Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell Carcinomas
NCT ID: NCT04570683
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
30 participants
INTERVENTIONAL
2020-01-27
2021-11-30
Brief Summary
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Detailed Description
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Three intervention groups:
1. AFL monotherapy (8-10 patients)
2. AFL+intratumoral nivolumab (8-10 patients)
3. Intratumoral nivolumab monotherapy (8-10 patients)
Patients will attend 4 visits Immunological response is determined by immunohistochemistry (IHC) analysis from biopsies taken prior to AFL, AFL+Nivolumab or Nivolumab treatment (baseline) and compared with biopsies 1 week after treatment. Further, comparison of the immunological response of AFL monotherapy with immunological response AFL+Nivolumab and Nivolumab as monotherapy will be performed.
Patients included for AFL as monotherapy will after tumor demarcation receive AFL of the BCC including a 5 mm margin. An occlusive bandage will be applied to the treated area and is to be removed by the patient 24 hours after treatment or after end of secretion/oozing from the treated area.
Patients included for AFL+Nivolumab will after tumor demarcation receive AFL of the BCC including a 5 mm margin, immediately followed by intratumoral injection of Nivolumab. An occlusive bandage will be applied to the treated area and is to be removed by the patient 24 hours after treatment or after end of secretion/oozing form the treated area.
Patients included for monotherapy with Nivolumab will after tumor demarcation get an intratumoral injection of Nivolumab. An occlusive bandage will be applied to the treated area and is to be removed by the patient 24 hours after treatment or after end of secretion from the treated area.
All patients will have a final visit at week 15, around 12 weeks after first treatment, where the clinical response will be evaluated, and treated tumor will be treated following national guidelines for treatment of BCCs.
For subgroups of clinical responders and non-responders tumor will at week 15 be used for multiplex gene expression analysis via nanostring (Pan cancer immune profiling panel).
For all groups, clinical photographs are taken at every study visit. For patients that present with more than one tumor, patients will be invited to participate with all tumors relevant to the study.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AFL monotherapy
Singe dose AFL as monotherapy, 100 mJ
Ablative fractionated laser
Se previously
AFL+nivolumab
Single dose AFL 100 mJ followed by immediate intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor
Nivolumab 10 MG/ML
Se previously
Ablative fractionated laser
Se previously
nivolumab monotherapy
Intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor
Nivolumab 10 MG/ML
Se previously
Interventions
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Nivolumab 10 MG/ML
Se previously
Ablative fractionated laser
Se previously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical suspicion of BCC or histologically verified BCC at baseline and histologically verified BCC at visit 2, irrespective of histologic subtype with diameter ≥7 mm at baseline.
* Signed informed consent.
* Female subjects of childbearing potential\* must be confirmed not pregnant by a negative pregnancy test prior to study treatment and must use a safe contraceptive method
Exclusion Criteria
* Concomitant chemotherapeutic treatment
* Concomitant systemic immunotherapeutic treatment, including Prednisolone
* Pregnant or lactating women
* Allergies to anti-PD1
* Patients with a tendency to form keloids
* Other skin diseases or tattoos in the treatment area
18 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Responsible Party
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Silje Haukali Omland
Principal Investigator
Locations
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Department of Dermatology
Copenhagen, , Denmark
Countries
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Facility Contacts
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Silje Omland, MD
Role: primary
Other Identifiers
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Eudra-CT: 2019-003310-14
Identifier Type: -
Identifier Source: org_study_id