Trials / Completed
CompletedNCT03714529
A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma
Phase IIa Trial With PD-L1 IO103 Vaccination With Montanide in Patients With Basal Cell Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Herlev and Gentofte Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PD-L1 | IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide. |
Timeline
- Start date
- 2018-11-01
- Primary completion
- 2020-02-05
- Completion
- 2020-02-05
- First posted
- 2018-10-22
- Last updated
- 2020-10-08
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03714529. Inclusion in this directory is not an endorsement.