Clinical Trial Goal
To find out:
- The highest dose of poly ICLC that’s safe to give with radiation, CDX-301 and pembrolizumab
- If the combination of radiation, CDX-301, poly ICLC and pembrolizumab is safe and works well to treat slow-growing NHL
You may be able to join this trial if you:
- Are 18 years old or older
- Have a slow-growing NHL. Some examples are:
- Chronic lymphocytic leukemia (CLL)
- Cutaneous T-cell lymphoma (CTCL)
- Follicular lymphoma that is grade 1, 2, or 3a. Your doctor can tell you what grade your lymphoma is
- Mantle cell lymphoma (MCL)
- Marginal zone B-cell lymphoma
- Small lymphocytic lymphoma (SLL)
- Other slow-growing NHL
- Waldenström's macroglobulinemia
- Do not have diffuse large B-cell lymphoma (DLBCL) or grade 3A follicular lymphoma
- Do not have untreated lymphoma in your brain or spinal cord
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
CDX-301 is a drug that doctors think can stimulate your immune system.
Poly ICLC is a vaccine designed to stimulate your immune system to kill cancer cells.
Pembrolizumab is a checkpoint inhibitor that targets PD-1 on certain cells.
You’ll get:
Poly ICLC is a vaccine designed to stimulate your immune system to kill cancer cells.
Pembrolizumab is a checkpoint inhibitor that targets PD-1 on certain cells.
You’ll get:
- Low-dose Radiation therapy – Given 2 times
- CDX-301 – Given as a shot under the skin 1 time
- Poly ICLC – Given as a shot into the tumor
- Pembrolizumab – Given as intravenous (IV) infusions 1 time every 3 weeks. The infusion takes about 30 minutes
You’ll have scans to see how well treatment is working. The clinical trial doctors will check your health for 6 months.
The Food and Drug Administration (FDA) has not yet approved poly ICLC or CDX-301. The FDA has approved pembrolizumab to treat some types of lymphoma. Using these drugs together to treat slow-growing NHL is new and unproven.
Locations
Icahn School of Medicine at Mount SinaiRECRUITING
New York, New York
Sponsors
collaborator: Merck Sharp & Dohme LLC, collaborator: Celldex Therapeutics, lead: Icahn School of Medicine at Mount Sinai
