Abstract | Background: Patients and Methods: In this phase I/IIa, single center trial [NCT02275416], patients with metastatic melanoma received repeated UV1 vaccinations, with GM-CSF as an adjuvant, in combination with ipilimumab. Patients were evaluated for safety, efficacy and immune response. Immune responses against vaccine peptides were monitored in peripheral blood by measuring antigen-specific proliferation and IFN-γ production. Results: Twelve patients were recruited. Adverse events were mainly diarrhea, injection site reaction, pruritus, rash, nausea and fatigue. Ten patients showed a Th1 immune response to UV1 peptides, occurring early and after few vaccinations. Three patients obtained a partial response and one patient a complete response. Overall survival was 50% at 5 years. Conclusion: Treatment was well tolerated. The rapid expansion of UV1-specific Th1 cells in the majority of patients indicates synergy between UV1 vaccine and CTLA-4 blockade. This may have translated into clinical benefit, encouraging the combination of UV1 vaccination with standard of care treatment regimes containing ipilimumab/CTLA-4 blocking antibodies.
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Authors | Elin Aamdal, Else Marit Inderberg, Espen Basmo Ellingsen, Wenche Rasch, Paal Fredrik Brunsvig, Steinar Aamdal, Karen-Marie Heintz, Daniel Vodák, Sigve Nakken, Eivind Hovig, Marta Nyakas, Tormod Kyrre Guren, Gustav Gaudernack |
Journal | Frontiers in immunology
(Front Immunol)
Vol. 12
Pg. 663865
( 2021)
ISSN: 1664-3224 [Electronic] Switzerland |
PMID | 34046035
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 Aamdal, Inderberg, Ellingsen, Rasch, Brunsvig, Aamdal, Heintz, Vodák, Nakken, Hovig, Nyakas, Guren and Gaudernack. |
Chemical References |
- Biomarkers
- Cancer Vaccines
- Ipilimumab
- UV1 vaccine
- Telomerase
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Topics |
- Adult
- Aged
- Biomarkers
- Biopsy
- Cancer Vaccines
(administration & dosage, adverse effects, immunology)
- Combined Modality Therapy
- Female
- Follow-Up Studies
- Humans
- Ipilimumab
(administration & dosage, adverse effects, therapeutic use)
- Male
- Melanoma
(immunology, pathology, therapy)
- Middle Aged
- Telomerase
(antagonists & inhibitors, immunology)
- Treatment Outcome
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