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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) (IMperator)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512635-71-00
Acronym
ML43332
Enrollment
40
Registered
2024-05-17
Start date
2024-03-14
Completion date
2024-12-09
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumors

Brief summary

The primary endpoint is the Disease Free Survival (DFS) rate at 24 months defined as the proportion of patients who have not suffered any of the following since the time of randomization: first documented recurrence of disease, new primary tumor or death due to any cause, whichever occurs first

Detailed description

DFS rate at 36, 48 and 60 months, OS (Overall Survival) after randomization, defined as the time from randomization to death from any cause, Incidence and severity of AEs, with severity determined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Change from baseline in targeted clinical laboratory test results, Tumor biomarker: Percentage of PDL1 positive cells versus DFS and OS, Genomics: Genomic alterations related to resistance to immunotherapy versus DFS and OS

Interventions

Sponsors

Roche Farma S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the Disease Free Survival (DFS) rate at 24 months defined as the proportion of patients who have not suffered any of the following since the time of randomization: first documented recurrence of disease, new primary tumor or death due to any cause, whichever occurs first

Secondary

MeasureTime frame
DFS rate at 36, 48 and 60 months, OS (Overall Survival) after randomization, defined as the time from randomization to death from any cause, Incidence and severity of AEs, with severity determined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Change from baseline in targeted clinical laboratory test results, Tumor biomarker: Percentage of PDL1 positive cells versus DFS and OS, Genomics: Genomic alterations related to resistance to immunotherapy versus DFS and OS

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026