MVX-ONCO-1 in Patients With Solid Tumor

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: Cancer; Solid Tumor
• Intervention / Treatment: Other: 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

Study Locations

• Switzerland
  • Genève
    • Geneva, Genève, Switzerland, 1205
      • Hopitaux Universitaires de Geneve - HUG

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; MVX-1-loaded capsules and injection of irradiated autologous tumor cells	Other: Treatment; Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells; Other Names: - capsules MVX-1-loaded (medical device); - irradiated autologous tumor cells (cell therapy)

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	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	immune monitoring	18 weeks
imaging and metabolic monitoring		18 weeks
tumor size	document of tumor number, sites, size of lesions	18 weeks
tumor pain	intensity, site, frequency of pain, use of analgesics	18 weeks

Collaborators and Investigators

• Sponsor: Maxivax SA
• Investigators: Principal Investigator: Eugenio Fernandez, MD, HUG

Study record dates

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

• Keywords: cancer; gene therapy; cell therapy; solid tumors; encapsulation
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MVX-2011-01