drugset / Trial / NCT03721679
Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1
Phase 1/2
Terminated
7 enrolled
Oncovir, Inc.
Bay Hematology Oncology PA, Easton MD · collabChevy Chase Healthcare, Chevy Chase MD · collabMt. Sinai School of Medicine, New York, New York · collab
NaSequentialOpen-labelTreatment
Summary
This is an open labeled, non-randomized adaptive pilot study. The study interventions involved in this study are: Poly-ICLC (Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose, also known as Hiltonol®) treatment in combination with anti-PD-1 (Nivolumab, Cemiplimab or Pembrolizumab) or anti-PD-L1 (Atezolizumab or Durvalumab)
Timeline
- Start
- 2018-09-25
- Primary completion
- 2021-01-26
- Completion
- 2021-01-26
Outcome
Outcome not reported
Stopped (Enrollment): “Recruiting target patients is intermittent making it impracticable to enroll the required study sample. The administrative responsibilities have been met with extraordinary challenges. Current funding does not match the incurring costs.”
Publications
- Results Bosio CM, Aman MJ, Grogan C, Hogan R, Ruthel G, Negley D, Mohamadzadeh M, Bavari S, Schmaljohn A. Ebola and Marburg viruses replicate in monocyte-derived dendritic cells without inducing the production of cytokines and full maturation. J Infect Dis. 2003 Dec 1;188(11):1630-8. doi: 10.1086/379199. Epub 2003 Nov 14.
- Results Brody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, Kim YH, Hoppe RT, Knox SJ, Shin LK, Wapnir I, Tibshirani RJ, Levy R. In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: a phase I/II study. J Clin Oncol. 2010 Oct 1;28(28):4324-32. doi: 10.1200/JCO.2010.28.9793. Epub 2010 Aug 9.
- Results Caskey M, Lefebvre F, Filali-Mouhim A, Cameron MJ, Goulet JP, Haddad EK, Breton G, Trumpfheller C, Pollak S, Shimeliovich I, Duque-Alarcon A, Pan L, Nelkenbaum A, Salazar AM, Schlesinger SJ, Steinman RM, Sekaly RP. Synthetic double-stranded RNA induces innate immune responses similar to a live viral vaccine in humans. J Exp Med. 2011 Nov 21;208(12):2357-66. doi: 10.1084/jem.20111171. Epub 2011 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | — |
| Subject | Cemiplimab | Monoclonal antibody | — | — |
| Subject | Durvalumab | Monoclonal antibody | — | — |
| Subject | Hiltonol | Other / unclassified | 1 mg | Intramuscular |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
Indications
No indication recorded.