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

NCT07199413 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IIT-KAMARAJU-ASTRO
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Brain Metastases; Leptomeningeal Metastasis

Keywords

solid tumor patients; CNS Metastases; SV-BR-1-GM Vaccine; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

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

• Study therapy duration

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

  6 months

Study Arms (1)

Vaccine and Study Drugs

EXPERIMENTAL

Biological: SV-BR-1-GM Vaccine; Drug: Cyclophosphamide; Drug: Pembrolizumab; Drug: Interferon

Interventions

SV-BR-1-GM Vaccine BIOLOGICAL

\~20 X 10\^6 cells across 4 injection sites

Vaccine and Study Drugs

Cyclophosphamide DRUG

300 mg/m\^2 Intravenous

Also known as: Cytoxan

Vaccine and Study Drugs

Pembrolizumab DRUG

200 mg/m\^2 Intravenous

Also known as: Keytruda

Vaccine and Study Drugs

Interferon DRUG

0.18 mcg subcutaneous

Also known as: Sylatron

Vaccine and Study Drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

MeSH Terms

Conditions

Brain Neoplasms; Meningeal Carcinomatosis

Interventions

Cyclophosphamide; pembrolizumab; Interferons; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share