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
Public ClinicalTrials.gov record NCT03017820. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03017820
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 99 participants
Conditions and interventions
Conditions
- B-Cell Non-Hodgkin Lymphoma
- Histiocytic and Dendritic Cell Neoplasm
- Myelodysplastic Syndrome
- Previously Treated Myelodysplastic Syndrome
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Anaplastic Large Cell Lymphoma
- Recurrent Angioimmunoblastic T-Cell Lymphoma
- Recurrent Mycosis Fungoides
- Recurrent Plasma Cell Myeloma
- Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Recurrent T-Cell Non-Hodgkin Lymphoma
- Refractory Acute Myeloid Leukemia
- Refractory Anaplastic Large Cell Lymphoma
- Refractory Angioimmunoblastic T-Cell Lymphoma
- Refractory Mycosis Fungoides
- Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Refractory Plasma Cell Myeloma
- Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Refractory T-Cell Non-Hodgkin Lymphoma
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Bone Marrow Biopsy Procedure
- Computed Tomography Procedure
- Cyclophosphamide Drug
- Positron Emission Tomography Procedure
- Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter Biological
- Single Photon Emission Computed Tomography Procedure
- Cemiplimab Biological
- Ruxolitinib Drug
- Nivolumab Biological
- Multigated Acquisition Scan Procedure
- Echocardiography Test Procedure
- Bone Marrow Aspiration Procedure
Procedure · Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2017
- Primary completion
- Dec 30, 2028
- Completion
- Mar 31, 2032
- Last update posted
- Jun 9, 2026
2017 – 2032
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Recruiting |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03017820, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 9, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03017820 live on ClinicalTrials.gov.