NCT03721679

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Oncovir, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Solid Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months	Same as above

Timeline

• Start date: 2018-09-25
• Primary completion: 2021-01-26
• Completion: 2021-01-26
• First posted: 2018-10-26
• Last updated: 2021-02-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study