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RecruitingNCT05862285UmbrellaMAXUpdated Nov 6, 2026

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

A Phase 3 interventional study of Ipatasertib and Tiragolumab in Cancer, sponsored by Hoffmann-La Roche. Recruiting at 85 sites in 15 countries. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 5 months later.
Updated Nov 6, 2026Enrollment updatedEligibility revised+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer

Browse trials for

03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 6, 2026. See what changed

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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)
  • 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. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant.
  • Concurrent participation in any therapeutic clinical trial (other than the parent study)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Roche IMP(s) Monotherapy

    Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.

    Drug: Ipatasertib · Drug: Atezolizumab · Drug: Bevacizumab · Drug: Entrectinib · Drug: Inavolisib · Drug: Divarasib · Drug: Giredestrant

  • Experimental
    Roche Combined Agents

    Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.

    Drug: Tiragolumab · Drug: Atezolizumab · Drug: Tiragolumab and Atezolizumab · Drug: Bevacizumab · Drug: Inavolisib · Drug: Divarasib · Drug: Giredestrant

Interventions

  • 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.

    Also known as: RO5532961

  • 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.

    Also known as: RO7092284

  • 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.

    Also known as: RO5541267

  • DrugTiragolumab and Atezolizumab

    Drug pages: Tiragolumab · Atezolizumab

    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.

    Also known as: RO7538483

  • 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.

    Also known as: RO4876646

  • 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.

    Also known as: RO7102122

  • 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.

    Also known as: RO7113755

  • 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.

    Also known as: RO7435846

  • Giredestrant 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.

    Also known as: RO7197597

06

What researchers measure

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

07

Study locations

66 of 85 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Mar 2033, 117 months after the start.

Of 119 industry-sponsored phase 3 interventional studies under Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 72. This study's planned 117 months is above that.

Counting every sponsor, half of 202 studies reached it within 50 months; a quarter within 33 and three quarters within 84.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2023
First posted
May 17, 2023
StartActual
Jun 1, 2023
Primary completionEst.
Mar 1, 2033
CompletionEst.
Mar 1, 2033
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
13 sites added, 1 site removed
Show 13 added (4 China, 3 France, 3 Japan, 2 Russia, 1 Belgium)
  • Zhejiang People's Hospital · Hangzhou, China
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University · Xi'an, China
  • AP-HM- Hôpital de La Timone · Marseille, France
  • CHU de Nantes - Hotel Dieu · Nantes, France
  • Moscow City Oncology Hospital #62 · Moscow, Russia
  • UZ Leuven Gasthuisberg · Leuven, Belgium
  • Shanghai Chest Hospital · Shanghai, China
  • Xi'an International Medical Center Hospital · Xi'an, China
  • Hopitaux de Brabois - Gastro-Entereologie · Vandœuvre-lès-Nancy, France
  • National Hospital Organization Kyushu Medical Center · Chuo-ku, Fukuoka-shi, Japan
  • National Hospital Organization Shikoku Cancer Center · Matsuyama, Japan
  • Iwate Medical University Hospital · Numakunai, Japan
  • I.M.Sechenov First Moscow State Medical University (1st MSMU) · Moskva, Russia
Show 1 removed
  • Moscow City Oncology Hospital #62 · Moscovskaya Oblast, Russia
across 2 updates, Oct 2, 2026 – Nov 6, 2026
Enrollment
100→200
Nov 6, 2026
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedOngoing 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. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant.
Nov 6, 2026
Interventions
Added Drug: Giredestrant
Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    8 sites added
    Show 8 added (3 Japan, 2 China, 1 Belgium, 1 France, 1 Russia)
    • UZ Leuven Gasthuisberg · Leuven, Belgium
    • Shanghai Chest Hospital · Shanghai, China
    • Xi'an International Medical Center Hospital · Xi'an, China
    • Hopitaux de Brabois - Gastro-Entereologie · Vandœuvre-lès-Nancy, France
    • National Hospital Organization Kyushu Medical Center · Chuo-ku, Fukuoka-shi, Japan
    • National Hospital Organization Shikoku Cancer Center · Matsuyama, Japan
    • Iwate Medical University Hospital · Numakunai, Japan
    • I.M.Sechenov First Moscow State Medical University (1st MSMU) · Moskva, Russia
    Enrollment 100→200
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedOngoing 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. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant.
    Interventions Added Drug: Giredestrant
    + 2 other changes: index terms and verification date
  2. Oct 2, 2026
    5 sites added, 1 site removed
    Show 5 added (2 China, 2 France, 1 Russia)
    • Zhejiang People's Hospital · Hangzhou, China
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University · Xi'an, China
    • AP-HM- Hôpital de La Timone · Marseille, France
    • CHU de Nantes - Hotel Dieu · Nantes, France
    • Moscow City Oncology Hospital #62 · Moscow, Russia
    Show 1 removed
    • Moscow City Oncology Hospital #62 · Moscovskaya Oblast, Russia
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05862285
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
May 17, 2023
Start date
Jun 1, 2023
Primary completion
Mar 1, 2033 (estimated)
Completion
Mar 1, 2033 (estimated)
Last update
Nov 6, 2026

Study contacts

Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Ipatasertib · Tiragolumab · Atezolizumab · Inavolisib

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