AzTrials
AzTrials

Breast CancerPhase 2NCT07694986

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

A Phase 2 study testing cDC1 Vaccine, Trastuzumab and Nivolumab in people with Breast Cancer and Leptomeningeal Disease, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Leptomeningeal Disease
What is being tested?
cDC1 Vaccine, Trastuzumab and Nivolumab
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2026to Aug 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of BC by ASCO/CAP guidelines (Wolff et al, 2018), or radiographically definite LMD from BC.
  • Trial participants must have a diagnosis of LMD. They must have the presence of malignant cells in the CSF (CSF+; note now cytology is considered diagnostic of LMD if the cytology is read as positive or suspicious; [Chamberlain et al., 2017] OR characteristic radiographic abnormalities of LMD). Signs and symptoms of LMD in and of themselves are not sufficient for inclusion.
  • Patients must have an ECOG performance scale of ≤2.
  • Proton cranial spinal RT OR cranial spinal RT using IMRT are the preferred modalities of RT to treat LMD if possible, before study. At least WBRT is required for participation.
  • Coincident brain or spinal cord metastases are allowed if these are stable and do not require local therapy at the time of enrollment. Individuals with previously treated stable brain metastases are eligible to participate.
  • Stereotactic radiosurgery (SRS) and/or prior radiotherapy is permitted ≥2 weeks before the initial dendritic cell (DC) vaccine dose. A follow-up brain MRI should be obtained before the DC vaccine to determine the stability of the lesions. An interval of at least 2 weeks after the end of brain radiation or surgical resection of brain lesions or cytotoxic, targeted, immune, or investigational agent is required.
Show all 17Show fewer
  • Must be ≥18 years of age on the day of signing the consent.
  • Life expectancy of ≥8 weeks.
  • Demonstrate adequate organ function as defined in Table 5. All screening labs should be performed within 14 days of treatment initiation.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Corticosteroids at doses equivalent to ≤4 mg of dexamethasone daily or equivalent for symptom control are acceptable. This should be minimized when possible.
  • If the disease has progressed on current treatment before consent, patients may continue current systemic cancer therapies by PI discretion see Section 7.7.5 (Systemic Therapies Allowed) and Section 5.2, 1 and 2 (Exclusion Criteria).
  • Patients with systemic disease are eligible and will be managed as detailed in Section 7.7.5.
  • Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential. Must be repeated once a month during treatment.
  • Contraception: Highly effective contraception for both male and female subjects throughout the study, and for the following specified durations after the last treatment administration as follows: highly effective contraception must be used by males for at least 90 days after the last treatment administration, if the risk of conception exists, to cover the spermatogenesis Cycle, and at least 5 months after the last dose of nivolumab or 7 months after the last dose of trastuzumab for females.
  • The patient has an Ommaya reservoir or equivalent device that allows routine access to CSF and administration of DC1s.
  • Patient must be able to tolerate MRIs of brain with contrast for routine disease assessments.

Who cannot join

  • Receiving other treatments specifically administered to treat LMD within the last 2 weeks or 5 half-lives of the agent, whichever is less. However, all other treatments to control systemic disease or bulk CNS disease will be eligible, provided the therapy is not a Phase I agent, an agent that significantly and unequivocally penetrates the CSF (eg, high-dose methotrexate, thiotepa, high-dose ara-C) by PI discretion. H \& P section: Patients may continue on IV trastuzumab, fam-trastuzumab deruxtecan-nxki, pertuzumab, tucatinib, or other HER2-directed, hormonal, or other therapeutic agents if controlling systemic disease and leptomeningeal metastases developed while on these therapies. In addition, at time of systemic progression, patients may start additional agents at the discretion of the treating physician according to criteria in Section 6.7.1. and not start on new systemic therapies until LMD disease assessment.
  • Use of any immunotherapy within the last 4 weeks.
  • Unable or unwilling to have a contrast-enhanced brain MRI.
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has an active infection requiring systemic therapy which in the investigator's opinion will increase the risk to the patient.
  • Had major surgical procedure, or significant traumatic injury within 2 weeks. Ommaya placement is allowed.
Show all 16Show fewer
  • Patients with shunts are excluded from the study (including but not limited to ventriculoperitoneal and ventriculoatrial shunts).
  • History of an intracranial thrombosis or thrombi extending up to the skull base. The choice of modality is at the investigator or provider's discretion.
  • Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1, 2 antibodies). Testing is not mandatory.
  • Has known active or chronic hepatitis B (HBV) or hepatitis C virus (HCV). Testing is not mandatory.
  • ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation.
  • Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Has received a live vaccine within 30 days before the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed. Current COVID vaccines are not live vaccines.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julianne Hardesty contact

