Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Inel… (NCT05118724) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin
Germany80 participantsStarted 2021-12-10
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Written informed consent including participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
✓. Male or female ≥ 18 years of age
✓. Histologically confirmed adenocarcinoma of the colon or rectum
✓. For the main study: Pathological Stage III disease For the perioperative sub-study: Clinical stage III disease
✓. For the main study: R0-resected primary tumor For the perioperative sub-study: Resectable primary tumor; R0 resection anticipated (R1-resected patients can remain on study.)
✓. Tumor is MSI-high (MSI-H) or MMR-deficient (dMMR) For the main study: assessed from biopsy or from resected tumor tissue For the perioperative sub-study: assessed from biopsy
✓. ECOG status 0 - 2
✓. Ineligible for oxaliplatin-based adjuvant chemotherapy or patient's refusal of oxaliplatin-based adjuvant chemotherapy. Oxaliplatin ineligibility criteria are:
Exclusion criteria
✕. Severe infection within 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, known active pulmonary disease with hypoxia, or severe pneumonia or any active infection (bacterial, viral or fungal) requiring systemic therapy within 4 weeks prior to registration. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
✕. For the main study: Distant metastases or residual disease For the perioperative sub-study: Distant metastases or macroscopic residual disease (R2 resection status)
✕. Neoadjuvant radiotherapy or radio-chemotherapy (enrollment of rectal cancer patients without prior radio- or radio-chemotherapy is allowed); prior neoadjuvant radio-chemotherapy (RCT) or radiotherapy (RT) for rectal cancer is allowed if \>5 years and secondary colorectal cancer
✕. Prior adjuvant chemotherapy for colorectal cancer; allowed if \>5 years and secondary colorectal cancer
✕. Prior treatment with atezolizumab or any other checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti- CTLA-4)
✕. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to treatment start, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible. Inhaled corticosteroids for chronic obstructive pulmonary disease or bronchial asthma, supplemental mineralo-corticosteroids or low-dose corticosteroids for adrenal-cortical insufficiency are allowed