In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol® (Poly-ICLC)
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|ClinicalTrials.gov Identifier: NCT02423863|
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Head and Neck Cancer Sarcoma Non-Melanoma Skin Cancers||Biological: Hiltonol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol® (Poly-ICLC): An Adaptive, Multicenter, Phase II Clinical Study|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||August 31, 2020|
|Actual Study Completion Date :||August 31, 2020|
Experimental: Hiltonol Poly-ICLC
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
- 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 [ Time Frame: Evaluation of response wk 26 ]Wk 26 study subject's response will be defined as BOR (CR, PR, SD) or PD.
- Evaluate therapeutic efficacy assessed by Disease Control (CR, PR, or SD) as defined by the RECIST 1.1 Criteria. [ Time Frame: 6 months ]Week 26 tumor assessment will be performed, an optional biopsy may be performed.
- 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. [ Time Frame: 26 weeks ]Serial blood samples collected at certain time points and processed and used to evaluate humoral and cellular immunity induced by IT and IM polyICLC injections
- 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. [ Time Frame: 16 weeks and 26 weeks ]In the present protocol, we propose to induce both innate and adaptive cellular immune mechanisms with IT injections of poly-ICLC (Nierkens, den Brock et al. 2008)
- 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. [ Time Frame: 16 weeks and 26 weeks ]Bi-dimensional measurements will be performed on injected and non-injected lesions at the indicated time points in the study calendar.
- Determine progression free survival at 12, 24, and 36 months in treated study subjects. [ Time Frame: 12, 24 and 36 months ]Up to 5 visible deep measureable lesions will be designated as Target Lesions (index lesions)
- Determine overall survival (OS) in treated study subjects. [ Time Frame: Up to 36 months ]Survival and disease control/progression-free survival (PFS) will be estimated using Kaplan-Meir curves.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423863
|United States, Maryland|
|Chevy Chase RCCA|
|Chevy Chase, Maryland, United States, 20815|
|Dermatologic Surgery Center Washington DC|
|Chevy Chase, Maryland, United States, 20815|
|Bay Hematology Oncology|
|Easton, Maryland, United States, 2160l|
|United States, Missouri|
|University of Missouri School of Medicine|
|Columbia, Missouri, United States, 65211-0001|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Nina Bhardwaj, MD, PhD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||David H Smith, MD||Bay Hematology Oncology|
|Principal Investigator:||Kevin Staveley-O'Carroll, MD||University Missouri|
|Principal Investigator:||Frederick P Smith, MD||Chevy Chase, RCCA|