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").
1. 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.
2. 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".
3. 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.
4. 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Celldex Therapeutics Merck Sharp & Dohme Corp.
Treatments:
Carboxymethylcellulose Sodium Flt3 ligand protein Pembrolizumab Poly I-C Poly ICLC