METIMMOX-3 for patients with recently diagnosed bowel cancer with spread to other organs

Lab values

• •Patient has metastatic MSI/dMMR-CRC •Patient has initially resectable metastatic disease for which neoadjuvant therapy is deemed superfluous •Patient has supradiaphragmatic metastatic disease as the sole site(s) •Patient has untreated or symptomatic brain metastasis (patient must be symptom-free without the use of corticosteroids) •Patient has experienced a period of less than 6 months since discontinuation of neoadjuvant or adjuvant oxaliplatin-containing chemotherapy •Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle •Patient has partial or complete DPD deficiency •Patient has had radiation therapy against the only measurable lesion within 4 weeks of start of study treatment •Patient has a medical condition treated with anticoagulant medication that cannot be replaced by LMWH or a direct oral anticoagulant during active study treatment •Patient has a nervous system disorder worse than CTCAE grade 1 •Patient has any medical condition that will preclude him/her from treatment with an immune checkpoint inhibitor •Patient with current or prior use of immunosuppressive medication within 28 days before the first dose of study therapy, with the exceptions of intranasal corticosteroids or systemic corticosteroids at physiological doses that do not exceed 10mg/day of prednisone or an equivalent corticosteroid •Patient has any medical condition or needs to use medication, as listed in the IB/SmPC of each IMP/authorized IMP, that will preclude him/her from receiving treatment with IMP/authorized IMP •Patient has undergone treatment with any IMP/authorized IMP that may interfere with the study treatment within 4 weeks prior to first administration of study drug •Patient has known hypersensitivity to any of the study IMP/authorized IMP components •Patient has ECOG performance status 2 or worse •Patient has serum/plasma CRP of 60 mg/L or higher •Patient does not have laboratory values indicative of adequate organ function •Patient has history of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB, stage I prostate cancer considered not necessary to treat, and another malignancy that was treated with curative intent more than 5 years ago and has not relapsed since •Patient has significant cardiac, pulmonary, or other medical illness that would limit ADL or survival •Patient is pregnant or breastfeeding •Patient has any other reason, in the opinion of the investigator, not to participate in the study

• •Patient has histologically verified MSS/pMMR-CRC adenocarcinoma (also comprising the mucinous adenocarcinoma and signet-ring cell carcinoma entities) •Patient has tumor specimen (biopsy or surgical specimen) that can undergo NGS analysis by the OCAP platform •Patient is ambulatory with ECOG performance status 0 or 1 •Patient is at least 18 years of age •Patient has radiologically measurable metastatic disease, including at least one infradiaphragmatic metastatic lesion •Patient has not had previous systemic cytotoxic therapy for the metastatic disease, except for previous neoadjuvant treatment discontinued 6 months or longer ago •Patient is eligible for the FLOX/FOLFOX with bevacizumab regimen when it would be the preferred treatment option for first-line therapy in routine practice •Patient has laboratory values within 14 days prior to study entry indicative of adequate organ function •WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug •WOCBP will use an adequate method to avoid pregnancy for a period of 26 weeks after the last therapy dose •Woman is not breastfeeding •Male who is sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 26 weeks after the last therapy dose •Signed ICF and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH-GCP and national/local regulations