MVX-ONCO-1 in Patients With Solid Tumor
September 27, 2023 updated by: Maxivax SA
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Genève
-
Geneva, Genève, Switzerland, 1205
- Hôpitaux Universitaires de Genève - HUG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: treatment
MVX-1-loaded capsules and injection of irradiated autologous tumor cells
|
Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed type hypersensitivity reactions, Induction of a specific CD8 response
Time Frame: 18 weeks
|
immune monitoring
|
18 weeks
|
|
imaging and metabolic monitoring
Time Frame: 18 weeks
|
18 weeks
|
|
|
tumor size
Time Frame: 18 weeks
|
document of tumor number, sites, size of lesions
|
18 weeks
|
|
tumor pain
Time Frame: 18 weeks
|
intensity, site, frequency of pain, use of analgesics
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eugenio Fernandez, MD, HUG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2014
Primary Completion (Actual)
March 1, 2022
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 26, 2013
First Submitted That Met QC Criteria
July 15, 2014
First Posted (Estimated)
July 17, 2014
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MVX-2011-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.