Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1
- Conditions
- Solid Cancer
- Interventions
- Biological: Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months
- Registration Number
- NCT03721679
- Lead Sponsor
- Oncovir, Inc.
- 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)
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Poly-ICLC treatment combination aPD-1or aPD-1L1 Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months 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: 1. Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM twice a week with a 48-72 hour interval between the two injections, AND 2. ONLY 1 of the following regimens will be administered, per manufacturer's dosing and clinical oncologist's discretion as follows: * Nivolumab (Opdivo), OR * Pembrolizumab (Keytruda), OR * Cemiplimab (Libtayo) OR * Atezolizumab (Tecentriq) OR * Durvalumab (Imfinzi) Follow up: After completion of treatment subjects may be contacted by telephone at least twice over 12 months, or longer with patient consent, in order to inquire on their health status (e.g., in remission, progressive disease, on new cancer treatment).
- Primary Outcome Measures
Name Time Method Tumor assessment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Chevy Chase RCCA
🇺🇸Chevy Chase, Maryland, United States
Bay Hematology Oncology
🇺🇸Easton, Maryland, United States