Health Trials

A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

ConditionCancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHoffmann-La Roche

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ipatasertib

    Drug

    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.

  • Tiragolumab

    Drug

    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.

  • Atezolizumab

    Drug

    Atezolizumab will be administered as a monotherapy and in combination 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.

  • Tiragolumab and Atezolizumab

    Drug

    Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) 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.

  • Bevacizumab

    Drug

    Bevacizumab will be administered as a monotherapy or in combination with atezolizumab 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.

  • Entrectinib

    Drug

    Entrectinib 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.

  • Inavolisib

    Drug

    Inavolisib will be administered as a monotherapy or in combination 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.

  • Divarasib

    Drug

    Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Roche IMP(s) MonotherapyExperimental treatment 6 interventions
Group B: Roche Combined AgentsExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)

Time frame
Up to approximately 10 years
2

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

Time frame
Up to approximately 10 years

Secondary outcomes

Other outcomes

Locations

3

Map coordinates are unavailable for these locations. Locations are shown below instead.

Moscow City Oncology Hospital #62Recruiting143423, Moscovskaya Oblast, Moscow OblastRussiaRussia
P.A. Herzen Oncological Inst.Recruiting125248, Moscow, Moscow OblastRussiaRussia
Russian Scientific Center of RoentgenoradiologyActive, not recruiting117997, Moscow, Moscow OblastRussiaRussia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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