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Combination Study of SV-BR-1-GM With Retifanlimab

NCT03328026 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

SV-BR-1-GM

SV-BR-1-GM inoculation intradermally at 4 sites.

DRUG

Low dose cyclophosphamide

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation.

DRUG

Interferon Inoculation

Post-inoculation low dose Interferon into the vaccination sites \~2 days after SV-BR-1-GM inoculation.

DRUG

retifanlimab

retifanlimab 375mg administered as an intravenous infusion over 30-60 minutes every 3 weeks per randomization

Sponsors & Collaborators

  • LumaBridge

    collaborator INDUSTRY

  • BriaCell Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

  • George E Peoples, MD, FACS · LumaBridge LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2026-03-24
Completion
2026-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03328026 on ClinicalTrials.gov