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Phase II/ III trial. Randomized: one arm receives standard of care; the other, standard of care and the vaccines.
Vaccines: GRT-C901/GRT-R902, prime and boost of a patient-specific neoantigen cancer vaccine.
Only for patients who are planned for, or have received no more than 1 cycle of first-line treatment fo mCRC, with Folfox in combination with bevacizumab (Avastin).
In the trial, the experimental arm receives 24 weeks of standard of care 1st line chemo and, later, the GRT-C901/GRT-R902 vaccine (6 applications). With the first vaccine application, patients receive also the immunotherapy ipilimumab/ Yervoy (anti CTLA-4). As maintainnace, patients receive the immunotherapy atezolizumab/ Tecentric (anti PD L1)

Exclusion criteria: having BRAFV600E mutated cancer not allowed; MSI-H CRC not allowed.

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纳入标准

纳入标准

* Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received <30 days of first-line treatment in the metastatic setting with FOLFOX/bev, CAPEOX/bev, FOLFOXIRI/bev, or CAPOXIRI/bev per SOC
* Measurable and unresectable metastatic disease according to RECIST v1.1
* Availability of formalin-fixed paraffin-embedded (FFPE) tumor specimens.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient has adequate organ function per defined criteria
* If women of childbearing potential (WCBP), must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 150 days after last investigational study treatment.

排除标准

排除标准：

* Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype
* Patient has a known tumor mutation burden <1 non-synonymous mutations/megabase
* Known DNA Polymerase Epsilon mutations
* Patients with known BRAFV600E mutations
* Bleeding disorder or history of significant bruising or bleeding following IM injections or blood draws
* Immunosuppression anticipated at time of study treatment
* History of allogeneic tissue/solid organ transplant
* Active or history of autoimmune disease or immune deficiency
* Patient with symptomatic or actively progressing central nervous system (CNS) metastases, carcinomatous meningitis, or has been treated with whole brain radiation
* History of other cancer within 2 years with the exception of neoplasm that has undergone potentially curative therapy
* Any severe concurrent non-cancer disease that, in the judgment of the Investigator, would make the patient inappropriate for the current study
* Active tuberculosis or recent (<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV
* History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)
* Myocardial infarction within previous 3 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (Class III or IV).
* Pregnant, planning to become pregnant, or nursing.