Metastatic Endometrial CarcinomaPhase 1NCT03120624
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer
A Phase 1 study testing Biopsy, Computed Tomography and Fluorine F 18 Tetrafluoroborate in people with Metastatic Endometrial Carcinoma and Recurrent Endometrial Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Endometrial Carcinoma, Recurrent Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma
- What is being tested?
- Biopsy, Computed Tomography and Fluorine F 18 Tetrafluoroborate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 1 Jan 2028
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma
- NOTE: histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (NOS)
- NOTE: measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
- Group A only: Largest tumor diameter =< 5 cm
- NOTE: Group B patients have no maximum tumor size
- Absolute neutrophil count (ANC) >= 1500/uL (obtained =< 14 days prior to registration)
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- Platelet count (PLT) >= 100,000/uL (obtained =< 14 days prior to registration)
- Hemoglobin >= 10 g/dL (obtained =< 14 days prior to registration)
- Creatinine =< 2.0 mg/dL (obtained =< 14 days prior to registration)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) (obtained =< 14 days prior to registration)
- NOTE: if baseline liver disease, Child Pugh score not exceeding class A
- Total bilirubin =< 1.5 x ULN (obtained =< 14 days prior to registration)
- International normalized ratio (INR)/prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.4 x ULN (obtained =< 14 days prior to registration) unless on therapeutic warfarin then INR/PT =< 3.5
- Ability to provide written informed consent
- Willingness to return to Mayo Clinic in Rochester, Minnesota for follow-up
- Life expectancy >= 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Willingness to provide mandatory biological specimens for research purposes
- Prior therapy:
- Any number of prior chemotherapy regimens and/or targeted therapies and/or prior external beam radiation therapy and/or prior hormonal therapy for endometrial cancer are allowed provided the last treatment was >= 4 weeks prior to registration
- Vaginal brachytherapy may have been administered at any time prior to registration
Who cannot join
- Availability of and patient acceptance of curative therapy
- Active infection requiring treatment, including any active viral infection, =< 5 days prior to registration
- Active or latent tuberculosis or hepatitis
- Known untreated or symptomatic brain metastases
- Any of the following prior therapies:
- Chemotherapy < 4 weeks prior to registration
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- Targeted biologic therapy < 4 weeks prior to registration
- Immunotherapy < 4 weeks prior to registration
- Any viral or gene therapy prior to registration
- External beam radiotherapy < 4 weeks prior to registration
- NOTE: Vaginal brachytherapy may be performed at any time prior to registration
- New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or uncontrolled current cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
- Active central nervous system (CNS) disorder or seizure disorder or known CNS disease or neurologic symptomatology
- Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression
- History of hepatitis B or C or chronic hepatitis
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation)
- Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids
- Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant persons or persons of reproductive ability who are unwilling to use effective contraception
- Nursing persons
- Any other pathology or condition that the principal investigator deems to negatively impact treatment safety
- Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) > grade 1 at the time of registration
- Receipt of a live virus vaccine =< 2 months prior to registration
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb), in Patients With Metastatic or Recurrent Endometrial Cancer
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS with ruxolitinib phosphate may work better in treating patients with endometrial cancer compared to VSV-hIFNbeta-NIS alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the optimal dose schedule, safety and tolerability as measured by the incidence of significant toxicity of VSV-hIFNbeta-NIS in immunocompetent patients with metastatic and/or recurrent endometrial cancer (EC).
SECONDARY OBJECTIVES:
- To determine the toxicity profile of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib phosphate [ruxolitinib]).
II. To determine the time course of viral gene expression and virus elimination, and the biodistribution of virally infected cells at various times points after infection with VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib) using fluorine F18 tetrafluoroborate (TFB)-positron emission tomography (PET) imaging.
III. To assess virus replication, viremia; viral shedding in urine and respiratory secretions; and virus persistence after intravenous (IV) administration of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib).
