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Solid Tumor, AdultPhase 1NCT05071846

MVX-ONCO-2 in Advanced Solid Tumors

A Phase 1 study testing MVX-ONCO-2 in people with Solid Tumor, Adult, run by University Hospital, Geneva at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
MVX-ONCO-2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSwitzerland
Study dates
22 Oct 2024to Oct 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 surgical harvest procedure for the assessment of tumor size throughout the study.
  • Must have a life expectancy estimate of at least 4 months.
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  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 1.
  • Must have no major impairment of liver function: Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of the normal range (ULN); bilirubin ≤ 1.5 × ULN. Exceptions:
  • Liver metastases: ALT ≤ 5 × ULN; bilirubin ≤ 3 × ULN;
  • Documented diagnosis of Gilbert syndrome: total bilirubin ≤ 3 × ULN.
  • Must have no major impairment of renal function: Estimated glomerular filtration rate (eGFR) > 30 mL/min as calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI).
  • Must have no major impairment of bone marrow function (without hematological support within 7 days prior to assessment): Hemoglobin ≥ 9.0 g/dL; complete blood count (CBC) ≥ 2.5 × 109/L; neutrophils ≥ 1.5 × 109/L; platelets ≥ 75 × 109/L.
  • Must have no major impairment of coagulation status: International normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulation therapy), prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ ULN.
  • May be male or female.
  • A male participant with a female partner of childbearing potential must agree to remain sexually abstinent or use condoms during the treatment period with MVX-ONCO-2 and for 60 days after the last treatment; and the patient must also refrain from donating sperm during this period.
  • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP). OR ii. A WOCBP who has had a negative pregnancy test within 7 days before the first study treatment and agrees to follow contraceptive guidance during the treatment period and for at least 60 days after the last dose of study treatment.
  • Has the ability to understand the concept of a clinical study and be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures.
  • Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this Protocol.
  • Patient or legal representative has signed an ICF prior to any study-specific procedures or treatment.

Who cannot join

  • Has participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 weeks before Screening.
  • Has received any prior cytotoxic biologic or any investigational agent treatment in the 4 weeks (or 5 half-lives, whichever is shorter) before Screening. Chronic treatment with non investigational gonadotropin-releasing hormone analogues or other hormonal or supportive care is permitted.
  • Has received prior radiotherapy within 2 weeks of the start of study treatment. Prior irradiation of RECIST 1.1 target lesions is not allowed.
  • Note: radiotherapy of bone metastases to control pain is allowed.
  • Has history of another malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
  • Note: The time requirement does not apply to patients who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.
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  • Has known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
  • Has known history of positive test for HIV-1 or HIV-2 unless on established anti-retroviral therapy (ART) for at least 4 weeks prior to treatment administration and whose viral load is ≤ 400 copies/mL prior to enrollment.
  • Has known history of hepatitis B virus (HBV). Patients who are hepatitis B surface antigen negative and HBV viral deoxyribonucleic acid (DNA) negative may be included in the study. Patients who had HBV but who received an antiviral treatment and show non-detectable viral DNA for 6 months or patients who are seropositive because of HBV vaccine may also be included in the study.
  • Has known history of hepatitis C virus (HCV). Patients who had HCV but who received an antiviral treatment and show no detectable HCV viral deoxyribonucleic acid (DNA) for 6 months may be included in the study.
  • Has known active or recent cytomegalovirus (CMV) infection.
  • Has received vaccine containing live virus within 4 weeks prior to the first dose of study treatment. Inactivated seasonal influenza vaccines are permitted on study without restriction.
  • Has a clinically severe auto-immune condition requiring immunosuppressive medication.
  • Has a history of transplants.
  • Has conditions requiring concurrent use of systemic immunosuppressants or corticosteroids > 30 mg daily of cortisone or equivalents. Topical steroids at or near the injection site should not be allowed.
  • Use of other immunosuppressive medications within 14 days of study treatment.
  • Has evidence of chronic or concurrent active infection or medical condition that requires intravenous antibacterial, antiviral, or antifungal therapy within 14 days of the first study treatment administration.
  • Has other unresolved toxicities related to prior anticancer therapy and/or surgery.
  • Note: Patient must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxic effects of prior therapy or surgical procedure (except alopecia).
  • Has uncontrolled or significant cardiovascular disease including, but not limited to, any one of the following:
  • Myocardial infarction ≤ 6 months prior to the first dose;
  • Unstable angina pectoris;
  • Uncontrolled congestive heart failure (New York Heart Association [NYHA] > Class II);
  • Uncontrolled ≥ Grade 3 hypertension (per the CTCAE); and
  • Uncontrolled cardiac arrhythmias.
  • Has any known or underlying medical or psychiatric condition, and/or social situations that, in the opinion of the Investigator, would limit participation and compliance with the study requirements.
  • Has a history of allergy or hypersensitivity to any of the study treatments or study treatment components.
  • Has received transfusions of blood products (including platelets or red blood cells), or the administration of colony-stimulatory factors (including G-CSF and GM-CSF), or recombinant erythropoietin within 4 weeks before the start of study treatment.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Hôpitaux Universitaires de Genève

    Geneva

Other trials in Switzerland

About this study

Official title: An Open Label, Single Arm, Phase I Clinical Study Assessing Safety, Tolerability, and Efficacy of MVX-ONCO-2 in Patients With Advanced Solid Tumors

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.

Being tested
MVX-ONCO-2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVX-ONCO-2Biological

    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.

Study groups in NCT05071846
Study groupRoleWhat they receive
MVX-ONCO-2ExperimentalImplantation of 2 capsules containing MVX-2 cells and 1 injection of 4 × 10^6 lethally irradiated autologous tumor cells
Receives: Biological: MVX-ONCO-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events and/or serious adverse events

    Safety parameters including, but not limited to, adverse events (AEs) and serious adverse events (SAEs) (incidence, causality, severity), changes in laboratory values, and vital signs.

    Measured: 6 months

Secondary outcomes (4)

  1. Tumor response

    Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 2 years

  2. Duration of response

    Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 2 years

  3. Progression-free survival

    Measured: Assessed up to 5 years

  4. Overall survival

    Measured: Assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2021
  2. Study start22 Oct 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05071846
Sponsor's protocol ID
MVX-2021-01
Status last verified
Apr 2026
First submitted
28 Sep 2021
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVX-ONCO-2 in people with Solid Tumor, Adult, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events and/or serious adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05071846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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