E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cutaneous or subcutaneous malignant tumours |
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E.1.1.1 | Medical condition in easily understood language |
Cutaneous or subcutaneous malignant tumours |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10026693 |
E.1.2 | Term | Malignant skin neoplasm NOS |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. The evaluation will use the modified RECIST criteria, clinical examination with calliper measurement and photographical documentation using adhesive rulers for scale. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are to
• Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to evaluating treatment response after 2 months.
• Assess tumour and surrounding tissue response to treatment from biopsies of the treated area after 1 year.
• Assess response after treatment on MRI scans on a subset of patients before and immediately after treatment, as well as after 2 months.
• Evaluate patient quality of life before treatment, after 2 months and after 1 year through
o EORTC questionnaires.
o Qualitative interviews (in a subset of patients).
• Investigate any sign of systemic immunologic response from any routine scans before and after treatment in the inclusion period.
• To list response rates and response duration according to tumour histology.
• To determine complete and partial remissions for all tumours treated.
• To determine rate of response for each individual patient.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
CaEP-R-MRI:
Assess response after treatment on MRI scans on a subset of patients before and immediately after treatment, as well as after 2 months.
CaEP-R-QOL:
Evaluate patient quality of life before treatment, after 2 months and after 1 year through
o EORTC questionnaires.
o Qualitative interviews (in a subset of patients).
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E.3 | Principal inclusion criteria |
• Trial subject ≥ 18 years.
• Trial subject must be able to understand the participant information.
• Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
• The patient must have been offered other relevant standard treatment for their cancer disease.
• The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more.
• The patient can undergo radiation therapy, provided that the treatment field does not involve treated area.
• Performance status ECOG/WHO ≤2.
• At least one cutaneous or subcutaneous tumour measuring up to 3 cm.
• Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch).
• Signed informed consent.
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. The evaluation will use the modified RECIST criteria, clinical examination with calliper measurement and photographical documentation using adhesive rulers for scale. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluating treatment response after 2 months. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints are to
• Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to evaluating treatment response after 2 months.
• Assess tumour and surrounding tissue response to treatment from biopsies of the treated area after 1 year.
• Assess response after treatment on MRI scans on a subset of patients before and immediately after treatment, as well as after 2 months.
• Evaluate patient quality of life before treatment, after 2 months and after 1 year through
o EORTC questionnaires.
o Qualitative interviews (in a subset of patients).
• Investigate any sign of systemic immunologic response from any routine scans before and after treatment in the inclusion period.
• To list response rates and response duration according to tumour histology.
• To determine complete and partial remissions for all tumours treated.
• To determine rate of response for each individual patient.
• To investigate response (overall, as well as complete and partial) depending whether the treated tumour was in a previously irradiated area
• To measure current during treatment as measured by the pulse generator.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to evaluating treatment response after 2 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial is planned to end August 1, 2022. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |