BCC - Basal Cell CarcinomaEarly Phase 1NCT04570683
Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell Carcinomas
A Early Phase 1 study testing Nivolumab 10 MG/ML and Ablative fractionated laser in people with BCC - Basal Cell Carcinoma and Immune Response, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BCC - Basal Cell Carcinoma, Immune Response, Immunotherapy
- What is being tested?
- Nivolumab 10 MG/ML and Ablative fractionated laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jan 2020to Nov 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Dermatology
Copenhagen, 2400
Silje Omland, MD, +4524402485, silje.haukali.omland.01@regionh.dk
About this study
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.
Read the detailed description
Explorative open label study. Patients and investigators are non-blinded and patients not randomized to interventions.
Three intervention groups:
- AFL monotherapy (8-10 patients)
- AFL+intratumoral nivolumab (8-10 patients)
- 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.
- Being tested
- Nivolumab 10 MG/ML, Ablative fractionated laser
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 10 MG/MLDrug
Also called opdivo
Se previously
Ablative fractionated laserDevice
Se previously
| Study group | Role | What they receive |
|---|---|---|
| AFL monotherapy | Active comparator | Singe dose AFL as monotherapy, 100 mJ Receives: 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 Receives: Drug: Nivolumab 10 MG/ML; Device: Ablative fractionated laser |
| nivolumab monotherapy | Active comparator | Intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor Receives: Drug: Nivolumab 10 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC
IHC as
- CD8/CD3 ratio
- CD4+Foxp3+/CD4 ratio
Measured: 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
Measured: 12 weeks
Secondary outcomes (3)
Tolerability of AFL, intratumoral nivolumab and AFL+Nivolumab
evaluated as local skin reactions 1 week and 12 weeks after exposure
Measured: 12 weeks
Detection of intra-tumoral Nivolumab
evaluated by ELISA with anti-anti-PD1
Measured: 1 week
Analysis and quantification of PD-L1 expression (tumor cells and TILs)
evaluated by IHC
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start27 Jan 2020
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCC - Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silje Haukali Omland, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570683
- Sponsor's protocol ID
- Eudra-CT: 2019-003310-14
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell
- ClinicalTrials.gov ID
- NCT04570683
- Acronym / sponsor ID
- Eudra-CT: 2019-003310-14
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Explorative open label study. Patients and investigators are non-blinded and patients not randomized to interventions.
Three intervention groups:
- AFL monotherapy (8-10 patients)
- AFL+intratumoral nivolumab (8-10 patients)
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AFL monotherapy | Active comparator | Device: Ablative fractionated laserSinge dose AFL as monotherapy, 100 mJ |
| AFL+nivolumab | Active comparator | Drug: Nivolumab 10 MG/ML, Device: Ablative fractionated laserSingle dose AFL 100 mJ followed by immediate intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor |
| nivolumab monotherapy | Active comparator | Drug: Nivolumab 10 MG/MLIntratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Concomitant treatment with 5-FU or imiquimod
- Concomitant chemotherapeutic treatment
- Concomitant systemic immunotherapeutic treatment, including Prednisolone
- Pregnant or lactating women
- Allergies to anti-PD1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab 10 MG/MLAlso: opdivoSe previously | Drug | AFL+nivolumab, nivolumab monotherapy |
| Ablative fractionated laserSe previously | Device | AFL monotherapy, AFL+nivolumab |
Primary outcome
immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC
Time frame: 1 week
IHC as * CD8/CD3 ratio * CD4+Foxp3+/CD4 ratio
investigate the clinical response of AFL and Nivolumab as monotherapy and AFL+Nivolumab in BCC
Time frame: 12 weeks
evaluated by tumor reduction measured in mm and documented by clinical photos
3 secondary outcomes
Tolerability of AFL, intratumoral nivolumab and AFL+Nivolumab
Time frame: 12 weeks
Detection of intra-tumoral Nivolumab
Time frame: 1 week
Analysis and quantification of PD-L1 expression (tumor cells and TILs)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nivolumab 10 MG/ML and Ablative fractionated laser in people with BCC - Basal Cell Carcinoma and Immune Response, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.