Clinical Trial Results:
Open-label, one-arm, multi-centre phase II clinical trial with second cycle of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy and without objective progression on the first cycle of DCVAC/PCa
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Summary
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EudraCT number |
2013-003809-26 |
Trial protocol |
CZ |
Global end of trial date |
20 Mar 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Apr 2018
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First version publication date |
01 Apr 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SP010
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02137746 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Sotio a.s.
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Sponsor organisation address |
Jankovcova 1518/2, Prague, Czech Republic, 170 00
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Public contact |
Clinical Trials Sotio, SOTIO a.s., +420 224175111, clinicaltrial@sotio.com
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Scientific contact |
Clinical Trials Sotio, SOTIO a.s., +420 224175111, clinicaltrial@sotio.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Mar 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Mar 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Mar 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objective of the study SP010 was to establish the safety profile of extended application of active cellular immunotherapy prepared from repeated leukapheresis. The safety of the second cycle of active cellular immunotherapy involving the second leukapheresis procedure was to be assessed in patients who successfully received all doses of active cellular immunotherapy after RPE or salvage radiotherapy and who were without objective progression of the disease during the study SP003. Other objectives were to evaluate prostate-specific antigen (PSA) doubling time (DT) in the treatment phase of the study SP010 and to compare it with PSADT in the study SP003; to evaluate PSADT in the follow-up phase of the study SP010; to determine the proportion of patients who had progressive increase in PSA, objective disease progression, or further anticancer therapy within 2 years of enrollment; and to evaluate overall survival (OS).
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Protection of trial subjects |
Not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Dec 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Czech Republic: 23
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Worldwide total number of subjects |
23
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EEA total number of subjects |
23
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
9
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From 65 to 84 years |
14
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85 years and over |
0
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Recruitment
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Recruitment details |
Eight clinical study centers in the Czech Republic participated in the study SP010 and all recruited (screened) at least 1 patient. Recruitment started on 17-Dec-2013 (first patient signed the informed consent form) and ended on 02-Apr-2015 (last patient signed the informed consent form). | ||||||
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Pre-assignment
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Screening details |
Screened: 24 Enrolled: 23 Analyzed for efficacy: 23 Analyzed for safety: 23 | ||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Immunotherapy group | ||||||
Arm description |
DCVAC/PCa | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Overall trial (overall period)
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Investigational medicinal product code |
Not applicable
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Other name |
Not applicable
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Pharmaceutical forms |
Dispersion for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subcutaneous injection of approximately 1×10e7 autologous DCs
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Immunotherapy group
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Reporting group description |
DCVAC/PCa | ||
Subject analysis set title |
ITT-derived populations
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
The ITT population consisted of all enrolled patients except those for whom no data were available following the baseline visit. For endpoints where PSADT was the main interest, only patients who had 2 or more PSA values in the examined time period were taken into consideration. It means that for the treatment phase, the ITT population with 2 or more PSA values in the treatment phase (ITT2t) was examined. The same applied to the follow-up phase with the population ITT2f.
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End point title |
Incidence of AEs, SAEs, clinically significant laboratory abnormalities, and changes in vital signs [1] | ||||||
End point description |
Please see the sention on adverse events
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End point type |
Primary
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End point timeframe |
Duration of the study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal analysis was done for the primary end point of this single-arm study. See also the section on adverse events. |
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| No statistical analyses for this end point | |||||||
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End point title |
PSADT in the treatment phase | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From Dose 1 to Dose 10
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| Notes [2] - ITT2t |
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| No statistical analyses for this end point | |||||||||
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End point title |
Comparing PSADT measured in the treatment phase of the study SP010 with PSADT measured in the study SP003 | ||||||||
End point description |
Differences between PSADT in the study SP003 and PSADT in the study SP010
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End point type |
Secondary
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End point timeframe |
Treatment phase of the studies SP003 and SP010
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| Notes [3] - ITT2t |
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| No statistical analyses for this end point | |||||||||
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End point title |
PSADT in the follow-up phase | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From the completed V10 to 2 years from enrollment in the study
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| Notes [4] - ITT2f |
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| No statistical analyses for this end point | |||||||||
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End point title |
Comparing PSADT measured in the follow-up phase with PSADT in the treatment phase | ||||||||
End point description |
Differences between PSADT in the treatment phase and PSADT in the follow-up phase
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End point type |
Secondary
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End point timeframe |
From V1 to 2 years from enrollment in the study
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| Notes [5] - ITT2f |
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| No statistical analyses for this end point | |||||||||
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End point title |
Proportion of patients who required any further anticancer therapy | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within 2 years from enrollment in the study
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| Notes [6] - ITT |
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| No statistical analyses for this end point | |||||||||
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End point title |
Proportion of patients who had progressive increase in PSA | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within 2 years from enrollment in the study
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| Notes [7] - ITT |
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| No statistical analyses for this end point | |||||||||
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End point title |
Overall survival | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
2 years after enrollment
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| Notes [8] - ITT |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatment-emergent AEs and SAEs: from V1 to 30 days after the last dose of DCVAC/PCa
Deaths: from consent signature to trial termination
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Adverse event reporting additional description |
The tables include information on treatment-emergent AEs and treatment-emergent SAEs. An event causally related to treatment was one which was assessed by investigators as causally related to DCVAC/PCa administration.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Immunotherapy group
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Reporting group description |
DCVAC/PCa | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 Nov 2013 |
- Update of the study schedule |
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07 Apr 2015 |
- Detailed description of exploratory objectives, endpoints, and analysis
- Detailed description of laboratory testing, including samples for research
- Alignment of inclusion and exclusion criteria and study objectives with the updated SP003 Protocol v. 5.0 dated 15-Aug-2014.
- Statistical analysis section updated
- Information about phase I/II clinical trials conducted by the University Hospital in Motol updated per current knowledge
- Section on concomitant medication updated
- Updated safety reporting sections, including the transfer of safety monitoring responsibilities from the European Pharminvent Services to SOTIO a.s.
- Introduction of new terminology: EoT, End of study, EoS visit, follow-up, and data follow-up after the EoS examinations visit
- Update of the duration of the clinical trial and of the number of patients enrolled into the clinical trial
- Updated section “Rationale for prostate cancer immunotherapy”
- Terminology harmonization |
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23 Jul 2015 |
- Corrected mistake in section 6.7.5 “End of Treatment (EoT)” concerning testosterone levels per “Dear Investigator Letter” dated 19-Jun-2015
- Implementation of minor wording updates in the PV section
- Clarification of the CT/bone scintigraphy schedule
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
