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800 A phase I dose escalation and expansion study of intratumorally administered CV8102 as a single-agent or in combination with anti-PD-1 antibodies in patients with advanced solid tumors
  1. Thomas Eigentler1,
  2. Lucie Heinzerling2,
  3. Jürgen Krauss3,
  4. Carsten Weishaupt4,
  5. Peter Mohr5,
  6. Sebastian Ochsenreither6,
  7. Patrick Terheyden7,
  8. Juan Martin-Liberal8,
  9. Marc Oliva8,
  10. Céleste Lebbe9,
  11. Michael Fluck10,
  12. Peter Brossart11,
  13. Jose Manuel Trigo Perez12,
  14. Franz-Georg Bauernfeind11,
  15. Sarah-Katharina Kays13,
  16. Tobias Seibel13,
  17. Oliver Schönborn-Kellenberger13,
  18. Claudia Stosnach13,
  19. Angelika Daehling13,
  20. Beate Schmitt-Bormann13 and
  21. Ulrike Gnad-Vogt13
  1. 1University Medical Center Tübingen, Tübingen, Germany
  2. 2University of Erlangen, Erlangen, Germany
  3. 3National Center for Tumor Diseases (NCT), Heidelberg, Germany
  4. 4University of Münster, Münster, Germany
  5. 5Elbe Medical Center, Buxtehude, Germany
  6. 6Charité Campus Benjamin Franklin, Berlin, Germany
  7. 7University of Lübeck, Lübeck, Germany
  8. 8Hospital Duran i Reynals, Barcelona, Spain
  9. 9Hôpital Saint Louis, Paris, France
  10. 10Fachklinik Hornheide, Münster, Germany
  11. 11University Clinic Bonn, Bonn, Germany
  12. 12Hospital Clínico V de la Victoria, Málaga, Spain
  13. 13CureVac AG


Background CV8102 is a non-coding, non-capped RNA complexed with a carrier peptide activating the innate (via TLR7/8, RIG-I) and adaptive immune system.1 2 An ongoing phase I trial is investigating i.t. CV8102 either as a single agent or in combination with systemic anti-PD-1 antibodies in patients with advanced melanoma (MEL), squamous cell carcinoma of the skin (cSCC) or head and neck (hnSCC) and adenoid cystic carcinoma (ACC).

Methods An open-label, cohort-based, dose escalation and expansion study in patients with advanced cutaneous melanoma (cMEL), cutaneous squamous cell carcinoma (cSCC), head and neck squamous cell carcinoma (hnSCC) or adenoid cystic carcinoma (ACC) is ongoing investigating i.t. CV8102 as single agent and in combination with anti-PD-1 antibodies.

8 intratumoral injections of CV8102 are being administered initially over a 12 week period, while patients benefiting from the single agent therapy may receive further treatment. In an initial dose escalation part the maximum tolerated dose and recommended phase 2 dose for subsequent cohort expansion will be defined.

Results As of September 16, 2020, 29 patients have been treated with CV8102 as a single agent (25-900 µg) and 21 patients have received CV8102 (25-900 µg) in combination with anti-PD-1 antibodies. Most frequent treatment related adverse events were mild to moderate fever, fatigue, chills and headache. One patient treated at the 900 µg single agent experienced a dose limiting toxicity (G3 transaminase increase in the context of G2 cytokine release syndrome).

Regression of injected and distant noninjected lesions was observed in several patients in the single agent and the anti-PD-1 combination cohorts. Updated safety and efficacy results will be presented.

Conclusions CV8102 showed an acceptable tolerability and preliminary evidence of clinical efficacy as single agent and in combination with anti-PD-1- antibodies.

Trial Registration NCT03291002

Ethics Approval The study was approved by the Central Ethics Committees in Tuebingen, Germany under 785/2016AMG1, in France under, in Barcelona, Spain under the EudraCT number.

Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.


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