Status:
ACTIVE_NOT_RECRUITING
MVX-ONCO-1 in Patients With Solid Tumor
Lead Sponsor:
Maxivax SA
Conditions:
Solid Tumor
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 so...
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, change...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02193503
Start Date
March 1 2014
End Date
December 1 2026
Last Update
September 28 2023
Active Locations (1)
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1
Hopitaux Universitaires de Genève - HUG
Geneva, Canton of Geneva, Switzerland, 1205