A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma

NCT03714529 | Completed Phase 2 DMC

• 1 other identifier: BCC1801
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Clinical response

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

  All patients were evaluated 3 Month after last vaccination

• Disease control rate

  Defined as change of the largest diameter of target BCC

  After 6 vaccinations with IO103 (10 weeks)

• 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)

  After 6 vaccinations with IO103 (10 weeks)

Secondary Outcomes (2)

• Immune responses in skin

  After 6 vaccinations with IO103 (10 weeks)

• Incidence of treatment emergent adverse events (safety and tolerability)

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

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Interventions

PD-L1 BIOLOGICAL

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

Also known as: IO103

Treatment arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• \. 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Herlev and Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27622072 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Inge Marie Svane, Prof

  Herlev and Gentofte Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 22, 2018
• Study Start: November 1, 2018
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)