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

Conditions

• Breast Cancer
• Breast Cancer Metastatic
• Breast Neoplasm
• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SV-BR-1-GM — BIOLOGICAL
  SV-BR-1-GM inoculation intradermally at 4 sites.
• Low dose cyclophosphamide — DRUG
  Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation.
• Interferon Inoculation — DRUG
  Post-inoculation low dose Interferon into the vaccination sites \~2 days after SV-BR-1-GM inoculation.
• retifanlimab — DRUG
  retifanlimab 375mg administered as an intravenous infusion over 30-60 minutes every 3 weeks per randomization

Study Details

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.

Key Dates

Start date

Mar 16, 2018

Status verified

Mar 2026

Primary completion

Mar 24, 2026

Completion

Mar 24, 2026

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: SV-BR-1-GM, retifanlimab combination original sequence
  Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab with cycles every 3 weeks
• Experimental: SV-BR-1-GM, retifanlimab combination alternative sequence
  Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab as follows: Cycle 1: SV-BR-1-GM only Cycle 2: resume retifanlimab on Day 2±1 Cycle 3 and beyond: retifanlimab can be administered on Day -2, Day 0, 1, 2, or 3.

Primary Outcome Measure

Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with SV-BR-1-GM administered in combination with INCMGA00012 (retifanlimab) [Safety] [ Time Frame: Through study completion, an average of 1 year ]

Locations (14)

Find similar trials in Newport Beach, CA

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