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

Official title

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

Overview

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.

Interventions

• Drug 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.
• Drug 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.
• Drug 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.
• Drug 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.
• Drug 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.
• Drug 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.
• Drug 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.
• Drug 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.

Primary outcome measures

• Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) [Time frame: Up to approximately 10 years]
• Number and Severity of Participants With Selected Adverse Events Assessed as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 [Time frame: Up to approximately 10 years]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 19 centers

• First Affiliated Hospital of Medical College of Xi'an Jiaotong University — XI 'an City, Shaanxi Province
• Fudan University Shanghai Cancer Center — Shanghai
• Beijing Cancer Hospital — Beijing
• the First Hospital of Jilin University — Changchun
• West China Hospital of Sichuan University — Chengdu
• Cancer Center of Guangzhou Medical University — Guangzhou
• Sir Run Run Shaw Hospital Zhejiang University — Hangzhou
• Zhejiang Cancer Hospital — Hangzhou
• … and 11 more centers

France · 12 centers

• Institut Bergonie — Bordeaux
• Centre Francois Baclesse — Caen
• Institut de Cancérologie de Bourgogne — Dijon
• Centre Leon Berard — Lyon
• Hopital de la Timone — Marseille
• Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque — Montpellier
• Institut de cancerologie du Gard — Nîmes
• Institut Curie — Paris
• … and 4 more centers

Japan · 8 centers

• National Cancer Center Hospital East — Chiba
• Kyushu University Hospital — Fukuoka
• Toranomon Branch Hospital — Kanagawa
• Yokohama City University Medical Center — Kanagawa
• Kanagawa Cancer Center — Kanagawa
• National Cancer Center Hospital East — Kashiwa-shi
• Saitama Cancer Center — Saitama
• NHO Kinki-Chuo Chest Medical Center — Sakaishi

Taiwan · 4 centers

• Taichung Veterans General Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Chang Gung Memorial Hospital - Linkou — Taoyuan

Belgium · 3 centers

• GHdC Site Les Viviers — Charleroi
• AZ Groeninge — Kortrijk
• UZ Leuven Gasthuisberg — Leuven

Mexico · 3 centers

• Centro Medico Culiacan SA de CV — Culiacán
• Medical Care & Research — Mérida
• Consultorio de Especialidad en Urologia Privado — Durango

Russia · 3 centers

• Moscow City Oncology Hospital #62 — Moscovskaya Oblast
• Russian Scientific Center of Roentgenoradiology — Moscow
• P.A. Herzen Oncological Inst. — Moscow

South Korea · 3 centers

• Seoul National University Bundang Hospital — Seongnam-si
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

Thailand · 3 centers

• Chulalongkorn Hospital — Bangkok
• Siriraj Hospital — Bangkok
• Maharaj Nakorn Chiangmai Hospital — Chiang Mai

Costa Rica · 2 centers

• Clinica CIMCA — San José
• ICIMED Instituto de Investigación en Ciencias Médicas — San José

Greece · 2 centers

• General Hospital "G.Papanikolaou" — Asvestochóri
• Metropolitan General Hospital — Cholargós

Poland · 2 centers

• Uniwersyteckie Centrum Kliniczne — Gda?sk
• Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie — Warsaw

United Kingdom · 2 centers

• Leicester Royal Infirmary — Leicester
• Royal Marsden Hospital - Surrey — Surrey

Canada · 1 center

• Princess Margaret Cancer Center — Toronto

Identifiers

NCT: NCT05862285 · BX44273 · 2022-003414-36 · 2023-504263-16-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