Clinical Trial Results:
Nivolumab, ipilimumab and radiation in combination with influenza vaccine in patients with pancreatic cancer.
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Summary
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EudraCT number |
2021-003931-27 |
Trial protocol |
DK |
Global end of trial date |
19 Oct 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Sep 2024
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First version publication date |
25 Sep 2024
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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 |
GI2118
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05116917 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Department of Oncology, Herlev & Gentofte Hospital
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Sponsor organisation address |
Borgmester Ib Juuls Vej 1, Herlev, Denmark, 2730
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Public contact |
Principal Investigator Inna Chen, Department of Oncology, Herlev & Gentofte Hospital, +45 38682898, inna.chen@regionh.dk
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Scientific contact |
Principal Investigator Inna Chen, Department of Oncology, Herlev & Gentofte Hospital, +45 38682898, inna.chen@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 |
09 Apr 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Oct 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Oct 2023
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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 assess the efficacy of nivolumab, ipilimumab and radiation in combination with influenza vaccine in terms of objective response rate (ORR).
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Protection of trial subjects |
Patients that signed informed consent and fulfilling eligibility criteria were included. Continued monitoring of standard safety parameters during treatment.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Nov 2021
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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: 19
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Worldwide total number of subjects |
19
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EEA total number of subjects |
19
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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 |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
The trial was open for recruitment of patients from November 2021 to May 2023. All patients are recruited at a single site: Copenhagen University Hospital - Herlev and Gentofte in Denmark. Trial is prematurely ended due to lack of efficacy at preplanned interim analysis. | ||||||||||||
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Pre-assignment
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Screening details |
Eligible patients were ≥ 18 years with advanced pancreatic cancer with PD after at least one line of treatment, ECOG PS 0-1, adequate organ and hematologic function. | ||||||||||||
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Period 1
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Period 1 title |
INFLUENCE Treatment (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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Nivo/Ipi + SBRT and influenza vaccine | ||||||||||||
Arm description |
SBRT of 15 Gy will be given on day 1 of the first cycle. Nivolumab 3 mg/kg (up to 240 mg maximum) will be given on day 1 (± 3 days) of each 14-day treatment cycle until the progression of disease or maximum of 48 weeks, discontinuation due to toxicity, withdrawal of consent. Ipilimumab 1 mg/kg will be given on day 1 cycle 1 (± 3 days) and once more after 6 weeks. | ||||||||||||
Arm type |
Experimental | ||||||||||||
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 for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Nivolumab 3 mg/kg (up to 240 mg maximum) given on day 1 (± 3 days) of each 14-day treatment cycle until the progression of disease or maximum of 48 weeks, discontinuation due to toxicity, withdrawal of consent.
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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 for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Ipilimumab 1 mg/kg given on day 1 cycle 1 (± 3 days) and once more after 6 weeks.
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Investigational medicinal product name |
Seasonal quadrivalent influenza vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled injector
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Seasonal influenza vaccine is given IM or via PharmaJet Stratis Needle-Free Injection System, 0.5 mL per dose as a single on day 1 cycle 1
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Baseline characteristics reporting groups
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Reporting group title |
Nivo/Ipi + SBRT and influenza vaccine
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Reporting group description |
SBRT of 15 Gy will be given on day 1 of the first cycle. Nivolumab 3 mg/kg (up to 240 mg maximum) will be given on day 1 (± 3 days) of each 14-day treatment cycle until the progression of disease or maximum of 48 weeks, discontinuation due to toxicity, withdrawal of consent. Ipilimumab 1 mg/kg will be given on day 1 cycle 1 (± 3 days) and once more after 6 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Nivo/Ipi + SBRT and influenza vaccine
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Reporting group description |
SBRT of 15 Gy will be given on day 1 of the first cycle. Nivolumab 3 mg/kg (up to 240 mg maximum) will be given on day 1 (± 3 days) of each 14-day treatment cycle until the progression of disease or maximum of 48 weeks, discontinuation due to toxicity, withdrawal of consent. Ipilimumab 1 mg/kg will be given on day 1 cycle 1 (± 3 days) and once more after 6 weeks. | ||
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End point title |
Objective Response Rate [1] | ||||||||
End point description |
The primary endpoint of ORR, according to investigator assessment, is defined as the number (%) of subjects with at least one visit response of confirmed CR or PR
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End point type |
Primary
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End point timeframe |
tumor response was assessed by CT-scan every 8 week during treatment for the individual patients
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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: Single arm, not to be compared to historical data. Predictive probability based on the first 17 patients with possibility of 13 further observations was at only 0.7% (10 % was defined cut-off for continuation). Therefore, inclusion of patients was discontinued at the time. |
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| Notes [2] - At least one follow-up imaging (n=13) No post-baseline imaging (n=6) |
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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 |
AE were collected from initiation of study treatment until 100 days after discontinuation of dosing or until starting a new anti-neoplastic therapy (whichever occured first)
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Adverse event reporting additional description |
All serious AE are reported. Non serious adverse event are reported if events were assessed with causal relationship to study treatment only.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
NCI-CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
5
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Reporting groups
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Reporting group title |
Nivo/Ipi + SBRT and influenza vaccine
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Reporting group description |
SBRT of 15 Gy will be given on day 1 of the first cycle. Nivolumab 3 mg/kg (up to 240 mg maximum) will be given on day 1 (± 3 days) of each 14-day treatment cycle until the progression of disease or maximum of 48 weeks, discontinuation due to toxicity, withdrawal of consent. Ipilimumab 1 mg/kg will be given on day 1 cycle 1 (± 3 days) and once more after 6 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
| The study was prematurely ended as the predictive probability to meet efficacy gate (ORR 15%) was not given. | |||
