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Brain MetastasesPhase 1NCT07199413

Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy

A Phase 1 study testing SV-BR-1-GM Vaccine, Cyclophosphamide and Pembrolizumab in people with Brain Metastases and Leptomeningeal Metastasis, run by Medical College of Wisconsin.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a prospective, single-center, phase 1 basket trial that will evaluate the safety and feasibility of administering SV-BR-1-GM in combination with pembrolizumab to solid tumor oncology patients over nine cycles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases, Leptomeningeal Metastasis
What is being tested?
SV-BR-1-GM Vaccine, Cyclophosphamide and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jun 2026to 1 Apr 2029
Phase
Phase 1
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Subject has a prior diagnosis of central nervous system (CNS) metastases per institutional standard of care and/or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria on imaging.
  • Subject has disease progression of CNS metastases (brain and/or leptomeningeal metastases (LMD) ) with progression on ≥ 1 line of standard of care therapy.
  • Patients should have at least one metastasis approved by the research team that meets the following size requirements:
  • o Diagnosis and treatment response to measurable CNS and LMD will be per institutional and/or RANO-BM criteria modified to include the cut off point of 0.5 cm or higher.
  • Patients with recurrent and or progressive symptomatic or asymptomatic brain lesions and >0.5 cm and twice the magnetic resonance imaging (MRI) slice thickness are allowed.
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  • Any recurrent or progressive brain lesions > 3 cm in size and or causing symptoms must be evaluated by the study team for SRC and or whole brain radiation therapy (WBRT) prior to study entry.
  • Patients with recurrent brain lesions that are not treatable with local therapy or WBRT are eligible.
  • An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted; an interval of at least 4 weeks or 5 half-lives (whichever is sorter) after the last cytotoxic, targeted, immunotherapeutic or investigational agent is permitted (prior to the start of DC vaccine).
  • Patients should have recovered from the AEs of prior therapy to baseline or Grade ≤ 1.
  • Patients with recurrent or progressive LMD are eligible.
  • Prior surgical resection of the brain metastases is allowed; patients must recover for at least four weeks prior to study enrollment.
  • Patients with extracranial disease are eligible as long as no signs of visceral crisis.
  • Prior immunotherapy is allowed.
  • No need for steroids for at least two weeks.
  • Patients who recently started steroids should have completed tapering to be eligible.
  • Patients who have been on chronic steroids are eligible as long as they are maintained on a dose of ≤ 10 mg of prednisone or equivalent.
  • Tumor not impinging on the middle cerebral artery/speech-motor strip.
  • Patients who undergo any other surgical procedures (other than SRS) must have recovered for at least 3-4 weeks before study entry.
  • Subject has a life expectancy of ≥ 12 weeks.
  • ECOG 0-2.
  • Preserved organ function.
  • ANC ≥ 1,000/µl
  • Platelets ≥ 10,000 µl
  • Hemoglobin ≥ 8 gm/dL
  • Bilirubin ≤ 1.5 mg/dL; those with Gilbert syndrome may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN.
  • Creatinine clearance ≥ 50 mL/min
  • AST, ALT ≤ 2.5 times institutional upper limit
  • ALP ≤ 2.5 × institutional upper limit, with the exception that ALP of < 5 x ULN is acceptable in patients with elevated ALP due to bone metastases (in the absence of liver metastases).
  • Patients with lymphopenia are eligible at the discretion of the treating provider.
  • Female subjects must meet one of the following:
  • Postmenopausal for at least one year before enrollment, or surgically sterile (i.e., undergone bilateral oophorectomy).
  • Premenopausal is defined as someone who has had menses at any time in the preceding 12 months. Premenopausal women who are eligible for this trial will require a GnRH analogue and treating physician, per institutional guidelines, may choose to monitor the ovarian function with laboratory tests (FSH/LH/Estradiol) to ensure a complete menopausal status with cessation of menses.
  • Note: Pregnancy test should be administered per institutional guidelines.
  • Male patients must be willing to abstain from heterosexual activity and/or use a condom during treatment and three months after treatment discontinuation.
  • Willing to provide blood for biomarker assessments.
  • Optional CSF, when appropriate, for biomarker assessments (at the discretion of treating physician).
  • Ability to understand a written informed consent document, and the willingness to sign it.

