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

NCT04570683 | Unknown Early Phase 1 DMC

• 1 other identifier: Eudra-CT: 2019-003310-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC

  IHC as * CD8/CD3 ratio * CD4+Foxp3+/CD4 ratio

  1 week

• investigate the clinical response of AFL and Nivolumab as monotherapy and AFL+Nivolumab in BCC

  evaluated by tumor reduction measured in mm and documented by clinical photos

  12 weeks

Secondary Outcomes (3)

• Tolerability of AFL, intratumoral nivolumab and AFL+Nivolumab

  12 weeks

• Detection of intra-tumoral Nivolumab

  1 week

• Analysis and quantification of PD-L1 expression (tumor cells and TILs)

  2 weeks

Study Arms (3)

AFL monotherapy

ACTIVE COMPARATOR

Singe dose AFL as monotherapy, 100 mJ

Device: Ablative fractionated laser

AFL+nivolumab

ACTIVE COMPARATOR

Single dose AFL 100 mJ followed by immediate intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor

Drug: Nivolumab 10 MG/ML; Device: Ablative fractionated laser

nivolumab monotherapy

ACTIVE COMPARATOR

Intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor

Drug: Nivolumab 10 MG/ML

Interventions

Nivolumab 10 MG/ML DRUG

Se previously

Also known as: opdivo

AFL+nivolumab; nivolumab monotherapy

Ablative fractionated laser DEVICE

Se previously

AFL monotherapy; AFL+nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• 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

You may not qualify if:

• Concomitant treatment with 5-FU or imiquimod
• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Department of Dermatology

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 30, 2020
• Study Start: January 27, 2020
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

DK (1)