ClinicalTrials.gg
WithdrawnNCT06331598IMperatorUpdated Dec 24, 2024

A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors with Resectable Disease with Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)

A Phase 2 interventional study of Atezolizumab and Tiragolumab in Solid Tumors, sponsored by Hoffmann-La Roche. Withdrawn at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Global desprioritization decision by the sponsor.

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Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is being conducted to evaluate efficacy parameters (disease free survival [DFS] and overall survival [OS]) of atezolizumab and atezolizumab in combination with tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence.

02

Conditions studied

  • Solid Tumors
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 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

Ages eligible
18 Years and older
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

  • (ECOG) performance status of 0 to 1
  • Any of the following solid tumors considered to be resectable with a curative intent: non-small cell lung cancer, skin melanoma, skin squamous cell carcinoma, urothelial carcinoma, colorectal cancer, gastric cancer, endometrial cancer, cervix cancer, head and neck cancer and any other tumor type with known high TMB (≥ 13 mut/MB) or MSI-H
  • Participants must undergo standard treatment according to the stage of their disease and investigator´s choice
  • All participants must be disease free after standard therapy to be included in this study
  • Having TMB ≥ 13 mut/MB or MSI-H in tumor tissue obtained prior to starting standard treatment or from surgical specimens and analyzed using F1 CDx
  • Participants must be at intermediate/high risk of recurrence
  • Adequate hematologic and organ function
  • Female participants of and male participants with female partners of childbearing potential must be willing to avoid pregnancy
  • Women who are not or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.

Exclusion criteria

Exclusion Criteria:

  • Previous within 3 years prior to enrollment, with the exception of those with a negligible risk of or death treated with expected curative outcome
  • Prior cancer immunotherapy
  • Women who are pregnant, lactating, or intending to become pregnant during the study
  • History of disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Significant cardiovascular disease
  • Treatment with systemic medications within 2 weeks prior to inclusion
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug, whichever is longer, prior to randomization.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Atezolizumab

    Participants will be treated with atezolizumab every 4 weeks (Q4W) for 12 cycles (cycle = 28 days). After study treatment discontinuation participants will be followed until disease progression and afterwards, survival follow-up and new anti-cancer therapy will be collected until death (unless the participant withdraws consent, is lost to follow-up or the Sponsor terminates the study).

    Drug: Atezolizumab

  • Experimental
    Atezolizumab + Tiragolumab

    Participants will be treated with atezolizumab and tiragolumab Q4W for 12 cycles (cycle = 28 days). After study treatment discontinuation participants will be followed until disease progression and afterwards, information on survival follow-up and new anti-cancer therapy will be collected until death (unless the participant withdraws consent, is lost to follow-up or the Sponsor terminates the study).

    Drug: Atezolizumab · Drug: Tiragolumab

Interventions

  • A dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.

    Also known as: Tecentriq

  • A dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.

    Also known as: MTIG7192A

06

What researchers measure

Primary outcomes

  1. Disease Free Survival (DFS) Rate at 24 Months

    Time frame: Month 24

Secondary outcomes

  1. DFS Rate at 36, 48 and 60 Months

    Time frame: Months 36, 48, 60

  2. OS (Overall Survival)

    Time frame: From randomization to death from any cause (up to approximately 60 months)

  3. Percentage of Participants With Adverse Events

    Time frame: Up to approximately 60 months

07

Study locations

3 sites
  • Hospital Universitari Vall dHebron; Oncology
    Barcelona, 08035, Spain
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
    Madrid, 28041, Spain
  • Hospital Universitario Virgen; Servicio de Oncologia
    Sevilla, 41013, Spain
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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2024 (actual). Primary completion is estimated for Oct 2028, 46 months after the start.

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

Registered
Mar 19, 2024
First posted
Mar 26, 2024
StartActual
Nov 30, 2024
Primary completionEst.
Oct 20, 2028
CompletionEst.
Sep 20, 2029
Last update
Dec 24, 2024
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.
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06331598
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Mar 26, 2024
Start date
Nov 30, 2024
Primary completion
Oct 20, 2028 (estimated)
Completion
Sep 20, 2029 (estimated)
Last update
Dec 24, 2024

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Atezolizumab · Tiragolumab

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