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Basal Cell CarcinomaPhase 2NCT03714529

A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma

A Phase 2 study testing PD-L1 in people with Basal Cell Carcinoma, run by Herlev and Gentofte Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A single center, open-label, phase IIa, single arm, window of opportunity trial with IO103 and Montanide adjuvant in patients with surgically resectable BCC. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
PD-L1
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteDenmark
Study dates
1 Nov 2018to 5 Feb 2020
Phase
Phase 2
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18
  • At least 1 histological verified superficial or nodular basal cell carcinoma on the body or limbs of bigger than 14 mm in the longest diameter
  • Willing to provide three 4 mm biopsies from the lesion/lesions
  • Not previously treated with a hedgehog pathway inhibitor
  • For women of childbearing potential: Agreement to use contraceptive methods with a failure rate of < 1 % per year during the treatment period and for at least 150 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant, contraceptive patch or contraceptive vaginal ring.
  • For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm
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  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Sufficient bone marrow function, i.e.
  • Leucocytes ≥ 1,5 x 109
  • Granulocytes ≥ 1,0 x 109
  • Thrombocytes ≥ 20 x 109
  • 2. Creatinine < 2.5 upper normal limit, i.e. < 300 μmol/l 3. Sufficient liver function, i.e.
  • ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/l
  • Bilirubin < 30 U/l

Who cannot join

  • The patient has a history of life-threatening or severe immune related adverse events on treatment with another immunotherapy and is considered to be at risk of not recovering
  • The patient has a history of severe clinical autoimmune disease
  • The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C
  • The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
  • The patient is pregnant or breastfeeding
  • The patient has an active infection requiring systemic therapy
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  • The patient has received a live virus vaccine within 30 days of planned start of therapy
  • Known side effects to Montanide ISA-51
  • Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus
  • Concurrent treatment with other experimental drugs
  • Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
  • Severe allergy or anaphylactic reactions earlier in life.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Herlev and Gentofte Hospital

    Hellerup, Capital Region, 2900

Other trials in Denmark

About this study

Official title: Phase IIa Trial With PD-L1 IO103 Vaccination With Montanide in Patients With Basal Cell Carcinoma

A single center, open-label, phase IIa, single arm, window of opportunity trial with IO103 and Montanide adjuvant in patients with surgically resectable BCC.

Read the detailed description

10 patients with BCC will be vaccinated with a peptide derived from the immune checkpoint molecule PD-L1. Patients will be vaccinated once every 2 weeks (Q2W) for 10 weeks and then evaluated for a clinical response.

Patients with clinical response to vaccination will continue with one vaccination once every 4 weeks (Q4W) for 12 weeks and thus receive 9 vaccinations in total over the course of 22 weeks.

Patients with no effect of treatment after 6 vaccinations will be treated with standard of care (SOC).

Being tested
PD-L1
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.

  • PD-L1Biological

    Also called IO103

    IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide.

Study groups in NCT03714529
Study groupRoleWhat they receive
Treatment armExperimentalThe vaccine consists of 500µl of 100µg PD-L1 peptide, dissolved in DMSO and PBS reconstituted with 500 µl Montanide ISA-51. Patients will be vaccinated Q2W for 10 weeks, and a further 12 weeks if a clinical response is measured.
Receives: Biological: PD-L1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response

    Evaluation and measurement of target BCC in cm2. Clinical response is evaluated as change in tumor size in mm.

    Measured: All patients were evaluated 3 Month after last vaccination

  2. Disease control rate

    Defined as change of the largest diameter of target BCC

    Measured: After 6 vaccinations with IO103 (10 weeks)

  3. Immune responses

    Immune responses in biopsies from basal cell carcinomas (BCC). Analyses which will include (but are not restricted to): Immunosign®CR/Pan Cancer Immune panel (gene expression level of multiple immune genes); Halioseek® CD8/PDL1(PDL1/CD8, CD8+ quantification by digital pathology, PDL1+ tumoral cells and Immune cells analysis by a pathologist); Immunoscore (CD3 and CD8 immune histochemistry (IHC) testing, scanning and image analysis); MHC Class I and II (IHC, scanning and image analysis)

    Measured: After 6 vaccinations with IO103 (10 weeks)

Secondary outcomes (2)

  1. Immune responses in skin

    Immune responses in skin delayed type hypersensitivity (DTH). Skin-infiltrating lymphocytes (SKILs) are tested for specificity to the PD-L peptides as a sign of induction of a functional immune response

    Measured: After 6 vaccinations with IO103 (10 weeks)

  2. Incidence of treatment emergent adverse events (safety and tolerability)

    Events will be recorded and graded using CTCAE version 4.03

    Measured: From the time that the subject provides written informed consent and throughout the trial duration, until 30 days post last dose of trial treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start1 Nov 2018
  3. Primary completion5 Feb 2020
  4. Study completion5 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03714529
Sponsor's protocol ID
BCC1801
Status last verified
Oct 2020
First submitted
27 Sep 2018
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Munir Ahmad S, Martinenaite E, Hansen M, Junker N, Borch TH, Met O, Donia M, Svane IM, Andersen MH. PD-L1 peptide co-stimulation increases immunogenicity of a dendritic cell-based cancer vaccine. Oncoimmunology. 2016 Jul 1;5(8):e1202391. doi: 10.1080/2162402X.2016.1202391. eCollection 2016 Aug.

    PubMed 27622072

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-L1 in people with Basal Cell Carcinoma, run by Herlev and Gentofte 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 14 inclusion and 12 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: finished, as of the sponsor's last update on 8 Oct 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response (time frame: All patients were evaluated 3 Month after last vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03714529, which also lists 1 linked publication.

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 8 Oct 2020.

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