Clinical Trial Results:
An Open-label, Multi-Center, Rollover Study in Patients with Advanced Melanoma After Completing an IMCgp100 Clinical Study
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Summary
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EudraCT number |
2016-002236-32 |
Trial protocol |
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Global end of trial date |
22 Apr 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
07 May 2020
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First version publication date |
07 May 2020
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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 |
IMCgp100-401
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02889861 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Immunocore
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Sponsor organisation address |
181 Washington Street, Conshohocken, United States,
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Public contact |
Shaad E. Abdullah, MD FACP, Immunocore, Ltd. , +1 267-422-4532, clinicaltrials@immunocore.com
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Scientific contact |
Shaad E. Abdullah, MD FACP, Immunocore, Ltd. , +1 267-422-4532, clinicaltrials@immunocore.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 |
22 Apr 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Apr 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Apr 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 |
The primary objective is to determine the number of participants with adverse events associated with IMCgp100 treatment.
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Protection of trial subjects |
Eligible participants were included in the study after providing written (witnessed, where required by law or regulation), IRB/IEC/REB-approved informed consent or, if incapable of doing so, after such consent had been provided by a legally acceptable representative of the participant. In cases where the participant’s representative gave consent, the participant was informed about the study to the extent possible given his/her understanding. If the participant was capable of doing so, he or she indicated assent by personally signing and dating the written informed consent document or a separate assent form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Nov 2016
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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 Kingdom: 3
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Worldwide total number of subjects |
3
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EEA total number of subjects |
3
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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) |
1
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
Eligible participants have tolerated IMCgp100 (77 kDa bi-specific protein) for a minimum of 4 weeks of dosing without significant toxicities that would preclude further dosing in the opinion of the principal investigator or Sponsor. | ||||||||||
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Pre-assignment
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Screening details |
Participants were eligible for enrollment in this study from parent studies that have completed and satisfied its primary endpoints or have been terminated by the Sponsor for reasons other than safety. | ||||||||||
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Period 1
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Period 1 title |
Regimen 1 (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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IMCgp100 weekly dosing regimen (QW) | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
IMCgp100
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Investigational medicinal product code |
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Other name |
Bispecific soluble HLA-A2 restricted gp100-specific TCR fused to anti-CD3
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
IMCgp100 dose as determined from previous regimen in parent IMCgp100 clinical study administered as an intravenous infusion over 15 minutes every week.
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Baseline characteristics reporting groups
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Reporting group title |
Regimen 1
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IMCgp100 weekly dosing regimen (QW)
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Reporting group description |
- | ||
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End point title |
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events [1] | ||||||||||||||||||||||
End point description |
Incidence of adverse events was presented as the number of participants with treatment-emergent adverse events (TEAEs). TEAEs were defined as adverse events (AEs) that started or worsened in severity from the date of first
dose of the rollover study (regardless of time) up until 90 days after the last dose of study drug of this rollover study. Participants with multiple events in the same category were counted only once in that category. Participants with events in more than 1 category were counted once in each of those categories. TEAEs indicated considered related to IMCgp100 were determined by the investigator to be possibly related or related to study drug.
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End point type |
Primary
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End point timeframe |
4 years
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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 statistical analysis was performed for this outcome as the outcome measure was a count of subjects by predefined category of TEAE. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Tolerability: Dose Interruptions and Reductions of IMCgp100 by Participant (Participant 4001001) | ||||||||||||||||||
End point description |
Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions and dose reductions. Reasons for dose interruptions and dose reductions were listed by participant and summarized.
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End point type |
Secondary
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End point timeframe |
4 years
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Tolerability: Dose Interruptions and Reductions of IMCgp100 by Participant (Participant 4002001) | ||||||||||||||||||
End point description |
Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions and dose reductions. Reasons for dose interruptions and dose reductions were listed by participant and summarized.
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End point type |
Secondary
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End point timeframe |
4 years
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Tolerability: Dose Interruptions and Reductions of IMCgp100 by Participant (Participant 4003001) | ||||||||||||||||||
End point description |
Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions and dose reductions. Reasons for dose interruptions and dose reductions were listed by participant and summarized.
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End point type |
Secondary
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End point timeframe |
4 years
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Assessments of Anti-IMCgp100 Antibody Formation: Number of Participants With Anti-IMCgp100 Antibody Formation | ||||||||
End point description |
The concentration/AE — immunogenicity relationship was explored graphically, and tabulated to characterize a relationship between the changes from screening immunogenicity presence and serum concentration of IMCgp100.
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End point type |
Secondary
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End point timeframe |
4 years
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| No statistical analyses for this end point | |||||||||
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End point title |
Overall Survival Status of All Participants Treated With IMCgp100: Number of Participants | ||||||||||||||
End point description |
This endpoint was used to estimate the overall survival (OS) in participants treated with IMCgp100. OS is defined as the time from the date of first dose of study drug in the parent study until death due to any cause. Any participant not known to have died at the time of analysis was right-censored based on the last recorded date on which the participant was known to be alive, i.e. the latest of (i) the “Date of death or Last contact” (for those participants still alive) on the End of Study electronic case report form page and (ii) “Date patient last known to be alive” on the Survival Follow Up eCRF page. Number of days was then converted to months.
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End point type |
Secondary
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End point timeframe |
4 years
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Dose Intensity of IMCgp100 by Participant (Participant 4001001) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
4 years
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Dose Intensity of IMCgp100 by Participant (Participant 4002001) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
4 years
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Dose Intensity of IMCgp100 by Participant (Participant 4003001) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
4 years
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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 |
All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
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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 |
22.0
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Reporting groups
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Reporting group title |
IMCgp100 weekly dosing regimen (QW)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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07 Nov 2016 |
Amendment 2 changes:
-Added criteria for treatment beyond progression (Protocol Section 6.6.1) and rationale (Protocol Section 2.4) and treatment discontinuation in the setting of treatment beyond progression
-Clarified that the dose and regimen of IMCgp100 was to be determined based upon the dose and schedule utilized in the parent study
-Extended the Follow-up Period from 30 days to 90 days
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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 | |||
