Buscador de ensayos clínicos

Comentarios

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.

Criterios de inclusión

Criterios de inclusión:

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.

Criterios de exclusión

Criterios de exclusión:

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.