813-745-4098

Julianne.Hardesty@moffitt.org

United States1 site, 1 recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Peter Forsyth, MD

    Kamran Ahmed, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Trial With a Safety Run-in of Combinatorial Therapies With Intrathecal (IT) Dendritic Cell Vaccines (cDC1s) inHER+ (Combined With IT Trastuzumab) and HER2- (Combined With IT Nivolumab) Breast Cancer (BC) Leptomeningeal Disease (LMD)

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).

Being tested
cDC1 Vaccine, Trastuzumab, Nivolumab
Medical subject headings
Breast Neoplasms, Meningeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cDC1 VaccineBiological

    Also called Dendritic Cell Vaccine

    Autologous peptide-pulsed cDC1 vaccine administered intrathecally.

  • TrastuzumabDrug

    150 mg intrathecal weekly for HER2-positive participants.

  • NivolumabDrug

    50 mg intrathecal every 2 weeks for HER2-negative participants.

Study groups in NCT07694986
Study groupRoleWhat they receive
Safety Run-In HER2- CohortExperimentalParticipants with HER2-negative breast cancer leptomeningeal disease (TNBC or HR-positive) receive intrathecal HER3-pulsed cDC1 vaccines in combination with IT nivolumab.
Receives: Biological: cDC1 Vaccine; Drug: Nivolumab
Safety Run-In HER2+ CohortExperimentalParticipants with HER2-positive breast cancer leptomeningeal disease receive intrathecal (IT) HER2/HER3 peptide-pulsed cDC1 vaccines in combination with IT trastuzumab.
Receives: Biological: cDC1 Vaccine; Drug: Trastuzumab
Phase 2 Efficacy CohortExperimentalFollowing 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.
Receives: Biological: cDC1 Vaccine; Drug: Trastuzumab; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Run-In: Maximum Tolerated Dose (MTD)

    MTD of IT cDC1s combined with IT trastuzumab for HER2+ patients or with IT nivolumab for HER2- patients.

    Measured: Up to 28 days

  2. Phase 2: Median Overall Survival

    Median survival from initiation of study treatment.

    Measured: Up to 1 year

  3. Phase 2: One-Year Survival Rate

    Proportion of participants alive at one year after treatment initiation.

    Measured: Up to 1 year

Secondary outcomes (2)

  1. Progression Free Survival (PFS)

    Progression-free survival is defined as the time from first study treatment (Cycle 1 Day 1) until documented disease progression or death from any cause, whichever occurs first.

    Measured: Up to 1 year

  2. Objective Response Rate (ORR)

    The proportion of participants achieving an objective response during study treatment. Response in leptomeningeal/CNS disease will be assessed using Response Assessment in Neuro-Oncology Leptomeningeal Metastases (RANO-LM) criteria, and response in non-CNS/systemic disease will be assessed using RECIST version 1.1 criteria.

    Measured: Up to 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07694986
Sponsor's protocol ID
MCC-23481
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cDC1 Vaccine, Trastuzumab and Nivolumab in people with Breast Cancer and Leptomeningeal Disease, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julianne Hardesty (813-745-4098, Julianne.Hardesty@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Run-In: Maximum Tolerated Dose (MTD) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07694986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in