Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07694986
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • cDC1 Vaccine — BIOLOGICAL
    Autologous peptide-pulsed cDC1 vaccine administered intrathecally.
  • Trastuzumab — DRUG
    150 mg intrathecal weekly for HER2-positive participants.
  • Nivolumab — DRUG
    50 mg intrathecal every 2 weeks for HER2-negative participants.

Study Details

The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), in combination with trastuzumab or nivolumab to confirm the highest dose of the study treatment that can be given safely to participants with Breast Cancer (BC) with Leptomeningeal Disease (LMD).

Key Dates

First listed
Jul 10, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-In HER2- Cohort
    Participants with HER2-negative breast cancer leptomeningeal disease (TNBC or HR-positive) receive intrathecal HER3-pulsed cDC1 vaccines in combination with IT nivolumab.
  • Experimental: Safety Run-In HER2+ Cohort
    Participants with HER2-positive breast cancer leptomeningeal disease receive intrathecal (IT) HER2/HER3 peptide-pulsed cDC1 vaccines in combination with IT trastuzumab.
  • Experimental: Phase 2 Efficacy Cohort
    Following completion of the safety run-in and confirmation of the RP2D, participants will receive treatment based on HER2 status: HER2-positive participants will receive IT cDC1 vaccines plus IT trastuzumab. HER2-negative participants will receive IT cDC1 vaccines plus IT nivolumab.

Primary Outcome Measure

Safety Run-In: Maximum Tolerated Dose (MTD) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Peter Forsyth, MD (PRINCIPAL_INVESTIGATOR)
Kamran Ahmed, MD (SUB_INVESTIGATOR)
Andre Beer Furlan, MD (SUB_INVESTIGATOR)
Brian Czerniecki, MD (SUB_INVESTIGATOR)
Arnold Etame, MD (SUB_INVESTIGATOR)
Joaquim Farinhas, MD (SUB_INVESTIGATOR)
Alisha Fell, ARNP (SUB_INVESTIGATOR)
Patrick Grogan, MD (SUB_INVESTIGATOR)
Hyo Han, MD (SUB_INVESTIGATOR)
Hien Liu, MD (SUB_INVESTIGATOR)
James Liu, MD (SUB_INVESTIGATOR)
Sepideh Mokhtari, MD (SUB_INVESTIGATOR)
Yolanda Pina, MD (SUB_INVESTIGATOR)
Aixa Soyano Muller, MD (SUB_INVESTIGATOR)
Nam Tran, MD (SUB_INVESTIGATOR)
Michael Vogelbaum, MD (SUB_INVESTIGATOR)
Michael Yu, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
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By specialty
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By research site
Moffitt Cancer Center· Tampa, FL

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