Clinical trial · Interventional
Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell Carcinomas
Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell
NCT04570683CI-TRIAL-00047420unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ablative Fractionated Laser | — | UNRESOLVED | — |
| BCC - Basal Cell Carcinoma | Basal Cell Carcinoma | PROBABILISTIC | 0.70 |
| Immune Response | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablative fractionated laser | Device | — | UNRESOLVED |
| Nivolumab 10 MG/ML | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- AFL monotherapy
- description
- Singe dose AFL as monotherapy, 100 mJ
- interventionNames
- Device: Ablative fractionated laser
- type
- ACTIVE_COMPARATOR
- label
- AFL+nivolumab
- description
- Single dose AFL 100 mJ followed by immediate intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor
- interventionNames
- Drug: Nivolumab 10 MG/ML
- Device: Ablative fractionated laser
- type
- ACTIVE_COMPARATOR
- label
- nivolumab monotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.