Vaccination With Flt3L, Radiation, and Poly-ICLC
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|ClinicalTrials.gov Identifier: NCT03789097|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : July 15, 2020
This is a combination of 4 therapies, three of which are used to treat a single "target site" of your cancer (such as a lymph node or a single tumor), and the 4th is given directly into the blood stream (intravenous or "IV").
- Radiation: The target site --lymph node or tumor (the one what will be injected) --will get two small treatments of radiation. Radiation is often times used to shrink and kill tumors in patients with certain types of lymphoma, breast cancer and head and neck cancer, however, the dose of radiation that you will receive --one dose on day one of the clinical trial and one dose on day two --is 10 to 20 time less radiation that you would receive for treatment of these cancers.
- Flt3L/CDX-301 is an immune cell growth factor, similar to white blood cell growth factors (Neupogen or Neulasta) or red blood cell growth factors (EPO or Epogen) that you may have received to help protect your blood cells previously. Flt3L causes your body to make more immune cells, specifically a type of immune cell called "dendritic cells".
- Poly-ICLC is an immune cell activating factor. Its function is to turn on the immune cells that have been brought to the tumor by Flt3L.
- Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to kill your tumor cells. Pembrolizumab is approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with many different types of cancer including head and neck cancer. Pembrolizumab is not FDA approved to treat patients with non-Hodgkin's lymphoma or metastatic breast cancer, as it has not been effective at treating these cancers when used alone. While most people do not have immediate side effects when this medication is given, it has the ability to cause side effects for.
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Metastatic Breast Cancer Head and Neck Squamous Cell Carcinoma||Drug: Pembrolizumab Drug: Flt3L Radiation: Radiation Drug: Poly ICLC||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma|
|Actual Study Start Date :||April 5, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Combination therapy
Vaccination with Flt3L, Radiation, and Poly ICLC combined with Pembrolizumab
200 mg administered as an IV infusion over 30 minutes Q3W
Other Name: Keytruda
an immune cell growth factor. CDX-301 drug product is formulated as a sterile solution intended for single-use parenteral administration. Each vial contains a nominal 2.5 mg/mL CDX-301 protein in a 1 mL volume of buffered solution composed of sodium phosphate and sodium chloride, with a pH of 7.0.
The target site will get 2 small treatments of radiation.
Drug: Poly ICLC
an immune cell activating factor. vials containing 1 ml of 2 mg/mL
Other Name: Hiltonol
- Dose Limiting Toxicity (DLT) [ Time Frame: 63 days ]DLTs recorded and graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03, within DLT evaluation window of 63 days (end of cycle 1 of pembrolizumab) from initiation of in situ vaccine.
- Overall response rate (ORR) [ Time Frame: 6 months ]Overall response rate (ORR) as defined as best response achieved within the first 6 months from initiation of trial. ORR is defined as complete remission (CR) or partial remission (PR) in patients as defined by RECIST v1.1 for MBC and HNSCC or as per the RECIL Criteria for patients with lymphoma, determined by Positron emission tomography-computed tomography (PET/CT) or computed tomography (CT) imaging which occurs at 3 month intervals, with the first imaging 3 months following initiation of Flt3L (D0) +/- 2 weeks.
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): NCT03789097
|Contact: Alexis Mark, MS, CCRC||212-824-7325 ext email@example.com|
|Contact: Martine Van Voorthuysen||(212) 824-7822||Martine.VanVoorthuysen@mssm.edu|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Joshua Brody|
|Principal Investigator:||Joshua Brody, MD||Icahn School of Medicine at Mount Sinai|