NCT05862285RecruitingPhase 3
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 1 May 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Mar 2033
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Childhood cancers
- NCT number
- NCT05862285
- EU CT number
- 2023-504263-16-00
- EudraCT number
- 2022-003414-36
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 1 Jun 2023 to the primary completion date, 1 Mar 2033
- 76 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
Other illness
- Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant
Other
- Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GHdC Site Les Viviers Coordinator of this site? Confirm its status | Charleroi | Belgium | Completed |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Active, not recruiting |
| UZ Leuven Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Cancer Center of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| The Second Affiliated Hospital Of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Meizhou People's Hospital Coordinator of this site? Confirm its status | Meizhou | China | Recruiting |
| The 1st Affiliated Hospital of Nanchang Unversity Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Jiangsu Province Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Geriatric Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University Coordinator of this site? Confirm its status | XI 'an City, Shaanxi Province | China | Recruiting |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Clinica CIMCA Coordinator of this site? Confirm its status | San José | Costa Rica | Active, not recruiting |
| ICIMED Instituto de Investigación en Ciencias Médicas Coordinator of this site? Confirm its status | San José | Costa Rica | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Institut de Cancérologie de Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| AP-HM - Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut de Cancérologie du Gard Coordinator of this site? Confirm its status | Nîmes | France | Completed |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| ICO - Site René Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| Royal Marsden Hospital - Surrey Coordinator of this site? Confirm its status | Surrey | United Kingdom | Completed |
| General Hospital "G.Papanikolaou" Coordinator of this site? Confirm its status | Asvestochóri | Greece | Recruiting |
| Metropolitan General Hospital Coordinator of this site? Confirm its status | Cholargós | Greece | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Kanagawa | Japan | Active, not recruiting |
| Toranomon Branch Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Recruiting |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Kanagawa | Japan | Completed |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Saitama | Japan | Recruiting |
| NHO Kinki-Chuo Chest Medical Center Coordinator of this site? Confirm its status | Sakaishi | Japan | Recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Completed |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Centro Medico Culiacan SA de CV Coordinator of this site? Confirm its status | Culiacán | Mexico | Active, not recruiting |
| Consultorio de Especialidad en Urologia Privado Coordinator of this site? Confirm its status | Durango | Mexico | Active, not recruiting |
| Medical Care & Research Coordinator of this site? Confirm its status | Mérida | Mexico | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gda?sk | Poland | Recruiting |
| Szpital Wojewódzki im. Miko?aja Kopernika Coordinator of this site? Confirm its status | Koszalin | Poland | Recruiting |
| Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| P.A. Herzen Oncological Inst. Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| Russian Scientific Center of Roentgenoradiology Coordinator of this site? Confirm its status | Moscow | Russia | Active, not recruiting |
| Moscow City Oncology Hospital #62 Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| Chulalongkorn Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Active, not recruiting |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Maharaj Nakorn Chiangmai Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Active, not recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Active, not recruiting |
| Arensia Exploratory Medicine - Ukraine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.