Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1

Solid Cancer Clinical Trial

Official title: Poly-ICLC (Hiltonol®) Plus Anti-PD1 or Anti-PD-L1 in Unresectable Solid Cancers An Adaptive Phase I/II Clinical Pilot Study

Status Terminated

Clinical Trial 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)

Clinical Trial Description

This research study is a PhaseI/II clinical trial investing a combination of targeted therapies as possible treatment for advanced solid cancers

FDA has not yet approved Poly-ICLC as treatment for diseases in this study

Pembrolizumab, Nivolumab, Atezolizumab, Cemiplimab and Durvalumab are now FDA approved for certain patients with multiple cancer types.

The study is designed to evaluate the safety of intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®) in combination with Anti-PD-1 or Anti-PD-L1 for treatment of study subjects with advanced solid cancers. ;

Related Conditions & MeSH terms

• Solid Cancer

• NCT number: NCT03721679
• Study type: Interventional
• Source: Oncovir, Inc.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 25, 2018
• Completion date: January 26, 2021