Trial Parameters
Brief Summary
MVX-ONCO-2 is a patient-specific, cell-based, active immunotherapy where the participant's immune response to their own tumor cells is stimulated and/or increased. MVX-ONCO-2 is composed of a cell suspension of irradiated autologous tumor cells and two capsules loaded with allogenic genetically modified cells releasing an immunomodulator, granulocyte-macrophage colony stimulating factor (GM-CSF). MVX-ONCO-2 is an evolution of MVX-ONCO-1, which was approved for clinical investigation under the same category in a phase I and a phase II clinical trials. The objectives of the trial are to investigate the safety, tolerability and signals of efficacy of MVX-ONCO-2 in participants with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: * Patient with advanced metastatic solid tumors with documented tumor progression after at least one line of systemic therapy and for which no further standard therapies are available, feasible or accepted by the patient. Prior exposure to an immune checkpoint inhibitor (ICPI) is allowed. Patient with a localized disease for which no curative therapy is available and a measurable lesion is still amenable for RECIST assessment after biopsy (to manufacture the vaccine) are allowed (example: GBM or sarcoma with local relapse after surgery, chemo-radiation) * Must be 18 years of age or older at the time of signing the informed consent. * Must have a primary tumor and/or metastasis amenable for surgery (or tap as indicated). * Must be willing to undergo a surgical tumor biopsy (or tap as indicated) prior to registration. * Must have at least 1 additional radiologically measurable lesion of the primary cancer type, evaluable per RECIST 1.1, that will remain untouched by s