IV. To monitor humoral responses to the injected virus. V. To estimate the tumor response rate and overall survival.
CORRELATIVE OBJECTIVES:
- To determine the pharmacokinetic (PK) profile of VSV-IFNbeta-NIS in patients with EC by measurement of VSV-IFNbeta-NIS in blood by reverse transcriptase polymerase chain reaction (RT-PCR).
II. To characterize the pharmacodynamics (PD) of VSV-IFNbeta-NIS by way of measuring serum interferon-beta and also VSV-RT-PCR of VSV-IFNbeta-NIS listed above.
III. Assess CD8+ T cell (both general and VSV-IFNbeta-NIS specific) and natural killer (NK) cell responses.
IV. Gene expression analysis pre- and post-virotherapy. V. Evaluate transcription of interferon mediated genes (protein kinase R, the death receptor-TRAIL, 2'-5' oligoadenylate/RNAse L proteins, heat shock proteins [Hsp 60/70/90], major histocompatibility class antigens and IRF-7).
VI. Assess presence of VSV in tumor and normal tissues subsequent to administration of IV VSV-IFNbeta-NIS.
OUTLINE: This is a dose-escalation study of VSV-hIFNbeta-NIS. Patients are randomized to 1 of 2 arms.
ARM A (EFFECTIVE AS OF 1/10/2023, GROUP A IS PERMANENTLY CLOSED TO ACCRUAL): Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV, fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo computed tomography (CT) throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
ARM B: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at day 29, every 3 months until disease progression and then every 6 months for up to 5 years.
- Conditions
- Metastatic Endometrial Carcinoma, Recurrent Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Endometrial Mixed Cell Adenocarcinoma
- Being tested
- Biopsy, Computed Tomography, Fluorine F 18 Tetrafluoroborate, Pharmacological Study, Positron Emission Tomography
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Biopsy Type, BIOPSY_TYPE, Bx
Undergo image-guided biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo CT
Fluorine F 18 TetrafluoroborateOther
Also called 18F-Tetrafluoroborate, 18F-TFB
Given IV
Correlative studies
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo TFB-PET
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide SymporterBiological
Also called Oncolytic VSV-hIFNbeta-NIS, Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter, Voyager-V1, VSV-expressing hIFNb and NIS
Given IV
Ruxolitinib PhosphateDrug
Also called 1092939-17-7, INCB-18424 Phosphate, Jakafi, Jakavi
Given PO
Technetium Tc-99m Sodium PertechnetateDrug
Also called Pertscan-99m, Sodium Pertechnetate (Na99mtco4), Tc 99m Generator, Ultra-Technekow FM
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo mouth rinse, buccal swab, urine, and blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy) | Experimental | Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Receives: Procedure: Biopsy; Procedure: Computed Tomography; Other: Fluorine F 18 Tetrafluoroborate; Other: Pharmacological Study; Procedure: Positron Emission Tomography; Biological: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter; Drug: Technetium Tc-99m Sodium Pertechnetate; Procedure: Biospecimen Collection |
| Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) | Experimental | Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Receives: Procedure: Biopsy; Procedure: Computed Tomography; Other: Fluorine F 18 Tetrafluoroborate; Other: Pharmacological Study; Procedure: Positron Emission Tomography; Biological: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter; Drug: Ruxolitinib Phosphate; Drug: Technetium Tc-99m Sodium Pertechnetate; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Experienced a Dose-limiting Toxicity (DLT)
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLT is defined as one of the following events deemed related to the study drug; Grade 2+ allergic reaction or cytokine release syndrome, or any grade 3+ with the exception of lymphopenia or other related events (e.g., anemia, white blood cell count decreased), which will not be considered a dose limiting toxicity. Grade ≥3 flu-like symptoms, fever, nausea, vomiting, dehydration, diarrhea, headache, myalgia, fatigue, ALT increased, or AST increased, will also not be considered as a dose limiting toxicity as they are anticipated toxicities of treatment.
