Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsoredstudy as per the parent study protocol, with no access to commercially availablecomparator agent

  • First dose of study treatment in this extension study will be received within 7 daysof the treatment interruption window allowed by the parent study

  • Continue to benefit from the Roche IMP-based therapy or comparator at the time ofroll-over from the parent study as assessed by the investigator

  • Ability to comply with the extension study protocol, per Investigator's judgement

Exclusion

Exclusion Criteria:

  • Meet any of the study treatment discontinuation criteria specified in the parentstudy at the time of enrollment in this extension study

  • Study treatment or comparator agent is commercially marketed in the participant'scountry for the participant-specific disease and is accessible to the participant

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

  • Permanent discontinuation of all study treatment(s) or comparator agent(s) for anyreason during the parent study or during the time between last treatment in theparent study and the first dose of study treatment in this extension study (ifapplicable)

  • Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parentstudy or during the time between the last treatment in the parent study and thefirst dose of study treatment in this extension study

  • Concurrent participation in any therapeutic clinical trial (other than the parentstudy)

Study Design

Total Participants: 60
Treatment Group(s): 7
Primary Treatment: Atezolizumab
Phase: 3
Study Start date:
June 01, 2023
Estimated Completion Date:
March 01, 2033

Connect with a study center

  • GHdC Site Les Viviers

    Charleroi, 6060
    Belgium

    Active - Recruiting

  • GHdC Site Notre Dame

    Charleroi, 6060
    Belgium

    Active - Recruiting

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 1Z5
    Canada

    Active - Recruiting

  • Clinica CIMCA

    San José, 10103
    Costa Rica

    Site Not Available

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108
    Costa Rica

    Site Not Available

  • Institut de Cancérologie de Bourgogne

    Dijon, 21000
    France

    Active - Recruiting

  • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

    Montpellier, 34298
    France

    Active - Recruiting

  • Institut de cancerologie du Gard

    Nimes, 30029
    France

    Site Not Available

  • ICO - Site René Gauducheau

    Saint Herblain, 44805
    France

    Active - Recruiting

  • Kanagawa Cancer Center

    Kanagawa, 241-8515
    Japan

    Completed

  • Yokohama City University Medical Center

    Kanagawa, 232-0024
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Health Pharma Professional Research

    Cdmx, Mexico CITY (federal District) 03100
    Mexico

    Site Not Available

  • Centro Medico Culiacan SA de CV

    Culiacan, Sinaloa
    Mexico

    Site Not Available

  • Centro Medico Culiacan SA de CV; Consultorio Medico 303 B

    Culiacan, Sinaloa
    Mexico

    Site Not Available

  • Medical Care & Research

    Mérida, Yucatan 97070
    Mexico

    Active - Recruiting

  • Consultorio de Especialidad en Urologia Privado

    Durango, 34000
    Mexico

    Site Not Available

  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

    Warszawa, 04-073
    Poland

    Site Not Available

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moskovskaja Oblast 143423
    Russian Federation

    Active - Recruiting

  • P.A. Herzen Oncological Inst.

    Moscow, Moskovskaja Oblast 125248
    Russian Federation

    Active - Recruiting

  • P.A. Herzen Oncological Inst. ; Oncology

    Moscow, Moskovskaja Oblast 125248
    Russian Federation

    Active - Recruiting

  • Russian Scientific Center of Roentgenoradiology

    Moscow, Moskovskaja Oblast 117997
    Russian Federation

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital; Division of Urology

    Taichung, 407
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei City, 110
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chulalongkorn Hospital

    Bangkok, 10330
    Thailand

    Site Not Available

  • Chulalongkorn Hospital; Medical Oncology

    Bangkok, 10330
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiangmai Hospital

    Chiangmai, 50200
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

    Chiangmai, 50200
    Thailand

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital - Surrey

    Surrey, SM2 5PT
    United Kingdom

    Active - Recruiting

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