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Perioperative/Adjuvant atezolizumab in patients with MSI-high or MMRdeficient stage II high risk or stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy– a Phase II study (ANTONIO)
EU CTIS ID: 2024-515224-37-00
What this study is testing
To determine whether atezolizumab alone can significantly improve disease-free survival rate at 3 years compared to historical control when used as adjuvant treatment in patients with MSIhigh/ dMMR stage II high risk or stage III colorectal cancer for whom oxaliplatin regimens are not a viable treatment option
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent including participation in translational research and any locally-required authorization
- INR < 1.5 ULN and PTT < 1.5 ULN within 7 days prior to registration
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly-effective contraception
- Male or female ≥ 18 years of age
- Histologically confirmed adenocarcinoma of the colon or rectum
You likely can't join if
- Severe infection within 4 weeks prior to registration
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Active HBV infection (chronic or acute), defined as having a positive HBsAg test at screening
- Anti-viral therapy against HCV during the trial (allowed prior to trial)
- Positive HIV test. As an exception, known HIV+ patients may be included if they have: A stable regimen of HAART; No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections; A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
- Treatment with a live, attenuated vaccine within 4 weeks prior to first dose of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the last dose of study treatment.
See the full eligibility criteria
Who can join
- Written informed consent including participation in translational research and any locally-required authorization
- INR < 1.5 ULN and PTT < 1.5 ULN within 7 days prior to registration
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly-effective contraception
- Male or female ≥ 18 years of age
- Histologically confirmed adenocarcinoma of the colon or rectum
- Pathological stage II high risk or Stage III disease
- R0 or R1-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)
- ECOG status 0 – 2
- Ineligible for oxaliplatin-based adjuvant chemotherapy or patient's refusal of oxaliplatin-based adjuvant chemotherapy
- Adequate blood count, liver enzymes, and renal function – re-testing can be undergone once in case of initial results near cutoff [(White blood cell count ≥ 3.0 x 10^6/mL (Inclusion is also possible if 2,5 10^6/mL < White blood cell > 3.0 x 10^6/mL, in which case the neutrophils must be >= 1.5 x10^6/ml and the lymphocytes >= 0.5 x10^6/ml))
What rules you out
- Severe infection within 4 weeks prior to registration
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Active HBV infection (chronic or acute), defined as having a positive HBsAg test at screening
- Anti-viral therapy against HCV during the trial (allowed prior to trial)
- Positive HIV test. As an exception, known HIV+ patients may be included if they have: A stable regimen of HAART; No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections; A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
- Treatment with a live, attenuated vaccine within 4 weeks prior to first dose of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the last dose of study treatment.
- Treatment with any vaccine during screening and the first cycle of treatment.
- Active tuberculosis
- Active or history of autoimmune disease or immune deficiency e.g. myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
- Prior (<3 years) or concurrent malignancy that either progresses or requires active treatment. Exceptions: basal cell cancer of the skin, preinvasive cancer of the cervix, T1a or T1b prostate carcinoma, superficial urinary bladder tumor
- History of hypersensitivity to any of the study drugs or any excipient IMM-101
- Distant metastases or residual disease
- Prior allogeneic stem cell or solid organ transplantation requiring immunosuppressive therapy or other major immunosuppressive therapy
- Severe non-healing wounds, ulcers or bone fractions
- Evidence of bleeding diathesis or coagulopathy
- Major gastrointestinal bleeding within 4 weeks prior to treatment start, unless cause of bleeding was resected tumor
- Major surgical procedures other than primary tumor resection, except open biopsy, nor significant traumatic injury within 28 days prior to registration, or anticipation of the need for major surgical procedure during the course of the study except for surgery of central intravenous line placement for chemotherapy administration
- Medication that is known to interfere with any of the agents applied in the trial
- Female subjects who are pregnant or breast-feeding; male or female patients of reproductive potential who are not employing an effective method of birth control as listed in the protocol) (failure rate of less than 1% per year, see protocol section 6.1.3). Women of childbearing potential must have a negative pregnancy test
- Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or affect patient safety or study results
- Participation in another clinical study with an investigational drug within 28 days prior to treatment start or 7 half-lives of previously used trial medication, whichever is longer
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities
- Neoadjuvant radiotherapy or radio-chemotherapy (rectal cancer patients without prior radio- or radio-chemotherapy allowed); prior neoadjuvant radio-chemotherapy or radiotherapy for rectal cancer is allowed if >5 years and secondary colorectal cancer
- Affected persons who might be dependent on the sponsor or the investigator
- Prior adjuvant chemotherapy for colorectal cancer; allowed if >5 years and secondary colorectal cancer
- Prior treatment with atezolizumab or any other checkpoint inhibitor
- Treatment with systemic immunosuppressive medication within 2 weeks prior to treatment start, or anticipation of need for systemic immunosuppressive medication during study treatment
- Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
- History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
- Known hypersensitivity to CHO cell products or any component of the atezolizumab formulation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.