We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03714529
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 8, 2020
University of Copenhagen
Information provided by (Responsible Party):
jeanette kaae, Herlev and Gentofte Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Biological: PD-L1 Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Trial With PD-L1 IO103 Vaccination With Montanide in Patients With Basal Cell Carcinoma
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Treatment arm

The 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.

Biological: PD-L1
IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide.
Other Name: IO103

Primary Outcome Measures :
  1. Clinical response [ Time Frame: All patients were evaluated 3 Month after last vaccination ]
    Evaluation and measurement of target BCC in cm2. Clinical response is evaluated as change in tumor size in mm.

  2. Disease control rate [ Time Frame: After 6 vaccinations with IO103 (10 weeks) ]
    Defined as change of the largest diameter of target BCC

  3. Immune responses [ Time Frame: After 6 vaccinations with IO103 (10 weeks) ]
    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)

Secondary Outcome Measures :
  1. Immune responses in skin [ Time Frame: After 6 vaccinations with IO103 (10 weeks) ]
    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

  2. Incidence of treatment emergent adverse events (safety and tolerability) [ Time Frame: From the time that the subject provides written informed consent and throughout the trial duration, until 30 days post last dose of trial treatment ]
    Events will be recorded and graded using CTCAE version 4.03

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18
  2. 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
  3. Willing to provide three 4 mm biopsies from the lesion/lesions
  4. Not previously treated with a hedgehog pathway inhibitor
  5. 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.
  6. For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm
  7. 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
  8. Sufficient bone marrow function, i.e.

    1. Leucocytes ≥ 1,5 x 109
    2. Granulocytes ≥ 1,0 x 109
    3. Thrombocytes ≥ 20 x 109

2. Creatinine < 2.5 upper normal limit, i.e. < 300 μmol/l 3. Sufficient liver function, i.e.

  1. ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/l
  2. Bilirubin < 30 U/l

Exclusion Criteria:

  1. 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
  2. The patient has a history of severe clinical autoimmune disease
  3. The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C
  4. The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
  5. The patient is pregnant or breastfeeding
  6. The patient has an active infection requiring systemic therapy
  7. The patient has received a live virus vaccine within 30 days of planned start of therapy
  8. Known side effects to Montanide ISA-51
  9. Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus
  10. Concurrent treatment with other experimental drugs
  11. 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.
  12. Severe allergy or anaphylactic reactions earlier in life.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714529

Layout table for location information
Herlev and Gentofte Hospital
Hellerup, Hovedstaden, Denmark, 2900
Sponsors and Collaborators
Herlev and Gentofte Hospital
University of Copenhagen
Layout table for investigator information
Study Director: Inge Marie Svane, Prof Herlev and Gentofte Hospital
Layout table for additonal information
Responsible Party: jeanette kaae, MD PhD, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT03714529    
Other Study ID Numbers: BCC1801
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell