Trial Title:
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
NCT ID:
NCT05862285
Condition:
Cancer
Conditions: Official terms:
Atezolizumab
Ipatasertib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ipatasertib
Description:
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.
Arm group label:
Roche IMP(s) Monotherapy
Other name:
RO5532961
Intervention type:
Drug
Intervention name:
Tiragolumab
Description:
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.
Arm group label:
Roche Combined Agents
Other name:
RO7092284
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab will be administered as a monotherapy and in combination with tiragolumab 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.
Arm group label:
Roche Combined Agents
Arm group label:
Roche IMP(s) Monotherapy
Other name:
RO5541276
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.
Criteria for 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 study treatment or comparator agent 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AZ Groeninge
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
Clinica CIMCA
Address:
City:
San José
Zip:
10103
Country:
Costa Rica
Status:
Active, not recruiting
Facility:
Name:
ICIMED Instituto de Investigación en Ciencias Médicas
Address:
City:
San José
Zip:
10108
Country:
Costa Rica
Status:
Active, not recruiting
Facility:
Name:
Institut de cancerologie du Gard
Address:
City:
Nimes
Zip:
30029
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Yokohama City University Medical Center
Address:
City:
Kanagawa
Zip:
232-0024
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Kanagawa
Zip:
241-8515
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
463-707
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Health Pharma Professional Research
Address:
City:
Cdmx
Zip:
03100
Country:
Mexico
Status:
Withdrawn
Facility:
Name:
Centro Medico Culiacan SA de CV; Consultorio Medico 303 B
Address:
City:
Culiacan
Country:
Mexico
Status:
Active, not recruiting
Facility:
Name:
Medical Care & Research
Address:
City:
Mérida
Zip:
97070
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Consultorio de Especialidad en Urologia Privado
Address:
City:
Durango
Zip:
34000
Country:
Mexico
Status:
Active, not recruiting
Facility:
Name:
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Address:
City:
Warszawa
Zip:
04-073
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Moscow City Oncology Hospital #62
Address:
City:
Moscovskaya Oblast
Zip:
143423
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Russian Scientific Center of Roentgenoradiology
Address:
City:
Moscow
Zip:
117997
Country:
Russian Federation
Status:
Active, not recruiting
Facility:
Name:
P.A. Herzen Oncological Inst. ; Oncology
Address:
City:
Moscow
Zip:
125248
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital; Division of Urology
Address:
City:
Taichung
Zip:
407
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Memorial Hospital - Linkou
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Active, not recruiting
Facility:
Name:
Chulalongkorn Hospital; Medical Oncology
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Active, not recruiting
Facility:
Name:
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Address:
City:
Chiangmai
Zip:
50200
Country:
Thailand
Status:
Active, not recruiting
Facility:
Name:
Leicester Royal Infirmary
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital - Surrey
Address:
City:
Surrey
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Start date:
June 1, 2023
Completion date:
March 1, 2033
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862285
