Solid TumorPhase 1NCT02193503
MVX-ONCO-1 in Patients With Solid Tumor
A Phase 1 study testing Treatment in people with Solid Tumor and Cancer, run by Maxivax SA at 1 site in Switzerland.
Trial summary
The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Cancer
- What is being tested?
- Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Dec 2026
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hopitaux Universitaires de Genève - HUG
Geneva, Canton of Geneva, 1205
About this study
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
The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.
Read the detailed description
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.
- Conditions
- Solid Tumor, Cancer
- Being tested
- Treatment
- Keywords
- cancer, solid tumors, gene therapy, cell therapy, encapsulation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Also called - capsules MVX-1-loaded (medical device), - irradiated autologous tumor cells (cell therapy)
Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | MVX-1-loaded capsules and injection of irradiated autologous tumor cells Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Events and/or Serious Adverse Events
Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity.
Measured: 18 weeks
Secondary outcomes (4)
Delayed type hypersensitivity reactions, Induction of a specific CD8 response
immune monitoring
Measured: 18 weeks
imaging and metabolic monitoring
Measured: 18 weeks
tumor size
document of tumor number, sites, size of lesions
Measured: 18 weeks
tumor pain
intensity, site, frequency of pain, use of analgesics
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxivax SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugenio Fernandez, MD, Principal investigator, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193503
- Sponsor's protocol ID
- MVX-2011-01
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2013
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02193503
- Acronym / sponsor ID
- MVX-2011-01
- Conditions
- Solid Tumor, Cancer
- Keywords
- cancer, solid tumors, gene therapy, cell therapy, encapsulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Maxivax SAIndustry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Other: TreatmentMVX-1-loaded capsules and injection of irradiated autologous tumor cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentAlso: - capsules MVX-1-loaded (medical device), - irradiated autologous tumor cells (cell therapy)Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells | Other | treatment |
Primary outcome
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.
4 secondary outcomes
Delayed type hypersensitivity reactions, Induction of a specific CD8 response
Time frame: 18 weeks
imaging and metabolic monitoring
Time frame: 18 weeks
tumor size
Time frame: 18 weeks
tumor pain
Time frame: 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenio Fernandez, MD principal investigator
HUG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment in people with Solid Tumor and Cancer, run by Maxivax SA 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 2 inclusion and 7 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 28 Sep 2023. 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 patients with Adverse Events and/or Serious Adverse Events (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.