Clinical Trial Results:
T-cell therapy in combination with checkpoint inhibitors for patients with advanced ovarian-, fallopian tube- and primary peritoneal cancer.
Summary
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EudraCT number |
2017-002179-24 |
Trial protocol |
DK |
Global end of trial date |
02 Jun 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Jul 2020
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First version publication date |
03 Jul 2020
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Other versions |
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Summary report(s) |
Summary of results |
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 |
GY1721
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03287674 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
National Center for Cancer Immune Therapy (CCIT-DK)
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Sponsor organisation address |
Borgmester Ib Juuls Vej 25C, Herlev, Denmark, 2730
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Public contact |
National Center for Cancer Immune Therapy, National Center for Cancer Immune Therapy, 0045 38683868, anders.kverneland@regionh.dk
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Scientific contact |
National Center for Cancer Immune Therapy, National Center for Cancer Immune Therapy, 0045 4538683868, anders.kverneland@regionh.dk
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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 |
16 Jun 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jun 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Jun 2020
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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 |
To evaluate toxicity (according to CTCAE version 4.0) and feasibility.
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Protection of trial subjects |
All side effects were treated in accordance with best clinical practice.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2017
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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 |
Denmark: 6
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Worldwide total number of subjects |
6
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EEA total number of subjects |
6
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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) |
6
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients were recruited from Danish oncology centers between 2017-2018. | ||||||||||||
Pre-assignment
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Screening details |
Patients eligible for therapy were screening at Herlev Hospital according to in- and exclusion criteria described in the protocol. | ||||||||||||
Period 1
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Period 1 title |
Treatment time (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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Arm title
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TILs and checkpoint inhibition | ||||||||||||
Arm description |
Ipilimumab, Cyclophosphamide, Fludarabine, TILs, Nivolumab, IL-2 | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
cyclophosphamide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
60 mg/kg daily for 2 days. Day -7 and -6 before TIL infusion
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Investigational medicinal product name |
Ipilimumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
3 mg/kg once, 2 weeks before tumor removal
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Investigational medicinal product name |
Fludarabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
25 mg/m2 daily (max 50 mg) for 5 days. At day -5 to -1 before TIL infusion
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Investigational medicinal product name |
Tumor infiltrating lymphocytes
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Investigational medicinal product code |
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Other name |
TILs, REP-TILs
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Pharmaceutical forms |
Concentrate for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Typically 25-100 billion autologous T-cells expanded ex vivo from patients's own metastasis
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Investigational medicinal product name |
Interleukin-2
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Investigational medicinal product code |
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Other name |
IL-2, aldesleukin
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Pharmaceutical forms |
Concentrate and solvent for suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
2 MIE daily for 14 days. Starting at day +1 after TIL infusion
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Investigational medicinal product name |
Nivolumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
3 mg/kg every 14 days until 4 doses. Starting on day -2 before TILs.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment time
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
TILs and checkpoint inhibition
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Reporting group description |
Ipilimumab, Cyclophosphamide, Fludarabine, TILs, Nivolumab, IL-2 |
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End point title |
Feasibility [1] | ||||||||||
End point description |
Succcesful ex vivo expansion and re-infused into the patient
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End point type |
Primary
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End point timeframe |
Oct-2017 to july 2018
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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: The clinical trial is very small with only 6 participants. No consideration was given to statistical power. Statistical analyses involve non-parametric comparisons. |
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No statistical analyses for this end point |
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End point title |
Overall response rate | ||||||||||||||
End point description |
Best overall response according to RECIST 1.1.
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End point type |
Secondary
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End point timeframe |
3-9 months after TIL infusion
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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 |
from recruitment to discontinuation from protocol
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Adverse event reporting additional description |
CTCAE 4.0.
Non-serious event are only reported if grade>2
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
TIL treated group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 |