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MVX-ONCO-2 in Advanced Solid Tumors

NCT05071846 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

MVX-ONCO-2

One administration of MVX-ONCO-2 (or vaccination) consists of the implantation of 2 capsules containing MVX-2 cells and 1 injection of 4 × 10\^6 lethally irradiated autologous tumor cells. Tumor cells will have prealably been harvested from the participant through a surgical procedure. A full treatment course with MVX-ONCO-2 consists of a total of 6 vaccinations: 4 vaccinations 1 week apart, followed by 2 boosters 2 weeks apart. Capsules are removed 1 week after implantation.

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Eugenio Fernandez · University Hospital, Geneva

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2026-11-30
Completion
2029-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05071846 on ClinicalTrials.gov