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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: Ipatasertib; Drug: Tiragolumab; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Entrectinib; Drug: Inavolisib; Drug: Tiragolumab and Atezolizumab; Drug: Divarasib

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BX44273 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com
• Study Contact Backup: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

• Belgium
  • Charleroi, Belgium, 6060
    • Completed
    • GHdC Site Les Viviers
  • Kortrijk, Belgium, 8500
    • Active, not recruiting
    • AZ Groeninge
  • Leuven, Belgium, 3000
    • Completed
    • UZ Leuven Gasthuisberg
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Recruiting
      • Princess Margaret Cancer Center
• China
  • Beijing, China, 100142
    • Recruiting
    • Beijing Cancer Hospital
  • Changchun, China, 130021
    • Recruiting
    • The First Hospital of Jilin University
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital of Sichuan University
  • Hangzhou, China, 310022
    • Recruiting
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310016
    • Recruiting
    • Sir Run Run Shaw Hospital Zhejiang University
  • Harbin, China, 150081
    • Recruiting
    • Harbin Medical University Cancer Hospital
  • Hefei, China, 230601
    • Recruiting
    • The Second Affiliated Hospital of Anhui Medical University
  • Meizhou, China, 514031
    • Recruiting
    • Meizhou People's Hospital
  • Nanchang, China, 330052
    • Recruiting
    • The 1st Affiliated Hospital of Nanchang Unversity
  • Nanjing, China, 210029
    • Recruiting
    • Jiangsu Province Hospital of Chinese Medicine
  • Shanghai, China, 200120
    • Recruiting
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 201104
    • Recruiting
    • Shanghai Geriatric Medical Center
  • Xiamen, China, 361003
    • Recruiting
    • The First Affiliated Hospital of Xiamen University
  • Xinxiang, China
    • Recruiting
    • The First Affiliated Hospital of Xinxiang Medical University
  • Zhengzhou, China, 450008
    • Recruiting
    • Henan Cancer Hospital
  • Shaanxi
    • XI 'an City, Shaanxi Province, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
• Costa Rica
  • San José, Costa Rica, 10103
    • Active, not recruiting
    • Clinica CIMCA
  • San José, Costa Rica, 10108
    • Active, not recruiting
    • ICIMED Instituto de Investigación en Ciencias Médicas
• France
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonie
  • Caen, France, 14076
    • Recruiting
    • Centre Francois Baclesse
  • Dijon, France, 21000
    • Recruiting
    • Institut de Cancérologie de Bourgogne
  • Lyon, France, 69373
    • Recruiting
    • Centre Leon Berard
  • Marseille, France, 13005
    • Recruiting
    • Hôpital de la Timone
  • Montpellier, France, 34298
    • Recruiting
    • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
  • Nîmes, France, 30029
    • Completed
    • Institut de cancerologie du Gard
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
  • Paris, France, 75970
    • Recruiting
    • Hopital Tenon
  • Saint-Herblain, France, 44805
    • Recruiting
    • ICO - Site René Gauducheau
  • Toulouse, France, 31059
    • Recruiting
    • Institut Claudius Regaud
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
• Greece
  • Asvestochóri, Greece, 570 10
    • Recruiting
    • General Hospital "G.Papanikolaou"
  • Cholargós, Greece, 155 62
    • Recruiting
    • Metropolitan General Hospital
• Japan
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
  • Kanagawa, Japan, 232-0024
    • Active, not recruiting
    • Yokohama City University Medical Center
  • Kanagawa, Japan, 241-8515
    • Completed
    • Kanagawa Cancer Center
  • Kashiwa-shi, Japan, 277-8577
    • Recruiting
    • National Cancer Center Hospital East
  • Saitama, Japan, 362-0806
    • Recruiting
    • Saitama Cancer Center
  • Sakaishi, Japan, 591-8555
    • Recruiting
    • NHO Kinki-Chuo Chest Medical Center
• Mexico
  • Durango, Mexico, 34000
    • Active, not recruiting
    • Consultorio de Especialidad en Urologia Privado
  • Sinaloa
    • Culiacán, Sinaloa, Mexico
      • Active, not recruiting
      • Centro Medico Culiacan SA de CV
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Completed
      • Medical Care & Research
• Poland
  • Gda?sk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Warsaw, Poland, 02-781
    • Recruiting
    • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
• Russia
  • Moscow Oblast
    • Moscovskaya Oblast, Moscow Oblast, Russia, 143423
      • Recruiting
      • Moscow City Oncology Hospital #62
    • Moscow, Moscow Oblast, Russia, 117997
      • Active, not recruiting
      • Russian Scientific Center of Roentgenoradiology
    • Moscow, Moscow Oblast, Russia, 125248
      • Recruiting
      • P.A. Herzen Oncological Inst.
• South Korea
  • Seongnam-si, South Korea, 463-707
    • Completed
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Active, not recruiting
    • Asan Medical Center
• Taiwan
  • Taichung, Taiwan, 407
    • Recruiting
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 70457
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 110
    • Recruiting
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Active, not recruiting
    • Chang Gung Memorial Hospital - Linkou
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
  • Bangkok, Thailand, 10330
    • Active, not recruiting
    • Chulalongkorn Hospital
  • Chiang Mai, Thailand, 50200
    • Active, not recruiting
    • Maharaj Nakorn Chiangmai Hospital
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • Recruiting
    • Leicester Royal Infirmary
  • Surrey, United Kingdom, SM2 5PT
    • Completed
    • Royal Marsden Hospital - Surrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: RO5532961; 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.; Other Names: RO5541267; 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.; Other Names: RO4876646; 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.; Other Names: RO7102122; 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.; Other Names: RO7113755; 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.; Other Names: RO7435846
Experimental: 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.	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.; Other Names: RO7092284; 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.; Other Names: RO5541267; 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.; Other Names: RO4876646; 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.; Other Names: RO7113755; 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.; Other Names: RO7538483; 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.; Other Names: RO7435846

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)	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	Up to approximately 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Up to approximately 10 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; ipatasertib; atezolizumab; Tiragolumab; entrectinib; inavolisib
• Other Study ID Numbers: BX44273; 2022-003414-36 (EudraCT Number); 2023-504263-16-00 (Ctis: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No