A continuation study of atezolizumab in different tumor types
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Advanced MalignanciesMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2018-003352-20-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1000
Participants must meet the following criteria for study entry:
1. Signed extension study Informed Consent Form
2. Eligible for continuing atezolizumab-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
3. Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. 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.
4. Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator.
5. Able to comply with this extension study, in the investigator’s judgment.
6. Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential.
7. Will comply with contraception criteria detailed below:
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
For female participants of childbearing potential, agreement (by participant) to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per year during the treatment period and for the period after the last dose of study treatment specified in the designated Referenced Safety Information (RSI).
Women must refrain from donating eggs during this same period. Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilisation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
For men (when required by the designated RSI): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for the period after the last dose of study treatment specified in the designated RSI. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for the duration of the pregnancy to avoid exposing the embryo. The reliability of sexual
abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal
are not acceptable methods of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adult
Participants who meet any of the following criteria will be excluded from study entry:
1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study.
2. Study treatment or comparator agent is commercially marketed in the participant’s country for the patient-specific disease and is accessible to the participant.
3. 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 this extension study (if applicable).
4. Ongoing serious adverse event(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.
5. Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the patient at high risk for treatment-related complications.
6. Concurrent participation in any therapeutic clinical study (other than the parent study).
7. Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated Reference Safety Information.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principal research objective is to provide continued atezolizumab-based treatment and/or comparator medications to eligible participants from a previous Genentech or Roche-sponsored study who do not have access to the study treatment locally.;Secondary Objective: The secondary objective of the study is to identify any new safety indicators related to atezolizumab-based therapy or in treatment with atezolizumab in combination with other medications in patients who are eligible to participate in this extension study.;Primary end point(s): Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.;Timepoint(s) of evaluation of this end point: Throughout the whole study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A