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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Sep 2017 → ongoing

Decision date (initial)

2024-02-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche Ltd

External identifiers

EU CT number

2023-506186-57-00

EudraCT number

2016-005189-75

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

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 and who do not have access to the study treatment locally

Secondary objectives 2

1. To evaluate the safety following exposure to atezolizumab monotherapy or atezolizumab administered with combined agent(s)
2. To evaluate overall survival following exposure to atezolizumab monotherapy or atezolizumab administered with combined agent(s) (For patients from Impower 133 study only)

Conditions and MedDRA coding

Cancer (Future parent protocols may include other cancer that are not included in this section)

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): 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, with no access to commercially available comparator agent.
2. Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): 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.
3. Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator.
4. Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Able to comply with the extension study, in the investigator’s judgment; Negative blood pregnancy test within 7 days prior to start of study treatment in women of childbearing potential.
5. Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in survival follow-up at the time of IMpower133 parent study closure
6. Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Eligible for continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent protocol and have access to commercially available atezolizumab (Tecentriq®) outside this extension study at the time of the IMpower133 parent-study closure.

Exclusion criteria 6

1. Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
2. Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient.
3. 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
4. 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
5. 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)
6. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. N/A (Not Applicable)

Secondary endpoints 3

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 (as indicated in parent study protocol) to death due to any cause (For patients from Impower 133 only)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 1

Locations

6 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications