MVX-ONCO-1 in Patients With Solid Tumor
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ClinicalTrials.gov Identifier: NCT02193503 |
Recruitment Status :
Active, not recruiting
First Posted : July 17, 2014
Last Update Posted : January 27, 2022
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Cancer | Other: Treatment | Phase 1 |
Endpoints:
Primary: To assess safety parameters including adverse and serious adverse events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with solid tumor; Secondary: to measure some tumor responses in using imaging technique, serological tumor markers, immune monitoring and metabolic monitoring.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Phase I Clinical Study Assessing Safety and Tolerability of MVX-ONCO-1 in Patients With Solid Tumor Who Are Not/Not Any Longer Amenable to Standard Therapy |
Actual Study Start Date : | March 2014 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
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Experimental: treatment
MVX-1-loaded capsules and injection of irradiated autologous tumor cells
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Other: Treatment
Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
Other Names:
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- Number of patients with Adverse Events and/or Serious Adverse Events [ Time Frame: 18 weeks ]Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity.
- Delayed type hypersensitivity reactions, Induction of a specific CD8 response [ Time Frame: 18 weeks ]immune monitoring
- imaging and metabolic monitoring [ Time Frame: 18 weeks ]
- tumor size [ Time Frame: 18 weeks ]document of tumor number, sites, size of lesions
- tumor pain [ Time Frame: 18 weeks ]intensity, site, frequency of pain, use of analgesics

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients aged 18 years and older with advanced metastatic cancer in progression of various sites [Carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head&neck, thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); Sarcoma of soft tissue, bone, uterus, melanoma; primary brain tumor] where all recognized treatment are exhausted or not feasible.
- Life expectancy: estimate of at least 4 months.
Exclusion Criteria:
- Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks.
- Have received any chemotherapy treatment in the 4 preceding weeks.
- Serious concomitant health condition such as organ transplant requiring immunosuppressive drugs, severe psychiatric disorders.
- History of second cancer within the last 2 years with the exception of basal cell carcinoma of skin and localized cervical carcinoma treated with curative intent.
- Patient with a systemic disease other than cancer, that is not controlled by usual medication.
- Therapeutic anticoagulation with coumarine or continues iv heparin. Low-molecular weight heparin (LMWH) is permitted as long as treatment can be withheld several hours prior to subcutaneous implantation.
- Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C antibody.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193503
Switzerland | |
Hopitaux Universitaires de Genève - HUG | |
Geneva, Genève, Switzerland, 1205 |
Principal Investigator: | Eugenio Fernandez, MD | HUG |
Responsible Party: | Maxivax SA |
ClinicalTrials.gov Identifier: | NCT02193503 |
Other Study ID Numbers: |
MVX-2011-01 |
First Posted: | July 17, 2014 Key Record Dates |
Last Update Posted: | January 27, 2022 |
Last Verified: | January 2022 |
cancer solid tumors gene therapy cell therapy encapsulation |
Neoplasms |