A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03714529|
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Biological: PD-L1||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide.
Other Name: IO103
- 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.
- Disease control rate [ Time Frame: After 6 vaccinations with IO103 (10 weeks) ]Defined as change of the largest diameter of target BCC
- 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)
- 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
- 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
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
|Herlev and Gentofte Hospital|
|Hellerup, Hovedstaden, Denmark, 2900|
|Study Director:||Inge Marie Svane, Prof||Herlev and Gentofte Hospital|