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

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
MelanomaHead and Neck CancerSarcomaNon-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"

Trial Locations (5)

10029

Icahn School of Medicine at Mount Sinai, New York

20815

Chevy Chase RCCA, Chevy Chase

Dermatologic Surgery Center Washington DC, Chevy Chase

2160l

Bay Hematology Oncology, Easton

65211-0001

University of Missouri School of Medicine, Columbia

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Icahn School of Medicine at Mount Sinai

OTHER

collaborator

Bay Hematology Oncology

UNKNOWN

collaborator

National Cancer Institute (NCI)

NIH

collaborator

University of Missouri-Columbia

OTHER

collaborator

Chevy Chase Regional Cancer Care Associates LLC

UNKNOWN

collaborator

Dermatologic Surgery Center of Washington LLC and Skin Cancer Treatment Center

UNKNOWN

lead

Oncovir, Inc.

INDUSTRY