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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Castration-resistant Prostate Cancer
• Intervention / Treatment: Biological: DCVac/PCa; Drug: Cyclophosphamide

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 150 06
    • Fakultni nemocnice v Motole

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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. DCVac/Pca consists of activated autologous dendritic cells. This is an experimental therapy.; Other Names: ONCOS-102; Drug: Cyclophosphamide; immunomodulatory medication given around the ONCOS-102 dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	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.	96 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Defined as the time from Baseline visit to the date of death for any cause	96 months
Safety	Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033	96 months
Time to Progression-PSA	demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2	96 months
Radiographic Progression- free survival	composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause	96 months

Collaborators and Investigators

• Sponsor: SOTIO a.s.
• Investigators: Study Director: Roman Korolkiewicz, MD, PhD, Sotio as

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2018
• Primary Completion (ACTUAL): January 25, 2021
• Study Completion (ACTUAL): January 25, 2021

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (ACTUAL): May 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Castrate-resistant
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide
• Other Study ID Numbers: SP015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No