Patients with unresectable malignant pleural mesothelioma MedDRA version: 18.1 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 100000004864
Conditions
Interventions
Product Name: ONCOS-102
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: ONCOS-102
Current Sponsor code: ONCOS-102
Concentration unit: billion organisms/ml billion orga
Sponsors
Targovax Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.? Written informed consent. 2.? Male or female, ?18 years of age. 3.? Histologically confirmed unresectable (advanced) malignant pleural mesothelioma in patients who are not candidates for curative surgery and for whom therapy with pemetrexed/cisplatin is considered appropriate. o This includes patients who are naïve to chemotherapy, o and those who have already received pemetrexed/cisplatin to which their tumour initially responded, but they have relapsed after at least 6 months. 4.? Measurable disease according to Response Evaluation in Solid Tumour (RECIST) 1.1. 5.? Tumour must be accessible to intratumoural (i.t.) injections and to tumour core needle biopsy or thoracoscopy for tissue sampling and immunohistochemistry analysis. 6.? Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance score 0 to 1. 7.? Acceptable liver, renal, and haematological functions. 8.? All women of childbearing potential must have a negative urine or serum pregnancy test at screening and all patients must agree to use barrier contraception (i.e. condom) during study treatment and for 2 months after the last virus treatment and 6 months after the last dose of pemetrexed/cisplatin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Receipt of oncolytic virus treatment, or vaccination with a vaccine containing live virus within 4 weeks before Day 1. 2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of >10 mg/day prednisone) within 4 weeks before Day 1. 3. Patients who participated in a study with an investigational drug or device within 4 weeks prior to Day 1. 4. Active bacterial, viral, or fungal infections, requiring systemic therapy. 5. Severe arrhythmia, heart failure, previous cardiac infarction, or acute inflammatory heart disease. 6. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study. 7. Known infection with HIV, hepatitis B, or hepatitis C. 8. Known brain metastases. 9. History of organ transplant. 10. Females who are pregnant or breast feeding. 11. Unwillingness or inability to comply with the study protocol for any reason. 12. Patients with pre-existing hearing loss or neuropathy that may worsen due to potential neurotoxicity from cisplatin. 13. Patients with a history of hypersensitivity to cisplatin or pemetrexed or cyclophosphamide (or any of its metabolites). 14. Patients who are taking phenytoin for prophylactic use. 15. History of malignant tumour, unless the patient has been without evidence of disease for at least 3 years, or the tumour was a non-melanoma skin tumour, cervical carcinoma in situ, or prostatic carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of ONCOS-102 in combination with pemetrexed/cisplatin.;Secondary Objective: ? To determine and compare tumour-specific immunological activation in the peripheral blood in the experimental group (ONCOS 102 in combination with pemetrexed/cisplatin) and the control group (pemetrexed/cisplatin). ? To determine and compare immunological activation in tumour mass in the experimental group and the control group. ? To determine and compare overall response rate and progression-free survival (PFS) in the experimental group and the control group. ? To determine and compare overall survival (OS) in the experimental group and the control group. ? To analyse the correlation between immunological activation and clinical outcome.;Primary end point(s): Safety and tolerability profile of ONCOS 102 and pemetrexed/cisplatin after 2 cycles of chemotherapy (Day 64).;Timepoint(s) of evaluation of this end point: This will be assessed in an ongoing basis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Biological correlates by means of cellular and humoral immune responses in blood as well as biological changes in tumour biopsies of injected and non-injected tumours. ? Response rate and PFS according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, modified immunologically relevant RECIST (iRECIST ) and PERCIST 1.0 PET criteria (PERCIST). ? Overall survival.;Timepoint(s) of evaluation of this end point: Points 1 and 2 will be done on an ongoing basis Third point ? will continue until the last treated patient has died. | — |
Countries
France, Germany, Spain, United Kingdom
Contacts
Public ContactCharlotta Backman
Targovax Ltd.
Outcome results
None listed