An Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2016-005189-75-CZ
• Date of registration: 28/06/2017
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: An Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study
• Scientific title: AN OPEN-LABEL, MULTICENTER EXTENSION AND LONG-TERM OBSERVATIONAL STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH- AND/OR F. HOFFMANN LA ROCHE LTD-SPONSORED ATEZOLIZUMAB STUDY
• Date of first enrolment: 13/07/2017
• Target sample size: 556
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-005189-75
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Czech Republic, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or
Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study
- First dose of study treatment in the extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
- Able to comply with the extension study, in the investigator's judgment
- Will comply with contraception criteria detailed in BO39633 protocol
- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential

2. Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of atezolizumab-based therapy in parent study and in survival follow up at the time of parent study closure
or
- Eligible for continuing or crossing over to atezolizumab-based therapy as per the parent protocol and have access to commercially available atezolizumab (Tecentriq®) outside this extension study at the time of the parent-study closure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 278
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 278

Exclusion criteria:
1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
- Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient
- Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (+/- 7 days) allowed in the parent study.
- 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 the extension study
- Permanent discontinuation of atezolizumab 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 the extension study (if applicable)
- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade <= 1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the patient at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
- Pregnant or lactating, or intending to become pregnant during the extension study

2. Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available Tecentriq®outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of comparator in parent study and in survival follow-up at the time of parent study closure


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cancer (Future parent protocols may include other cancer that are not included in this section)
MedDRA version: 21.0 Level: LLT Classification code 10046721 Term: Urothelial carcinoma bladder stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.1 Level: LLT Classification code 10023400 Term: Kidney cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Avastin
Product Name: Bevacizumab
Product Code: RO4876646
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: SUTENT
Product Name: Sunitinib
Product Code: RO4632993
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB
CAS Number: 557795-19-4
Current Sponsor code: RO4632993
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 12.5-50

Trade Name: Javlor
Product Name: vinflunine
Product Code: RO7059926
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: VINFLUNINE
CAS Number: 162652-95-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: Tecentriq
Product Name: Atezolizumab (MPDL3280A)
Product Code: RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary Objective: - To evaluate the safety following exposure of atezolizumab monotherapy or atezolizumab administered with combined agent(s)
- To evaluate overall survival following exposure of atezolizumab monotherapy or atezolizumab administered in combination with other agent(s)

Main Objective: To provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure

Primary end point(s): Not applicable

Secondary Outcome(s)

Secondary end point(s): 1. Incidence and severity of serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0
2. Incidence and severity of adverse events of special interest, with severity determined according to NCI CTCAE, v4.0
3. Time from randomization or treatment initiation to death due to any cause

Timepoint(s) of evaluation of this end point: 1-3. Throughout the study

Secondary ID(s)

BO39633

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date:
Contact: