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A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma

Brief Summary

The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30 patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a non-randomised safety phase and a randomised phase. The safety phase will consist of a lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised phase will not commence until the DSMB has deemed the safety lead-in data appropriate for continuation. A total of 24 patients will be included in the randomised phase; 14 patients will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will receive pemetrexed/cisplatin alone. The trial's main objectives are determination of safety, immune activation, clinical response and the correlation between clinical outcome and the immunological data.

Tracking Information
First Received DateJuly 13, 2016
Last Changed DateFebruary 9, 2017
Start DateJune 2016
Anticipated Primary Completion DateDecember 2018
Primary Outcome Measures

Number of patients with any (Serious and Non-Serious) Adverse Event measured to assess safety and tolerability [Time Frame: 6 months]

Secondary Outcome Measures

To determine and compare tumour-specific immunological activation in the peripheral blood in the experimental group and the control group. Number of patients in the respective arms with induction of Tumor specific CD8+ T Cells in PBMC [Time Frame: 6 months]

To determine and compare immunological activation in tumour mass in the experimental group and the control Group. Number of patients in the respective arms with infiltration of CD8+ T Cells into tumours [Time Frame: 6 months]

To determine and compare overall response rate in the experimental group and the control group by number of patients with PD, SD, PR and CR in the respective arms [Time Frame: 6 months]

To determine and compare progression-free survival (PFS) in the experimental group and the control group by median time to progression in the respective arms [Time Frame: 6 months]

To determine and compare overall survival (OS) in the experimental group and the control group [Time Frame: Until death]

To analyse immunological activation by comparing patients with and without presence of tumour antigen recognizing CD8+ T cells [Time Frame: 6 months]

To analyse clinical outcome by time to event endpoints (OS and PFS) [Time Frame: 6 months]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • To Determine Safety, Tolerability and Efficacy of ONCOS-102 in Combination With Chemotherapy
Intervention
  • Biological: ONCOS-102
  • Drug: Pemetrexed/cisplatin
  • Drug: Cyclophosphamide
Study Arms / Comparison Groups2 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment30
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Tiina Hakonen, MSc
Email: tiina.hakonen@targovax.com
Phone: +358409000120
Eligibility Criteria

Inclusion Criteria:

- Written informed consent.

- Male or female, ≥18 years of age.

- 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.

- This includes patients who are naïve to chemotherapy,

- and those who have already received pemetrexed/cisplatin to which their tumour initially responded, but they have relapsed after at least 6 months.

- Measurable disease according to Response Evaluation in Solid Tumour (RECIST) 1.1.

- Tumour must be accessible to intratumoural (i.t.) injections and to tumour core needle biopsy or thoracoscopy for tissue sampling and immunohistochemistry analysis.

- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance score 0 to 1.

- Acceptable liver, renal, and haematological functions.

- 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.

Exclusion Criteria:

- Receipt of oncolytic virus treatment, or vaccination with a vaccine containing live virus within 4 weeks before Day 1.

- Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of >10 mg/day prednisone) within 4 weeks before Day 1.

- Patients who participated in a study with an investigational drug or device within 4 weeks prior to Day 1.

- Active bacterial, viral, or fungal infections, requiring systemic therapy.

- Severe arrhythmia, heart failure, previous cardiac infarction, or acute inflammatory heart disease.

- 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.

- Known infection with HIV, hepatitis B, or hepatitis C.

- Known brain metastases.

- History of organ transplant.

- Females who are pregnant or breast feeding.

- Unwillingness or inability to comply with the study protocol for any reason.

- Patients with pre-existing hearing loss or neuropathy that may worsen due to potential neurotoxicity from cisplatin.

- Patients with a history of hypersensitivity to cisplatin or pemetrexed or cyclophosphamide (or any of its metabolites).

- Patients who are taking phenytoin for prophylactic use.

- 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.

Administrative Information
NCTIDNCT02879669
Responsible Party,
SponsorTargovax Oy
Verification DateDecember 2016
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  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

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