MVX-ONCO-1 in Patients With Solid Tumor

Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02193503
• Other study ID #: MVX-2011-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 2014
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Maxivax SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: December 2026
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
Switzerland	Hopitaux Universitaires de Genève - HUG	Geneva	Genève

Sponsors (1)

Lead Sponsor	Collaborator
Maxivax SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Delayed type hypersensitivity reactions, Induction of a specific CD8 response	immune monitoring	18 weeks
Secondary	imaging and metabolic monitoring		18 weeks
Secondary	tumor size	document of tumor number, sites, size of lesions	18 weeks
Secondary	tumor pain	intensity, site, frequency of pain, use of analgesics	18 weeks