OncoMatch/Clinical Trials/NCT03017820
A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
Is NCT03017820 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for b-cell non-hodgkin lymphoma.
Treatment: Cyclophosphamide · Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter · Cemiplimab · Ruxolitinib · Nivolumab — This phase I trial studies the best dose and side effects of the VSV-hIFNβ-NIS vaccine with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab in treating patients with multiple myeloma, acute myeloid leukemia or lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). VSV-IFNβ-NIS is a modified version of the vesicular stomatitis virus (also called VSV). This virus can cause infection and when it does it typically infects pigs, cattle, or horses but not humans. The VSV used in this study has been altered by having two extra genes (pieces of DNA) added. The first gene makes a protein called NIS that is inserted into the VSV. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body (which organs). The second addition is a gene for human interferon beta (β) or hIFNβ. Interferon is a natural anti-viral protein, intended to protect normal healthy cells from becoming infected with the virus. VSV is very sensitive to the effect of interferon. Many tumor cells have lost the capacity to either produce or respond to interferon. Thus, interferon production by tumor cells infected with VSV-IFNβ-NIS will protect normal cells but not the tumor cells. The VSV with these two extra pieces is referred to as VSV-IFNβ-NIS. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, and cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab may be safe and effective in treating patients with recurrent peripheral T-cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunomodulatory imide drug — Multiple myeloma
Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID)
Must have received: proteasome inhibitor — Multiple myeloma
Multiple myeloma (MM) previously treated with ... a proteosome inhibitor
Must have received: alkylating agent — Multiple myeloma
Multiple myeloma (MM) previously treated with ... an alkylating agent
Lab requirements
Blood counts
MM: ANC ≥ 1000/uL, PLT ≥ 100,000/uL, Hgb ≥ 8.5 g/dl; AML: PLT ≥ 10,000/uL (transfusion allowed), Hgb ≥ 7.5 g/dl, no ANC restriction; TCL/BCL: ANC ≥ 1,000/uL, PLT ≥ 100,000/uL, Hgb ≥ 8.5 g/dl; HCN: ANC ≥ 1,000/uL, PLT ≥ 100,000/uL, Hgb ≥ 8.0 g/dl
Kidney function
Creatinine ≤ 2.0 mg/dL
Liver function
ALT and AST ≤ 2 x ULN; direct bilirubin ≤ 1.5 x ULN; Child Pugh score not exceeding class A if baseline liver disease
Cardiac function
INR/PT and aPTT ≤ 1.5 x ULN; NYHA class III or IV, symptomatic coronary artery disease, or known cardiac arrhythmias (atrial fibrillation or SVT) [excluded]
ALT and AST ≤ 2 x ULN; creatinine ≤ 2.0 mg/dL; direct bilirubin ≤ 1.5 x ULN; INR/PT and aPTT ≤ 1.5 x ULN; Child Pugh score not exceeding class A if baseline liver disease; MM: ANC ≥ 1000/uL, PLT ≥ 100,000/uL, Hgb ≥ 8.5 g/dl; AML: PLT ≥ 10,000/uL (transfusion allowed), Hgb ≥ 7.5 g/dl, no ANC restriction; TCL/BCL: ANC ≥ 1,000/uL, PLT ≥ 100,000/uL, Hgb ≥ 8.5 g/dl; HCN: ANC ≥ 1,000/uL, PLT ≥ 100,000/uL, Hgb ≥ 8.0 g/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03017820 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received immunomodulatory imide drug and proteasome inhibitor.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify