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Trial record 3 of 5 for:    Oncos

A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03514836
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

Brief Summary:

This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or chemotherapy.

Male patients with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either All patients must have at least one readily accessible soft tissue/nodal tumor lesion (for intra-tumoral application of ONCOS-102 and biopsy.


Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Biological: DCVac/PCa Drug: Cyclophosphamide Phase 1 Phase 2

Detailed Description:

Study Description:

  • All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure.
  • ONCOS-102 administration will start within 3 weeks of leukapheresis at Week 5 (35 days since baseline +/- 2 days), and 3 further doses will be administered on a weekly basis
  • Cyclophosphamide A priming bolus dose of CPO (300 mg/m2 intravenously) will be given 1-3 days before the first (Week 5) and the fifth (Week 14) of ONCOS-102 administration.
  • DCVAC/PCa therapy will start 6 weeks after leukapheresis at Week 8. DCVAC/PCa will be administered subcutaneously in cycles, always on Day 1 (+/- 3 days) of the corresponding cycle.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label combination treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men With Advanced Metastatic Castration-resistant Prostate Cancer.
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: DCVac and ONCOS-102
ONCOS-102 is given intra-tumor up to 4 times, cyclophosphamide is given prior to the first dose of ONCOS-102 and at the fifth week of treatment DCVac is given sc every 21-28 days for up to 10 doses
Biological: DCVac/PCa
Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy
Other Name: ONCOS-102

Drug: Cyclophosphamide
immunomodulatory medication given around the ONCOS-102 dosing




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 96 months ]
    PFS measured by modifications to the RECIST 1.1. PFS is defined as the time from the first dose of SoC therapy administered to tumor progression or death from any cause.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 96 months ]
    Defined as the time from Baseline visit to the date of death for any cause

  2. Safety [ Time Frame: 96 months ]
    Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033

  3. Time to Progression-PSA [ Time Frame: 96 months ]
    demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2

  4. Radiographic Progression- free survival [ Time Frame: 96 months ]
    composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Radiographically documented metastatic disease with evidence of disease progression Laboratory parameters per protocol
  • Surgically or medically castrate
  • Patients who have progressed following:
  • a. at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or
  • b. one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or
  • c. failure of two lines of chemotherapy; or
  • d. failure of pre-chemotherapy abiraterone or enzalutamide and subsequent chemotherapy

Exclusion Criteria:

  • Patients with neuroendocrine or small cell cancer of the prostate 2. History of other malignant disease (with the exception of the primary prostate cancer and non-melanoma skin tumors) in the past 5 years Pre-defined co-morbidities
  • Administration of experimental therapy within the last 4 weeks before start of screening
  • Treatment with immunotherapy within the last 3 months before start of screening
  • Treatment with radiopharmaceutical drugs within 8 weeks before start of screening
  • Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start
  • History of organ transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514836


Contacts
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Contact: Richard Kapsa (+420) 2241 74448 kapsa@sotio.com

Locations
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Czechia
Fakultní nemocnice v Motole Recruiting
Praha, Czechia, 150 06
Sponsors and Collaborators
Sotio a.s.
Investigators
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Study Director: Inna Krasnopolskaya, MD Sotio as

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Responsible Party: Sotio a.s.
ClinicalTrials.gov Identifier: NCT03514836     History of Changes
Other Study ID Numbers: SP015
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sotio a.s.:
Castrate-resistant

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists