A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
NCT ID: NCT05862285
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2023-06-01
2033-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Roche IMP(s) Monotherapy
Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.
Ipatasertib
Ipatasertib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Atezolizumab
Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.
Bevacizumab
Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Entrectinib
Entrectinib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Inavolisib
Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Divarasib
Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Roche Combined Agents
Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.
Tiragolumab
Tiragolumab in combination with atezolizumab will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Atezolizumab
Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.
Tiragolumab and Atezolizumab
Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Bevacizumab
Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Inavolisib
Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Divarasib
Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Interventions
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Ipatasertib
Ipatasertib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Tiragolumab
Tiragolumab in combination with atezolizumab will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Atezolizumab
Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.
Tiragolumab and Atezolizumab
Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Bevacizumab
Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Entrectinib
Entrectinib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Inavolisib
Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Divarasib
Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
* First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
* Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator
* Ability to comply with the extension study protocol, per Investigator's judgement
Exclusion Criteria
* Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant
* 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 this extension study
* Permanent discontinuation of all study treatment(s) or comparator agent(s) 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 this extension study (if applicable)
* Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
* Concurrent participation in any therapeutic clinical trial (other than the parent study)
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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GHdC Site Les Viviers
Charleroi, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Beijing Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital of Sichuan University
Chengdu, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Meizhou People's Hospital
Meizhou, , China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, , China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, , China
Henan Cancer Hospital
Zhengzhou, , China
Clinica CIMCA
San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José, , Costa Rica
Centre Francois Baclesse
Caen, , France
Institut de Cancérologie de Bourgogne
Dijon, , France
Hopital de la Timone
Marseille, , France
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
Montpellier, , France
Institut de cancerologie du Gard
Nîmes, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
General Hospital "G.Papanikolaou"
Asvestochóri, , Greece
Metropolitan General Hospital
Cholargós, , Greece
Kyushu University Hospital
Fukuoka, , Japan
Yokohama City University Medical Center
Kanagawa, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
National Cancer Center Hospital East
Kashiwa-shi, , Japan
Saitama Cancer Center
Saitama, , Japan
NHO Kinki-Chuo Chest Medical Center
Sakaishi, , Japan
Centro Medico Culiacan SA de CV
Culiacán, Sinaloa, Mexico
Medical Care & Research
Mérida, Yucatán, Mexico
Consultorio de Especialidad en Urologia Privado
Durango, , Mexico
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
Russian Scientific Center of Roentgenoradiology
Moscow, Moscow Oblast, Russia
P.A. Herzen Oncological Inst.
Moscow, Moscow Oblast, Russia
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan District, , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, , Thailand
Leicester Royal Infirmary
Leicester, , United Kingdom
Royal Marsden Hospital - Surrey
Surrey, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: BX44273 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
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BX44273
Identifier Type: -
Identifier Source: org_study_id
2022-003414-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504263-16-00
Identifier Type: CTIS
Identifier Source: secondary_id