Clinical trial NCT05862285: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)
timeFrame: Up to approximately 10 years
measure: 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
timeFrame: Up to approximately 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: GHdC Site Les Viviers
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: San José
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: Dijon
country: France
facility: Institut de Cancérologie de Bourgogne
city: Montpellier
country: France
facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
city: Nimes
country: France
facility: Institut de cancerologie du Gard
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Culiacan
country: Mexico
facility: Centro Medico Culiacan SA de CV
state: Sinaloa
city: Mérida
country: Mexico
facility: Medical Care & Research
state: Yucatan
city: Durango
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst.
state: Moskovskaja Oblast
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Chiangmai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Surrey
country: United Kingdom
facility: Royal Marsden Hospital - Surrey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: