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

Phase 1

Terminated

• Conditions: Solid Cancer

• Registration Number: NCT03721679
• Lead Sponsor: Oncovir, Inc.

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.

Study Timeline

• Study Start: 2018-09-25
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Status Verified: 2020-12
• Primary Completion: 2021-01-26
• Study Completion: 2021-01-26
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Tumor assessment	6 month timepoint compared to baseline	Response and progression will be evaluated in this study. Tumor Response will be assessed by the RECIST 1.1 Criteria. Response is defined as CR, PR or SD over a period of at least 4 weeks. Changes in the sum of the two largest perpendicular diameters (SPD) of the tumor lesions, or the shortest diameter in the case of malignant lymph nodes are used in the RECIST 1.1 criteria. Study subjects with progressive disease will be evaluated to determine whether the progression causes symptoms and/or functional decline and study subjects with non-clinically relevant progression of disease may remain on study at the investigator's discretion.

Trial Locations

Locations (3)

Chevy Chase RCCA; 🇺🇸 Chevy Chase, Maryland, United States

Bay Hematology Oncology; 🇺🇸 Easton, Maryland, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States