Clinical Trial Results:
A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factor
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Summary
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EudraCT number |
2016-004743-37 |
Trial protocol |
BE GB SE HU DK |
Global end of trial date |
10 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Apr 2021
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First version publication date |
14 Apr 2021
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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 |
GCT1015-03
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03245736 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Genmab A/S
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Sponsor organisation address |
Kalvebod Brygge 43, Copenhagen V, Denmark, DK-1560
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Public contact |
Clinical Trial Information, Genmab A/S, +45 70202728, clinicaltrials@genmab.com
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Scientific contact |
Clinical Trial Information, Genmab A/S, +45 70202728, clinicaltrials@genmab.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 |
10 Jan 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jan 2019
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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 |
To collect long-term safety data from participants with solid tumors who have been treated with tisotumab vedotin and completed any base trial (i.e., GEN701 - 2013-001074-15 or GEN702 - 2015-001120-29)
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Protection of trial subjects |
This trial was conducted in accordance with the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6 (R2); the United States of America (USA) Food and Drug Administration (FDA) Code of Federal Regulations (CFR) (21 CFR § 50, 56, 312), the Declaration of Helsinki (Fortaleza 2013), and all applicable regulatory requirements.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
23 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 |
United States: 1
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Country: Number of subjects enrolled |
United Kingdom: 4
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Worldwide total number of subjects |
5
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EEA total number of subjects |
4
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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) |
5
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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 participants entered the trial following completion of other tisotumab vedotin trials such as GEN701 and GEN702. A total of 5 participants took part in the trial at 3 sites in the United Kingdom and 1 site in the United States from 23 August 2017 to 10 January 2019. | ||||||||||||
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Pre-assignment
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Screening details |
Six participants were screened, 5 of which were enrolled. | ||||||||||||
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Period 1
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Period 1 title |
Overall Study (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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Tisotumab Vedotin | ||||||||||||
Arm description |
Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Tisotumab vedotin
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Investigational medicinal product code |
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Other name |
HuMax®-TF-ADC
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Pharmaceutical forms |
Powder for concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Participants received 2.0 mg/kg or if dose reduced, the same dose as in base trial by intravenous infusion, over a minimum of 30 minutes.
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Baseline characteristics reporting groups
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Reporting group title |
Tisotumab Vedotin
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Reporting group description |
Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tisotumab Vedotin
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Reporting group description |
Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial. | ||
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End point title |
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE) [1] | ||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.
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End point type |
Primary
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End point timeframe |
Day 1 to Week 24 plus 30 days
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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: Given the low expected number of participants, no formal statistical analyses were planned. |
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| No statistical analyses for this end point | |||||||
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End point title |
Objective Response Rate | ||||||||||||||
End point description |
Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] criteria. The best overall response was reported for each participant.
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End point type |
Secondary
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End point timeframe |
Day 1 to Week 24 plus 30 days
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Participants with Increased Cancer Antigen (CA 125) Levels | ||||||
End point description |
The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.
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End point type |
Secondary
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End point timeframe |
Day 1 to Week 24 plus 30 days
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Participants with Increased Prostate Specific Antigen (PSA) | ||||||
End point description |
The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.
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End point type |
Secondary
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End point timeframe |
Day 1 to Week 24 plus 30 days
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| Notes [2] - No participants with prostate cancer participated in this trial. |
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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 |
Day 1 to Week 24 plus 30 days
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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 |
21.0
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Reporting groups
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Reporting group title |
Overall
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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? Yes | |||
Date |
Amendment |
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22 Dec 2016 |
The purpose of this protocol amendment was to modify the dose modification and the mitigation plan for ocular events accordingly. |
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27 Jul 2017 |
The purpose for this amendment was to align the treatment schedule with one of the base trials, and implement improved mitigation plan for ocular AE and reporting requirement. |
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30 Nov 2017 |
The protocol was amended to align with one of the base trials updated inclusion and exclusion criteria, permitted concomitant medications and AEs including medication errors, overdose and pregnancies reporting requirement. |
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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 | |||
