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

Part of paid clinical trials in Chevy Chase, Maryland.

Sponsor
Oncovir, Inc.
Study ID
NCT03721679
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Solid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Sep 25, 2018
Status verified
Dec 2020
Primary completion
Jan 26, 2021
Completion
Jan 26, 2021

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Poly-ICLC treatment combination aPD-1or aPD-1L1
    Weeks 1 and 2: Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM ONLY twice a week with a 48-72 hour interval between the two injections Weeks 3-25: 1. Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM twice a week with a 48-72 hour interval between the two injections, AND 2. ONLY 1 of the following regimens will be administered, per manufacturer's dosing and clinical oncologist's discretion as follows: * Nivolumab (Opdivo), OR * Pembrolizumab (Keytruda), OR * Cemiplimab (Libtayo) OR * Atezolizumab (Tecentriq) OR * Durvalumab (Imfinzi) Follow up: After completion of treatment subjects may be contacted by telephone at least twice over 12 months, or longer with patient consent, in order to inquire on their health status (e.g., in remission, progressive disease, on new cancer treatment).

Primary Outcome Measure

Tumor assessment [ Time Frame: 6 month timepoint compared to baseline ]

Locations (3)

FacilityCityStateZIPSite coordinators
Chevy Chase RCCAChevy ChaseMaryland20815-
Bay Hematology OncologyEastonMaryland21601-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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Chevy Chase RCCA· Chevy Chase, MDBay Hematology Oncology· Easton, MDIcahn School of Medicine at Mount Sinai· New York, NY

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