Spots Global Cancer Trial Database for Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1

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Trial Identification

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

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

Study ID: NCT03721679

Conditions

Solid Cancer

Interventions

Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months

Study Description

Brief 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.