MVX-ONCO-1 in Patients With Solid Tumor

NCT02193503 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MVX-2011-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.

Conditions

Solid Tumor; Cancer

Keywords

cancer; solid tumors; gene therapy; cell therapy; encapsulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Delayed type hypersensitivity reactions, Induction of a specific CD8 response

  18 weeks

• imaging and metabolic monitoring

  18 weeks

• tumor size

  18 weeks

• tumor pain

  18 weeks

Study Arms (1)

treatment

EXPERIMENTAL

MVX-1-loaded capsules and injection of irradiated autologous tumor cells

Other: Treatment

Interventions

Treatment OTHER

Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells

Also known as: - capsules MVX-1-loaded (medical device), - irradiated autologous tumor cells (cell therapy)

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxivax SA: lead

Study Sites (1)

Hopitaux Universitaires de Genève - HUG

Geneva, Canton of Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Therapeutics; Equipment and Supplies; Cell- and Tissue-Based Therapy

Intervention Hierarchy (Ancestors)

Biological Therapy

Study Officials

• Eugenio Fernandez, MD

  HUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: July 17, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CH (1)