Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell Carcinomas

Sponsor
Bispebjerg Hospital
Study ID
NCT04570683
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Ablative Fractionated Laser
  • BCC - Basal Cell Carcinoma
  • Immune Response
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 10 MG/ML — DRUG
    Se previously
  • Ablative fractionated laser — DEVICE
    Se previously

Study Details

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.

Key Dates

Start date
Jan 27, 2020
Status verified
Sep 2020
Primary completion
Sep 30, 2021
Completion
Nov 30, 2021

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AFL monotherapy
    Singe dose AFL as monotherapy, 100 mJ
  • Active Comparator: AFL+nivolumab
    Single dose AFL 100 mJ followed by immediate intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor
  • Active Comparator: nivolumab monotherapy
    Intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor

Primary Outcome Measure

immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC [ Time Frame: 1 week ]

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