NCT07199413

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain Metastases
• Leptomeningeal Metastasis

Interventions

Type	Name	Description
BIOLOGICAL	SV-BR-1-GM Vaccine	\~20 X 10\^6 cells across 4 injection sites
DRUG	Cyclophosphamide	300 mg/m\^2 Intravenous
DRUG	Pembrolizumab	200 mg/m\^2 Intravenous
DRUG	Interferon	0.18 mcg subcutaneous

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2025-09-30
• Last updated: 2025-09-30

Regulatory

• FDA-regulated drug study