Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06324240
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Early Stage Triple-Negative Breast Carcinoma
  • Locally Advanced Triple-Negative Breast Carcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Recurrent Breast Carcinoma
  • Unresectable Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Vaccine Therapy — BIOLOGICAL
    Given TMV vaccine ID

Study Details

This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.

Key Dates

Start date
Dec 2, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ia (TMV vaccine)
    Patients receive TMV vaccine ID at weeks 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.
  • Experimental: Phase Ib Arm A ( TMV vaccine, pembrolizumab)
    Patients receive TMV vaccine ID at weeks 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV on day 1. Treatment with pembrolizumab repeats every 21 days for 6-9 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: Phase Ib Arm B ( TMV vaccine, ipilimumab)
    Patients receive TMV vaccine ID at weeks 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV on day 1. Treatment with ipilimumab repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events (Phase Ia) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Deborah Omoyege
[email protected]
Keerthi Gogineni, MD, MSHP (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Deborah Omoyege
[email protected]
Keerthi Gogineni, MD, MSHP (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Deborah Omoyege
[email protected]
Keerthi Gogineni, MD, MSHP (PRINCIPAL_INVESTIGATOR)
Grady Health SystemAtlantaGeorgia30303
Deborah Omoyege
[email protected]
Keerthi Gogineni, MD, MSHP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAGrady Health System· Atlanta, GA

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