BridgeMD
New treatment option for Breast Cancer
Official title Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD
ClinicalTrials.gov ID: NCT07694986
What this study is testing
What is cDC1 Vaccine?
cDC1 Vaccine is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Dendritic Cell Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Coincident brain or spinal cord metastases are allowed if these are stable and do not require local therapy at the time of enrollment. Individuals...
You likely can't join if
- 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...
- Contraception: Highly effective contraception for both male and female people throughout the study, and for the following specified durations after...
- 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. Exclusion Criteria:
- Receiving other treatments specifically administered to treat LMD within the last 2 weeks or 5 half-lives of the agent, whichever is less. However...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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 (
What rules you out
- 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 people throughout the study, and for the following specified durations after the last treatment administration as follows: highly effective...
- 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. Exclusion Criteria:
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.