Measured: 28 days
Secondary outcomes (6)
Incidence of Adverse Events
Graded according to the NCI CTCAE version 4. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals.
Measured: Up to 1 year
Number of Clinical Responses
Defined as complete response, partial response, or stable disease assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized by simple descriptive summary statistics across all patients in each group as well as by dose level and primary type of cancer (EC).
Measured: Up to 1 year
Viral Replication and Shedding in Blood, Throat Washings, Urine, and Buccal Swabs Assessed Via Quantitative Reverse Transcriptase Polymerase Chain Reaction
Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations with other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).
Measured: Up to 1 year
Count of Patients With Positive Virus Spread.
Virus spread will be ssessed via single-photon emission computed tomography/computed tomography and will be correlated with tumor distribution.
Measured: 10 days
Time Until Treatment Related Grade 3+ Toxicity
Graded according to the NCI CTCAE version 4. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.
Measured: Up to 1 year
Time Until Hematologic Nadirs (White Blood Cells, Absolute Neutrophil Count, Platelets)
Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start15 Sep 2017
- Primary completion29 Aug 2023
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jamie N. Bakkum-Gamez, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120624
- Sponsor's protocol ID
- MC1562
- Other IDs
- NCI-2017-00615, MC1562, R01CA207240, 15-007000
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2017
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb), in Patients With Metastatic or Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03120624
- Acronym / sponsor ID
- MC1562
- Conditions
- Metastatic Endometrial Carcinoma, Recurrent Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Endometrial Mixed Cell Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 19 Apr 2017 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS with ruxolitinib phosphate may work better in treating patients with endometrial cancer compared to VSV-hIFNbeta-NIS alone.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the optimal dose schedule, safety and tolerability as measured by the incidence of significant toxicity of VSV-hIFNbeta-NIS in immunocompetent patients with metastatic and/or recurrent endometrial cancer (EC).
SECONDARY OBJECTIVES:
- To determine the toxicity profile of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib phosphate [ruxolitinib]).
II. To determine the time course of viral gene expression and virus elimination, and the biodistribution of virally infected cells at various times points after infection with VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib) using fluorine F18 tetrafluoroborate (TFB)-positron emission tomography (PET) imaging.
III. To assess virus replication, viremia; viral shedding in urine and respiratory secretions; and virus persistence after intravenous (IV) administration of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib).
IV. To monitor humoral responses to the injected virus. V. To estimate the tumor response rate and overall survival.
CORRELATIVE OBJECTIVES:
- To determine the pharmacokinetic (PK) profile of VSV-IFNbeta-NIS in patients with EC by measurement of VSV-IFNbeta-NIS in blood by reverse transcriptase polymerase chain reaction (RT-PCR).
II. To characterize the pharmacodynamics (PD) of VSV-IFNbeta-NIS by way of measuring serum interferon-beta and also VSV-RT-PCR of VSV-IFNbeta-NIS listed above.
III. Assess CD8+ T cell (both general and VSV-IFNbeta-NIS specific) and natural killer (NK) cell responses.
IV. Gene expression analysis pre- and post-virotherapy. V. Evaluate transcription of interferon mediated genes (protein kinase R, the death receptor-TRAIL, 2'-5' oligoadenylate/RNAse L proteins, heat shock proteins [Hsp 60/70/90], major histocompatibility class antigens and IRF-7).
VI. Assess presence of VSV in tumor and normal tissues subsequent to administration of IV VSV-IFNbeta-NIS.
OUTLINE: This is a dose-escalation study of VSV-hIFNbeta-NIS. Patients are randomized to 1 of 2 arms.
