Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04570683
Study type Interventional
Source Bispebjerg Hospital
Contact
Status Recruiting
Phase Early Phase 1
Start date January 27, 2020
Completion date November 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05848011 - A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Recruiting NCT06165900 - Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC Phase 2
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT06262581 - Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery Phase 2
Recruiting NCT05176002 - Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma. Phase 1/Phase 2
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Recruiting NCT04500990 - MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
Not yet recruiting NCT04372732 - Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Completed NCT03763630 - MAPS & ITEC Cohorts: 6-8 Years Follow-up Phase 2
Not yet recruiting NCT06012318 - Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Not yet recruiting NCT05479240 - Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer Phase 2
Recruiting NCT04711330 - Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
Recruiting NCT05515796 - Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors Phase 2
Recruiting NCT03701607 - Effect of Chemotherapy on PD-L1 in NSCLC
Recruiting NCT03683407 - Effect of Chemotherapy on TMB in NSCLC
Completed NCT03357861 - Cancer Patients Treated With Immunotherapy in Intensive Care Unit
Recruiting NCT05223088 - Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer Phase 2
Completed NCT05657262 - Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas N/A