In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol®

Summary

The purpose of this study is to evaluate the safety of sequential intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of study subjects with accessible solid tumors, with or without checkpoint blockers. Enrolled study subjects will receive Poly-ICLC (Hiltonol®) treatment alone or in combination with anti-PD-1 (Nivolumab, Pembrolizumab or Cemiplimab) or anti-PD-L1 (Atezolizumab or Durvalumab) over 6 months as defined in study treatment described below. MRI or CT imaging will be done per SOC at screening, 3 and 6-month time points.

Conditions

• Melanoma
• Head and Neck Cancer
• Sarcoma
• Non-Melanoma Skin Cancers

Interventions

BIOLOGICAL

Hiltonol

Wk 1 Days 1, 3 and 5: Poly-ICLC (Hiltonol®) 1 mg (0. 5 ml) IntraTumoral (priming treatment course). Weeks 2-25 Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM twice a week with a 48-72 hour interval between the two injections, AND either: No additional immunotherapy OR ONLY ONE of the Anti-PD1 or anti-PDL-1 regimens will be administered, per manufacturer's dosing and clinical oncologist's discretion as follows: (Not to be Administered on the same day as Poly-ICLC \[Hiltonol®\]) Either Nivolumab, OR Pembrolizumab, OR Atezolizumab, OR Cemiplimab, OR Durvalumab

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Bay Hematology Oncology

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• University of Missouri-Columbia

  collaborator OTHER

• Chevy Chase Regional Cancer Care Associates LLC

  collaborator UNKNOWN

• Dermatologic Surgery Center of Washington LLC and Skin Cancer Treatment Center

  collaborator UNKNOWN

• Oncovir, Inc.

  lead INDUSTRY

Principal Investigators

• Nina Bhardwaj, MD, PhD · Icahn School of Medicine at Mount Sinai

• David H Smith, MD · Bay Hematology Oncology

• Kevin Staveley-O'Carroll, MD · University Missouri

• Frederick P Smith, MD · Chevy Chase, RCCA

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2020-08-31

Completion

2020-08-31

Countries

• United States

Study Locations