Solid TumorsPhase 2IMperatorNCT06331598
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 study testing Atezolizumab and Tiragolumab in people with Solid Tumors, run by Hoffmann-La Roche at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Atezolizumab and Tiragolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesSpain
- Study dates
- 30 Nov 2024to 20 Sep 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (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 biopsy obtained prior to starting standard treatment or from surgical specimens and analyzed using F1 CDx
- Participants must be at intermediate/high risk of recurrence
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- Adequate hematologic and organ function
- Female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy
- Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
Who cannot join
- Previous malignancies within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis 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 autoimmune 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 immunosuppressive 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Vall dHebron; Oncology
Barcelona, BARCELONA, 08035
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Madrid, 28041
Hospital Universitario Virgen; Servicio de Oncologia
Seville, SEVILLA, 41013
About this study
Official title: A Phase II, Open Label, Randomized, Non-Comparative Cohorts 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)
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.
- Conditions
- Solid Tumors
- Being tested
- Atezolizumab, Tiragolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq
A dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.
TiragolumabDrug
Also called MTIG7192A
A dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab | Experimental | 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). Receives: Drug: Atezolizumab |
| Atezolizumab + Tiragolumab | Experimental | 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). Receives: Drug: Atezolizumab; Drug: Tiragolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS) Rate at 24 Months
Measured: Month 24
Secondary outcomes (3)
DFS Rate at 36, 48 and 60 Months
Measured: Months 36, 48, 60
OS (Overall Survival)
Measured: From randomization to death from any cause (up to approximately 60 months)
Percentage of Participants With Adverse Events
Measured: Up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start30 Nov 2024
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Sep 2029 (estimated)
Why it stopped: Global desprioritization decision by the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331598
- Sponsor's protocol ID
- ML43332
- Other IDs
- 2022-003708-33
- Acronym
- IMperator
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Randomized, Non-Comparative Cohorts 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)
- ClinicalTrials.gov ID
- NCT06331598
- Acronym / sponsor ID
- IMperator / ML43332
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Global desprioritization decision by the sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 20 Oct 2028 (estimated)
- Study completion
- 20 Sep 2029 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab | Experimental | Drug: AtezolizumabParticipants 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). |
| Atezolizumab + Tiragolumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (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 biopsy obtained prior to starting standard treatment or from surgical specimens and analyzed using F1 CDx
Key exclusion criteria (8 listed)
- Previous malignancies within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis 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 autoimmune 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: TecentriqA dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles. | Drug | Atezolizumab, Atezolizumab + Tiragolumab |
| TiragolumabAlso: MTIG7192AA dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles. | Drug | Atezolizumab + Tiragolumab |
Primary outcome
Disease Free Survival (DFS) Rate at 24 Months
Time frame: Month 24
3 secondary outcomes
DFS Rate at 36, 48 and 60 Months
Time frame: Months 36, 48, 60
OS (Overall Survival)
Time frame: From randomization to death from any cause (up to approximately 60 months)
Percentage of Participants With Adverse Events
Time frame: Up to approximately 60 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: 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
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab and Tiragolumab in people with Solid Tumors, run by Hoffmann-La Roche at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) Rate at 24 Months (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.