Combination Study of SV-BR-1-GM With Retifanlimab
Public ClinicalTrials.gov record NCT03328026. 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
A Phase I/II Study of the SV-BR-1-GM Regimen in Metastatic or Locally Recurrent Breast Cancer Patients in Combination With Retifanlimab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy. Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.
Study identification
- NCT ID
- NCT03328026
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 36 participants
Conditions and interventions
Interventions
- SV-BR-1-GM Biological
- Low dose cyclophosphamide Drug
- Interferon Inoculation Drug
- retifanlimab Drug
Biological · Drug
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
- Mar 16, 2018 (Actual)
- Primary completion
- Mar 24, 2026 (Actual)
- Completion
- Mar 24, 2026 (Actual)
- Last update posted
- Mar 27, 2026
2018 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| University of Miami/Sylvester at Plantation | Plantation | Florida | 33324 | — |
| Carle Cancer Institute | Urbana | Illinois | 61801 | — |
| Cancer Center of Kansas (CCK) | Wichita | Kansas | 67214 | — |
| The Center for Cancer and Blood Disorders a division of American Oncology Partners MD | Bethesda | Maryland | 20817 | — |
| St Vincent-Frontier Cancer Center | Billings | Montana | 59102 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Overlook Medical Center Oncology Research, Atlantic Health System | Summit | New Jersey | 07901 | — |
| Manhattan Hematology Oncology Associates (MHOA) | Manhattan | New York | 10016 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | — |
| Tranquil Clinical Research | Webster | Texas | 77598 | — |
| Hematology-Oncology Associates of Fredericksburg, Inc | Fredericksburg | Virginia | 22408 | — |
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 NCT03328026, 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 Mar 27, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03328026 live on ClinicalTrials.gov.