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

NCT05862285 | Recruiting Phase 3

• 3 other identifiers: BX442732022-003414-362023-504263-16-00
• Study Type: interventional
• Target: 100
• Locations: 14 countries
• Sites: 57

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Roche IMP(s) Monotherapy

EXPERIMENTAL

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; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Entrectinib; Drug: Inavolisib; Drug: Divarasib

Roche Combined Agents

EXPERIMENTAL

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; Drug: Atezolizumab; Drug: Tiragolumab and Atezolizumab; Drug: Bevacizumab; Drug: Inavolisib; Drug: Divarasib

Interventions

Divarasib DRUG

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.

Also known as: RO7435846

Roche Combined Agents; Roche IMP(s) Monotherapy

Ipatasertib DRUG

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.

Also known as: RO5532961

Roche IMP(s) Monotherapy

Tiragolumab DRUG

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.

Also known as: RO7092284

Roche Combined Agents

Atezolizumab DRUG

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.

Also known as: RO5541267

Roche Combined Agents; Roche IMP(s) Monotherapy

Bevacizumab DRUG

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.

Also known as: RO4876646

Roche Combined Agents; Roche IMP(s) Monotherapy

Entrectinib DRUG

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.

Also known as: RO7102122

Roche IMP(s) Monotherapy

Tiragolumab and Atezolizumab DRUG

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.

Also known as: RO7538483

Roche Combined Agents

Inavolisib DRUG

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.

Also known as: RO7113755

Roche Combined Agents; Roche IMP(s) Monotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (57)

GHdC Site Les Viviers

Charleroi, 6060, Belgium

COMPLETED

AZ Groeninge

Kortrijk, 8500, Belgium

ACTIVE NOT RECRUITING

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

XI 'an City, Shaanxi Province, Shaanxi, 710061, China

RECRUITING

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

the First Hospital of Jilin University

Changchun, 130021, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, 610041, China

RECRUITING

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, 310016, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, 150081, China

RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, 230601, China

RECRUITING

Meizhou People's Hospital

Meizhou, 514031, China

RECRUITING

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, 330052, China

RECRUITING

Jiangsu Province Hospital of Chinese Medicine

Nanjing, 210029, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

RECRUITING

Shanghai Geriatric Medical Center

Shanghai, 201104, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, 361003, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, 450008, China

RECRUITING

Clinica CIMCA

San José, 10103, Costa Rica

ACTIVE NOT RECRUITING

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

ACTIVE NOT RECRUITING

Institut Bergonie

Bordeaux, 33076, France

RECRUITING

Centre Francois Baclesse

Caen, 14076, France

RECRUITING

Institut de Cancérologie de Bourgogne

Dijon, 21000, France

RECRUITING

Hopital de la Timone

Marseille, 13005, France

RECRUITING

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

Montpellier, 34298, France

RECRUITING

Institut de cancerologie du Gard

Nîmes, 30029, France

ACTIVE NOT RECRUITING

Hopital Tenon

Paris, 75970, France

RECRUITING

ICO - Site René Gauducheau

Saint-Herblain, 44805, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31059, France

RECRUITING

Gustave Roussy

Villejuif, 94800, France

RECRUITING

General Hospital "G.Papanikolaou"

Asvestochóri, 570 10, Greece

RECRUITING

Metropolitan General Hospital

Cholargós, 155 62, Greece

RECRUITING

Kyushu University Hospital

Fukuoka, 812-8582, Japan

RECRUITING

Yokohama City University Medical Center

Kanagawa, 232-0024, Japan

ACTIVE NOT RECRUITING

Kanagawa Cancer Center

Kanagawa, 241-8515, Japan

COMPLETED

National Cancer Center Hospital East

Kashiwa-shi, 277-8577, Japan

RECRUITING

Saitama Cancer Center

Saitama, 362-0806, Japan

RECRUITING

NHO Kinki-Chuo Chest Medical Center

Sakaishi, 591-8555, Japan

RECRUITING

Centro Medico Culiacan SA de CV

Culiacán, Sinaloa, Mexico

ACTIVE NOT RECRUITING

Medical Care & Research

Mérida, Yucatán, 97070, Mexico

COMPLETED

Consultorio de Especialidad en Urologia Privado

Durango, 34000, Mexico

ACTIVE NOT RECRUITING

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

Warsaw, 02-781, Poland

RECRUITING

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

RECRUITING

Russian Scientific Center of Roentgenoradiology

Moscow, Moscow Oblast, 117997, Russia

ACTIVE NOT RECRUITING

P.A. Herzen Oncological Inst.

Moscow, Moscow Oblast, 125248, Russia

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

COMPLETED

Asan Medical Center

Seoul, 05505, South Korea

ACTIVE NOT RECRUITING

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 70457, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 110, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou

Taoyuan District, 333, Taiwan

ACTIVE NOT RECRUITING

Chulalongkorn Hospital

Bangkok, 10330, Thailand

ACTIVE NOT RECRUITING

Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, 50200, Thailand

ACTIVE NOT RECRUITING

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

RECRUITING

Royal Marsden Hospital - Surrey

Surrey, SM2 5PT, United Kingdom

COMPLETED

MeSH Terms

Conditions

Neoplasms

Interventions

ipatasertib; Tiragolumab; atezolizumab; Bevacizumab; entrectinib; inavolisib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BX44273 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 17, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (15); GB (2); BE (3); PL (1); JP (6); FR (10); RU (3); CO (2); CA (1); GR (2); ME (3); TW (4); KR (2); TH (3)