Clinical Trial Results:
A Novel Phase I/IIa Open label Study of IMM 101 in Combination with Selected Standard of Care (SOC) Regimens in Patients with Metastatic Cancer or Unresectable Cancer at Study Entry.
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Summary
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EudraCT number |
2016-001459-28 |
Trial protocol |
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Global end of trial date |
30 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Mar 2019
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First version publication date |
21 Mar 2019
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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 |
IMM-101-011
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03009058 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Immodulon Therapeutics Ltd
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Sponsor organisation address |
6-9 The Square, Stockley Park, Uxbridge, United Kingdom, UB11 1FW
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Public contact |
Clinical Trial Information Desk, Immodulon Therapeutics Ltd, info@immodulon.com
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Scientific contact |
Clinical Trial Information Desk, Immodulon Therapeutics Ltd, info@immodulon.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 |
26 Oct 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Aug 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Aug 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 |
The primary objective of the study was to provide safety data for IMM-101 in combination with a number of selected chemotherapy regimens in patients with unresectable or metastatic cancer.
Secondary objectives included safety data for the combination of IMM-101 with anti-programmed death-1 (anti-PD-1) (pembrolizumab, nivolumab) regimens and with anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) (ipilimumab) regimens and preliminary data regarding the activity of IMM-101 (in terms of response to treatment) in combination with selected SOC regimens in a number of different tumour types.
Only two patients were enrolled into the study before the study was terminated early by the Sponsor, after a review of the resources required to complete the study concluded that sufficient funding for completion of the study could not be guaranteed. Hence, no formal analysis could be conducted and the objectives of the study could not be met.
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Protection of trial subjects |
This clinical study was conducted in compliance with the study protocol, and in accordance with the provisions of the guidelines of the WMA Declaration of Helsinki, as amended by the 64th World Medical Association (WMA) General Assembly, Fortaleza, Brazil, October 2013, the guidelines of ICH-GCP (CPMP/ICH/135/95), designated standard operating procedures (SOPs), and with local laws and regulations relevant to the use of new therapeutic agents.
An internal safety review committee reviewed the clinical safety data twice during the course of the study.
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Background therapy |
Specified tumour types and standard care regimes were allowed per protocol. Patients could only be considered for entry into the study when they were commencing a new line of standard care. Patients were to be enrolled into different cohorts depending on their tumour type and standard of care. Only 2 patients were enrolled; both into the cohort receiving anti-PD-1 (nivolumab) alongside IMM-101. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 May 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 Kingdom: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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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 |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Two patients were enrolled before the study was terminated early by the Sponsor. Both patients were enrolled into the cohort for patients with advanced melanoma receiving standard of care anti-PD-1 (nivolumab). | ||||||||||
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Pre-assignment
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Screening details |
Patients aged ≥18 years were eligible for the study if they had metastatic or unresectable cancer and were considered by their physician to be indicated for a new line of standard care therapy as specified in the protocol. Three patients were screened and two were eligible and enrolled into the study. | ||||||||||
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Period 1
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Period 1 title |
Study 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 | ||||||||||
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Arms
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Arm title
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Metastatic melanoma and IMM-101 + nivolumab | ||||||||||
Arm description |
Patients with metastatic melanoma receiving nivolumab + IMM-101 | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Heat killed Mycobacterium obuense NCTC13365 (IMM-101)
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Investigational medicinal product code |
UPI EMA/569517 (IMM-101)
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Other name |
IMM-101
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
IMM-101 (10 mg/mL) administered as a single 0.1 mL intradermal injection into the skin overlying the deltoid muscle, with the arm being alternated between each dose. The first three patients receiving anti-PD-1 (nivolumab) received one dose of IMM-101 every 4 weeks throughout. In the absence of safety signals, subsequent patients treated with anti-PD-1 would be dosed with the standard IMM-101 dosing regimen which comprised: one dose given every 2 weeks for the first three doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next three doses followed by a dose every 4 weeks thereafter. Dosing was to be continued to a maximum of 28 weeks in the Treatment Phase. A Maintenance Phase of ongoing treatment with IMM-101 approximately every 4 weeks (starting from Week 28) for up to 4.5 years was also planned.In practice, only 2 patients were enrolled, both into the cohort receiving anti-PD-1 (nivolumab).
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Baseline characteristics reporting groups
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Reporting group title |
Study period
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Reporting group description |
All enrolled patients. Both enrolled patients received study drug (IMM-101) and nivolumab | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Metastatic melanoma and IMM-101 + nivolumab
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Reporting group description |
Patients with metastatic melanoma receiving nivolumab + IMM-101 | ||
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End point title |
Safety assessment [1] | ||||||
End point description |
It was planned to assess AEs, related AEs and SAEs according to the proportion of patients having at least one event, by coded terms, and by severity. Adverse events leading to withdrawal or death would have been assessed. As the study terminated early with only 2 patients enrolled, no statistical assessment of safety could be made.
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End point type |
Primary
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End point timeframe |
Adverse events were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal
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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 study terminated early when only 2 patients had been enrolled so the planned statistical analyses and data presentations described in the study protocol were therefore not carried out. The data collected were listed only and not tabulated or analysed further. |
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| No statistical analyses for this end point | |||||||
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End point title |
Tumour response | ||||||
End point description |
The activity of IMM-101 was planned to be assessed for each standard of care by tumour type by assessing the response rate after the tenth patient in each standard of care/tumour type cohort reached the Week 28 visit.
A CT/MRI scan was performed at baseline (either a scan performed in the 30 days prior to screening or a scan performed at screening) and the first post-baseline scan was planned at Week 12. Due to the early termination of the study, both enrolled patients had their only post-baseline scan at their end of study visit which was approximately 11 weeks following first dose of IMM-101. The response to treatment according to immune-related Response Criteria (irRC) was assessed. A response was defined according to irRC as either immune-related partial response or immune-related complete response.
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End point type |
Secondary
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End point timeframe |
A CT/MRI scan was performed at baseline (either a scan performed in the 30 days prior to screening or a scan performed at screening) and the post-baseline scan was at approximately 11 weeks following first dose of IMM-101.
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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 |
Adverse events were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal.
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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 |
20
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Reporting groups
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Reporting group title |
Safety population
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Reporting group description |
All patients in the safety population, i.e. all patients receiving at least one dose of IMM-101, the investigational medicinal product. | ||||||||||||||||||||||||||||||||||||||
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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. | |||
| Due to the early termination of this study, the objectives of the study could not be met and no meaningful assessment of safety and efficacy could be made. | |||
