Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1
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ClinicalTrials.gov Identifier: NCT03721679 |
Recruitment Status :
Terminated
(Recruiting target patients is intermittent making it impracticable to enroll the required study sample. The administrative responsibilities have been met with extraordinary challenges. Current funding does not match the incurring costs.)
First Posted : October 26, 2018
Last Update Posted : February 1, 2021
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | October 1, 2018 | |||||||||
First Posted Date ICMJE | October 26, 2018 | |||||||||
Last Update Posted Date | February 1, 2021 | |||||||||
Actual Study Start Date ICMJE | September 25, 2018 | |||||||||
Actual Primary Completion Date | January 26, 2021 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Tumor assessment [ Time Frame: 6 month timepoint compared to baseline ] Response and progression will be evaluated in this study. Tumor Response will be assessed by the RECIST 1.1 Criteria. Response is defined as CR, PR or SD over a period of at least 4 weeks. Changes in the sum of the two largest perpendicular diameters (SPD) of the tumor lesions, or the shortest diameter in the case of malignant lymph nodes are used in the RECIST 1.1 criteria. Study subjects with progressive disease will be evaluated to determine whether the progression causes symptoms and/or functional decline and study subjects with non-clinically relevant progression of disease may remain on study at the investigator's discretion.
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Original Primary Outcome Measures ICMJE |
Tumor assessment [ Time Frame: 6 month timepoint only, compared to baseline ] 2) To evaluate therapeutic efficacy in treated study subjects as assessed by Disease Control (CR, PR, or SD) as defined by the Immune-related Response Criteria (irRC)
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Change History | ||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1 | |||||||||
Official Title ICMJE | Poly-ICLC (Hiltonol®) Plus Anti-PD1 or Anti-PD-L1 in Unresectable Solid Cancers An Adaptive Phase I/II Clinical Pilot Study | |||||||||
Brief Summary | 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) |
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Detailed Description | This research study is a PhaseI/II clinical trial investing a combination of targeted therapies as possible treatment for advanced solid cancers FDA has not yet approved Poly-ICLC as treatment for diseases in this study Pembrolizumab, Nivolumab, Atezolizumab, Cemiplimab and Durvalumab are now FDA approved for certain patients with multiple cancer types. The study is designed to evaluate the safety of intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®) in combination with Anti-PD-1 or Anti-PD-L1 for treatment of study subjects with advanced solid cancers. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: The study is largely a signal-finding exercise to determine if there is an immune and/or clinical response to the addition of poly-ICLC to aPD-1 or aPDL-1 therapy, as predicted by preclinical models. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Solid Cancer | |||||||||
Intervention ICMJE | Biological: Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months
Same as above
Other Name: Same as above
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Study Arms ICMJE | 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:
Intervention: Biological: Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Terminated | |||||||||
Actual Enrollment ICMJE |
7 | |||||||||
Original Estimated Enrollment ICMJE |
60 | |||||||||
Actual Study Completion Date ICMJE | January 26, 2021 | |||||||||
Actual Primary Completion Date | January 26, 2021 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03721679 | |||||||||
Other Study ID Numbers ICMJE | ONC2018-001 | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Oncovir, Inc. | |||||||||
Study Sponsor ICMJE | Oncovir, Inc. | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Oncovir, Inc. | |||||||||
Verification Date | December 2020 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |