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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT05118724
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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)
  • IMM-101 — DRUG
    Suspension of Heat-Killed Whole Cell Mycobacterium obuense (NCTC 13365) in Borate Buffered Saline for Intradermal Injection

Study Details

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.

Key Dates

Start date
Dec 10, 2021
Status verified
Jun 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Atezolizumab 840mg i.v. (q2w) for a total of 12 cycles (24 doses)
  • Experimental: IMM-101 plus atezolizumab
    One initial dose of IMM-101 intradermally at 1.0 mg 14 ±2 days before start of atezolizumab treatment (same as Arm A)

Primary Outcome Measure

Disease-free Survival (DFS) [ Time Frame: at 3 years ]

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