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Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin

NCT05118724 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-15

No results posted yet for this study

Summary

The investigators hypothesize that atezolizumab will improve the prognosis of patients with stage III dMMR CRC ineligible for or refusing oxaliplatin-based adjuvant chemotherapy compared to SOC and that these could therefore be promising therapeutic options.

Conditions

Interventions

DRUG

Atezolizumab

Atezolizumab 840mg i.v., on Day 1 and Day 15 (q2w) of every 28-day treatment cycle for a total of 12 cycles (24 doses)

DRUG

IMM-101

Suspension of Heat-Killed Whole Cell Mycobacterium obuense (NCTC 13365) in Borate Buffered Saline for Intradermal Injection

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Immodulon Therapeutics Ltd

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Stefan Kasper-Virchow, MD · Universitätsklinikum Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118724 on ClinicalTrials.gov