Who cannot join

  • History of allergic reactions or intolerance to immunotherapy.
  • History of active or untreated infection, such as chronic untreated infections, HIV, Hepatitis B, Hepatitis C, or tuberculosis.
  • History of active inflammatory or autoimmune disease (granulomatosis, polyangiitis, Graves' disease, rheumatoid arthritis, polyphisitis, uveitis, etc.), except for the following.
  • Vitiligo; alopecia
  • Hypothyroidism: stable on replacement therapy
  • Chronic skin disease that doesn't require steroid therapy.
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  • Active celiac disease or inflammatory bowel disease
  • Presence of severe neurological symptoms and unable to participate in the study due to acute decompensation.
  • History of severe brain injury.
  • History of last dose of antineoplastic therapy ≤ 7 days prior to the first dose of study drug. If sufficient wash-out time has not occurred (defined as 5 half-lives of the prior antineoplastic therapy), a longer wash-out may be needed, as suggested by the study team.
  • Patients with myelodysplastic syndrome (MDS), leukemia, or active blood disorders.
  • Patients with prior history of poorly controlled diabetes, lung disease, primary immunodeficiency syndromes.
  • Severe cardiac disease as determined by the treating providers.
  • Life expectancy <12 weeks.
  • Acute spinal cord compression, unless considered to have received definitive treatment for this and clinical evidence of stable disease for at least 28 days.
  • Active treatment with prednisone >10 mg or equivalent steroid (e.g., >1.5 mg dexamethasone) per day and/or other immunosuppressive therapies (e.g., interferon, azathioprine, mycophenolate).
  • Presence of secondary malignancies (chronic lymphocytic leukemia [CLL], and other hematological or solid tumor malignancies), with the exception of in situ disease (ductal carcinoma in situ [DCIS], lobular carcinoma in situ [LCIS], cervical intraepithelial neoplasia [CIN], squamous cell and basal cell cancer, or remote history of successfully treated melanoma).
  • Active participation in other clinical trials evaluating an active investigational drug within the past four weeks.
  • Unresolved toxicities of NCI CTCAE Grade ≥ 2 such as neurotoxicity, cardiotoxicity, myelotoxicity, gastrointestinal, or others.
  • Patients who received prior immune checkpoint inhibitors (CPIs) and have not recovered from Grade ≥ 2 AEs related to CPIs.
  • Women of childbearing potential who do not agree to precautions outlined in the inclusion criteria or having positive pregnancy tests.
  • Men who are sexually active and not willing to use effective contraceptives (e.g., condoms) during and 3 months after treatment.
  • Women who are pregnant or nursing.
  • Severe mental illness per physician's assessment.

About this study

Official title: Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy: A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases

This is a prospective, single-center, phase 1 basket trial that will evaluate the safety and feasibility of administering SV-BR-1-GM in combination with pembrolizumab to solid tumor oncology patients over nine cycles.

Read the detailed description

This prospective, single-site, open-label, single-arm, phase 1 basket trial is designed to evaluate whether a SV-BR-1-GM vaccine and pembrolizumab combination therapy is safe and can be feasibly administered to solid cancer patients with brain metastases who progress on SOC therapy. Secondary objectives will determine the preliminary efficacy of the study regimen, while exploratory measurements will evaluate underlying mechanisms and biomarkers of response using patient biospecimens (peripheral blood and, when available, CSF). A total of 20 solid tumor oncology patients, accrued over a 24-month time period, will be treated with the SV-BR-1-GM vaccine and pembrolizumab over nine three-week cycles.

Being tested
SV-BR-1-GM Vaccine, Cyclophosphamide, Pembrolizumab, Interferon
Keywords
solid tumor patients, CNS Metastases, SV-BR-1-GM Vaccine, Immunotherapy
Medical subject headings
Brain Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SV-BR-1-GM VaccineBiological

    ~20 X 10^6 cells across 4 injection sites

  • CyclophosphamideDrug

    Also called Cytoxan

    300 mg/m^2 Intravenous

  • PembrolizumabDrug

    Also called Keytruda

    200 mg/m^2 Intravenous

  • InterferonDrug

    Also called Sylatron

    0.18 mcg subcutaneous

Study groups in NCT07199413
Study groupRoleWhat they receive
Vaccine and Study DrugsExperimentalNot described
Receives: Biological: SV-BR-1-GM Vaccine; Drug: Cyclophosphamide; Drug: Pembrolizumab; Drug: Interferon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grade 3 or higher adverse events

    The number of grade 3 or higher adverse events (AEs). AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse (CTCAE), version 5.0.

    Measured: 30 days after the beginning of study therapy, 9 months after the beginning of study therapy

  2. Study therapy duration

    The number of subjects who complete six months of the investigational agent (vaccine).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start15 Jun 2026
  3. Primary completion1 Apr 2029 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Why it stopped: Study never started.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07199413
Sponsor's protocol ID
IIT-KAMARAJU-ASTRO
Status last verified
Jun 2026
First submitted
22 Sep 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SV-BR-1-GM Vaccine, Cyclophosphamide and Pembrolizumab in people with Brain Metastases and Leptomeningeal Metastasis, run by Medical College of Wisconsin.

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 38 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: withdrawn, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Grade 3 or higher adverse events (time frame: 30 days after the beginning of study therapy, 9 months after the beginning of study therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07199413.

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 17 Jun 2026.

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