ARM A (EFFECTIVE AS OF 1/10/2023, GROUP A IS PERMANENTLY CLOSED TO ACCRUAL): Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV, fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo computed tomography (CT) throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
ARM B: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at day 29, every 3 months until disease progression and then every 6 months for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy) | Experimental | Procedure: Biopsy, Procedure: Computed Tomography, Other: Fluorine F 18 Tetrafluoroborate, Other: Pharmacological Study, Procedure: Positron Emission Tomography, Biological: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter, Drug: Technetium Tc-99m Sodium Pertechnetate, Procedure: Biospecimen CollectionPatients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. |
| Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) | Experimental | Procedure: Biopsy, Procedure: Computed Tomography, Other: Fluorine F 18 Tetrafluoroborate, Other: Pharmacological Study, Procedure: Positron Emission Tomography, Biological: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter, Drug: Ruxolitinib Phosphate, Drug: Technetium Tc-99m Sodium Pertechnetate, Procedure: Biospecimen CollectionPatients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma
- Group A only: Largest tumor diameter =< 5 cm
- Absolute neutrophil count (ANC) >= 1500/uL (obtained =< 14 days prior to registration)
- Platelet count (PLT) >= 100,000/uL (obtained =< 14 days prior to registration)
- Hemoglobin >= 10 g/dL (obtained =< 14 days prior to registration)
Key exclusion criteria (24 listed)
- Availability of and patient acceptance of curative therapy
- Active infection requiring treatment, including any active viral infection, =< 5 days prior to registration
- Active or latent tuberculosis or hepatitis
- Known untreated or symptomatic brain metastases
- Any of the following prior therapies:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: Biopsy Type, BIOPSY_TYPE, BxUndergo image-guided biopsy | Procedure or surgery | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo CT | Procedure or surgery | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Fluorine F 18 TetrafluoroborateAlso: 18F-Tetrafluoroborate, 18F-TFBGiven IV | Other | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Pharmacological StudyCorrelative studies | Other | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo TFB-PET | Procedure or surgery | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide SymporterAlso: Oncolytic VSV-hIFNbeta-NIS, Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter, Voyager-V1, VSV-expressing hIFNb and NISGiven IV | Biological | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Ruxolitinib PhosphateAlso: 1092939-17-7, INCB-18424 Phosphate, Jakafi, JakaviGiven PO | Drug | Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Technetium Tc-99m Sodium PertechnetateAlso: Pertscan-99m, Sodium Pertechnetate (Na99mtco4), Tc 99m Generator, Ultra-Technekow FMGiven IV | Drug | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo mouth rinse, buccal swab, urine, and blood sample collection | Procedure or surgery | Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy) |
Primary outcome
Participants Who Experienced a Dose-limiting Toxicity (DLT)
Time frame: 28 days
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLT is defined as one of the following events deemed related to the study drug; Grade 2+ allergic reaction or cytokine release syndrome, or any grade 3+ with the exception of lymphopenia or other related events (e.g., anemia, white blood cell count decreased), which will not be considered a dose limiting toxicity. Grade ≥3 flu-like symptoms, fever, nausea, vomiting, dehydration, diarrhea, headache, myalgia, fatigue, ALT increased, or AST increased, will also not be considered as a dose limiting toxicity as they are anticipated toxicities of treatment.
6 secondary outcomes
Incidence of Adverse Events
Time frame: Up to 1 year
Number of Clinical Responses
Time frame: Up to 1 year
Viral Replication and Shedding in Blood, Throat Washings, Urine, and Buccal Swabs Assessed Via Quantitative Reverse Transcriptase Polymerase Chain Reaction
Time frame: Up to 1 year
Count of Patients With Positive Virus Spread.
Time frame: 10 days
Time Until Treatment Related Grade 3+ Toxicity
Time frame: Up to 1 year
Time Until Hematologic Nadirs (White Blood Cells, Absolute Neutrophil Count, Platelets)
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie N. Bakkum-Gamez, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biopsy, Computed Tomography and Fluorine F 18 Tetrafluoroborate in people with Metastatic Endometrial Carcinoma and Recurrent Endometrial Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Who Experienced a Dose-limiting Toxicity (DLT) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.