The BLESS Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Sjaelland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Oct 2024 → ongoing

Decision date (initial)

2024-07-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Danish Cancer Society

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Dose response, Efficacy

The aim is to investigate if the standard dose of bleomycin in electrochemotherapy treatment can be reduced with 50 percent and retain the overall tumour response in patients with cutaneous malignancies

Conditions and MedDRA coding

Any cancer with cutaneous malignancies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. Trial subject > 18 years.
2. Trial subject must be able to understand the participant information.
3. Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
4. Life expectancy > 3 months.
5. Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study.
6. Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed.
7. Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed.
8. A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance > 50 ml/min.
9. Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization.
10. Signed informed consent.

Exclusion criteria 6

1. Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment.
2. Allergy or hypersensitivity to bleomycin.
3. Acute lung infection.
4. Severely impaired lung function or any lung condition the investigator deems severe.
5. Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit.
6. The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this study is to evaluate the clinical overall response rate of ECT treatment of cutaneous malignancies after three months.

Secondary endpoints 13

1. Treatment response for normal dose group, reduced dose group, and for all treated tumours at optional time points using RECIST criteria, digital photography and ruler.
2. Aesthetic outcome for normal dose group, reduced dose group and for all tumours after the time periods 2 to 6 months and 6 to 12 months, using the Vancouver Scar Scale and Patient and Observer Scar Assessment Scale (POSAS).
3. Complete and partial remissions for all patients treated (patient level), i.e. number of patients experiencing objective responses on at least one treated tumour.
4. Biopsy after 12 months (optional) for histological examination of malignancy presence (HE stain, and staining for specific tumour markers can be included).
5. All-cause mortality and cancer related mortality within 12 months.
6. Quality of life before treatment and at approximately 3 months. a. EORTC questionnaire C30 (all patients) – data from normal dose group, reduced dose group, and for the whole population will be registered and compared. b. Qualitative interviews (optional, subset of patients) – descriptive list of symptoms from normal dose group, reduced dose group, and for the whole population will be registered and compared.
7. Relation between tumour histology Response rates and response duration according to tumour histology – data from normal dose group, reduced dose group, and for the study population will be registered and compared.
8. Response rates and response duration in tumours according to size (≤3cm or > 3cm) – data from normal dose group, reduced dose group, and for the whole population will be registered and compared.
9. Side effects according to CTCAE according to treatment dose – data from normal dose group, reduced dose group, and for the whole population will be registered and compared.
10. The emergence of pain due to cutaneous malignancies, assessed using Numeric Rating Scale (NRS).
11. Pharmacokinetics (blood samples at 0, 5, 10, 20, 30 and 40 minutes after bleomycin infusion) will be analysed depending on age, treatment dose, Body Surface Area (BSA), kidney function (eGFR panel).
12. Bleomycin concentration in tumour (UHPLC-ESI-MS), including concentration vs time.
13. In order to examine if the faction of tumour cells in tumour biopsies matters for the bleomycin concentration at measured time points (0,2, 4, 6, 8 minutes after bleomycin infusion) the concentration of bleomycin in tumour tissue from the normal dose group, the reduced dose group, and for the whole population will be analysed and compared

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Sjaelland

Sponsor organisation

Region Sjaelland

Address

Sygehusvej 10

City

Roskilde

Postcode

4000

Country

Denmark

Scientific contact point

Organisation

Region Sjaelland

Contact name

Julie Gehl

Public contact point

Organisation

Region Sjaelland

Contact name

Julie Gehl

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications