Clinical Trial Results:
Estudio fase II con inmunoterapia mediante células dendríticas e Hiltonol en pacientes con tumores sólidos.
Summary
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EudraCT number |
2010-023139-40 |
Trial protocol |
ES |
Global end of trial date |
19 May 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jan 2022
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First version publication date |
11 Jan 2022
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Other versions |
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 |
CD-2010-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01734564 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Clinica Universidad de Navarra
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Sponsor organisation address |
AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
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Public contact |
UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
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Scientific contact |
UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
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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 |
31 May 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 May 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
19 May 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Tumor response rate assessed by RECIST criteria
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Mar 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 |
Spain: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
10
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
It is intended to include patients with advanced solid tumors without conventional treatment. The study has two cohorts. In one of them, treatment with only dendritic cells and Hiltonol will be administered and in the second treatment with radiotherapy will be added. | |||||||||
Pre-assignment
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Screening details |
17 subjects are included of which 15 complete the study and 2 are screening failures. In the first cohort, 10 patients were included, of which 1 was a screening failure. In the second cohort, 7 patients were included, of which 1 was a screening failure. | |||||||||
Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cohort 1 | |||||||||
Arm description |
Hiltonol and autologous dendritic cells | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Autologous dendritic cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
The expected dose of dendritic cells is 5-10x10E6, resuspended in 0.5-1 ml of physiological saline. If there are not enough cells to complete the treatment, those that are available will be administered, reducing the dose or the number of injections.
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Investigational medicinal product name |
Hiltonol
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Investigational medicinal product code |
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Other name |
poly-ICLC
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Pharmaceutical forms |
Injection
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Routes of administration |
Intratumoral use
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Dosage and administration details |
Patients will receive 2 doses of Hiltonol 0.25 mg by intratumoral injection.
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Arm title
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Cohort 2 | |||||||||
Arm description |
Hiltonol, dendritic cells and radiation | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Autologous dendritic cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
The expected dose of dendritic cells is 5-10x10E6, resuspended in 0.5-1 ml of physiological saline. If there are not enough cells to complete the treatment, those that are available will be administered, reducing the dose or the number of injections.
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Investigational medicinal product name |
Hiltonol
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Investigational medicinal product code |
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Other name |
poly-ICLC
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Pharmaceutical forms |
Injection
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Routes of administration |
Intratumoral use
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Dosage and administration details |
Patients will receive 2 doses of Hiltonol 0.25 mg by intratumoral injection.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment period
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cohort 1
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Reporting group description |
Hiltonol and autologous dendritic cells | ||
Reporting group title |
Cohort 2
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Reporting group description |
Hiltonol, dendritic cells and radiation |
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End point title |
Response rate [1] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
8-10 weeks
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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: It is primarily a descriptive statistic. |
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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 |
During treatment.
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Adverse event reporting additional description |
The incidence of all treatment-related adverse events is presented.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Cohort 1
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Reporting group description |
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Reporting group title |
Cohort 2
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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03 Jul 2013 |
New version of IMPD file 09-033. |
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05 Feb 2015 |
New cohort associating radiotherapy with treatment with dendritic cells and hiltonol. |
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04 Feb 2016 |
The possibility of performing tumor biopsies, for research purposes, during the trial treatment is added.
The radiotherapy administration scheme is optimized.
Errata are corrected in the protocol. |
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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 |