NCT02423863|CompletedPhase 2DMC
In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol®
Poly-ICLC
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Sponsor study identifier
Secondary identifiers
interventional
26
1 country
5
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 31, 2020
Actual (reported)Study Completion
August 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 13, 2015
Actual (reported)April 22, 2015
Actual (reported)August 31, 2020
Actual (reported)August 31, 2020
Actual (reported)Evaluate safety of intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of patients with accessible solid tumors, with or with
Wk 26 study subject's response will be defined as BOR (CR, PR, SD) or PD.
Evaluation of response wk 26
Evaluate therapeutic efficacy assessed by Disease Control (CR, PR, or SD) as defined by the RECIST 1.1 Criteria.
Week 26 tumor assessment will be performed, an optional biopsy may be performed.
6 months
Determine whether the study regimen of Poly-ICLC will induce an innate and/or an adaptive, specific anti-tumor T cell immune response in the injected tumor lesion and systemically.
Open labeled, non randomized adaptive 2-stage design protocol. 21 study subjects were enrolled in stage I of the protocol. Up to an additional 60 patients. . 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. For purposes of analysis patients enrolled in Stage II of this study will be prospectively identified at initial screening as belonging to statistical Cohorts A, B, or C, which are based on patient status with regard to aPD1/aPDL1 therapy at study entry, (PD, SD, or treatment naïve). For purposes of this study, patient status is considered to be the primary eligibility variable, although sub analyses will also consider histology and particular checkpoint blocker used when possible.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chevy Chase RCCA
Chevy Chase, Maryland, 20815, United States
Dermatologic Surgery Center Washington DC
Chevy Chase, Maryland, 20815, United States
Bay Hematology Oncology
Easton, Maryland, 2160l, United States
University of Missouri School of Medicine
Columbia, Missouri, 65211-0001, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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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
26 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2015
First Posted
April 22, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
26 weeks
Determine the response in injected lesions as defined by change in size at 16 weeks and 26 weeks as assessed by bi-dimensional measurement using RECIST 1.1 criteria.
16 weeks and 26 weeks
Determine the response in non-injected tumor lesions, both visceral and non-visceral as defined by change in size at 16 weeks and 26 weeks as assessed by bi- dimensional measurement.
16 weeks and 26 weeks
Determine progression free survival at 12, 24, and 36 months in treated study subjects.
12, 24 and 36 months
Determine overall survival (OS) in treated study subjects.
Up to 36 months
Contact the study team to confirm eligibility.
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Zhu X, Nishimura F, Sasaki K, Fujita M, Dusak JE, Eguchi J, Fellows-Mayle W, Storkus WJ, Walker PR, Salazar AM, Okada H. Toll like receptor-3 ligand poly-ICLC promotes the efficacy of peripheral vaccinations with tumor antigen-derived peptide epitopes in murine CNS tumor models. J Transl Med. 2007 Feb 12;5:10. doi: 10.1186/1479-5876-5-10.
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Primary Completion
August 31, 2020
Actual (reported)Study Completion
August 31, 2020
Actual (reported)Last Updated
December 17, 2020
Record last verified: 2017-09
No plan to share data
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