Immunotherapy Clinical Trial
Official title:
Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell
The study aim is to assess the immunological and clinical response in basal cell carcinoma (BCC) treated with ablative fractionated laser (AFL) as monotherapy and compare with BCC treated with combination-therapy of AFL and the anti-PD1-drug nivolumab and with nivolumab as monotherapy.
Explorative open label study. Patients and investigators are non-blinded and patients not
randomized to interventions.
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.
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