MVX-ONCO-1 in Patients With Solid Tumor

Sponsor

Maxivax SA (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02193503

Collaborator

(none)

Enrollment

Location

Arm

153

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Cancer	Other: Treatment	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Number of patients with Adverse Events and/or Serious Adverse Events [18 weeks]
Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity.

Secondary Outcome Measures

Delayed type hypersensitivity reactions, Induction of a specific CD8 response [18 weeks]
immune monitoring
imaging and metabolic monitoring [18 weeks]
tumor size [18 weeks]
document of tumor number, sites, size of lesions
tumor pain [18 weeks]
intensity, site, frequency of pain, use of analgesics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.