BridgeMD
New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05098210
What this study is testing
What is Neoantigen Peptide Vaccine?
Neoantigen Peptide Vaccine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for anatomic stage iv breast cancer ajcc v8.
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
- This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment (refractory) or stage III-IV non-small cell lung cancer. Personalized neo-antigen peptide vaccine is a product that combines multiple patient specific neo-antigens.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
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
- Female and/or male patients age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Patients must have at least 1 lesion (or aggregate lesions) to obtain tumor tissue for resection of \>= 1 cm or \>= 4 core biopsies acceptable...
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria: Participants must have measurable disease, defined as at...
- Serum creatine \ 60 mL/min
You likely can't join if
- Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as...
- Any history of an immune-related grade 4 adverse event attributed to prior cancer immunotherapy CIT (other than endocrinopathy managed with...
- Any history of an immune-related grade 3 adverse event attributed to prior CIT that required permanent discontinuation of PD-1 inhibitor therapy
- Immune-related adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not...
- Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage...
See the full eligibility criteria
Who can join
- Female and/or male patients age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Patients must have at least 1 lesion (or aggregate lesions) to obtain tumor tissue for resection of \>= 1 cm or \>= 4 core biopsies acceptable. Amenable to image (CT, ultrasound [U/S], or magnetic resonance imaging...
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension...
- Serum creatine \ 60 mL/min
- Total bilirubin (tBili) \ 3 but no other evidence of hepatic dysfunction
- =\ = 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, patients with forced expiratory volume in 1 second (FEVI) \>= 70% of predicted and...
- Patients with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids will be excluded
- Patients 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and...
- people with a history of myocarditis or congestive heart failure (as defined by New York Heart Association functional classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia...
- Absolute neutrophil count (ANC) \> 1000 cells/mm\^3
- Hemoglobin \>= 9 mg/dL
- Platelet count \>= 50,000/uL
- Toxicity from prior therapy must be recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5 grade 2 or less
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
- Capable of understanding and providing a written informed consent
- The effects of neoantigen vaccination on the developing human fetus are unknown. For this reason, patients who are having sex that can lead to pregnancy must agree to use adequate contraception (hormonal, barrier method...
- MELANOMA SPECIFIC: Tissue confirmation of melanoma: Histologically confirmed metastatic (recurrent or de novo stage IV) or unresectable locally advanced (stage IIIC or IIID) cutaneous, acral, conjunctival or mucosal...
- MELANOMA SPECIFIC: Patients must have received stage specific standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines and have persistent/recurrent disease after at least one line of therapy...
- MELANOMA SPECIFIC: Known BRAF mutational status
- MELANOMA SPECIFIC: History of detectable disease during/after treatment with a PD-1 or PD-L1 inhibitor, as defined by the Society of Immunotherapy of Cancer's definition of primary or secondary resistance (Kluger and...
- Drug exposure \>= 6 weeks and best response progressive disease (PD) or stable disease (SD) \< 6 months or
- Drug exposure \>= 6 months and best response complete response (CR), partial response (PR), or SD \> 6 months
- MELANOMA SPECIFIC: A confirmatory scan performed at least 4 weeks after disease persistence/progression is required but this requirement can be waived if the judgement of the treating clinician is that the patient would...
- BREAST CANCER SPECIFIC: Tissue confirmation of stage IV (recurrent or de novo metastatic) hormone receptor (HR) positive, HER2 negative breast cancer:
- Hormone receptor (HR) positive breast cancer as defined by either one, or both of the following criteria:
- Estrogen receptor (ER) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy
- Progesterone receptor (PR) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy
- Human epidermal growth factor receptor 2 (HER2) negative breast cancer (per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guideline update, 2018) as documented by a local laboratory...
- Immunohistochemistry score 0/1+ or 2+ and / or
- Negative by in situ hybridization (fluorescence in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver-enhanced in situ hybridization [SISH]) per ASCO/CAP guideline update, 2018
- Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC/UWMC
- BREAST CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic setting prior to enrollment on the study and have progressive/persistent disease after
- NON-SMALL CELL LUNG CANCER SPECIFIC: Tissue confirmation of stage III unresectable or stage IV (recurrent or de novo metastatic) non-small cell lung cancer (NSCLC):
- Genetic testing must have been performed for targetable driver mutations, including EGFR, ROS1, Alk, KRAS, BRAF
- Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC/UWMC
- NON-SMALL CELL LUNG CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic or stage II or III setting including a PD-1 or PD-L1 inhibitor prior to enrollment on the study...
- NON-SMALL CELL LUNG CANCER SPECIFIC: For patients who have received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 for stage II or III disease, they must have experienced disease progression in less...
What rules you out
- Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at...
- Any history of an immune-related grade 4 adverse event attributed to prior cancer immunotherapy CIT (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase)
- Any history of an immune-related grade 3 adverse event attributed to prior CIT that required permanent discontinuation of PD-1 inhibitor therapy
- Immune-related adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not resolved to baseline. Patients treated with corticosteroids for...
- Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®) are allowed
- Patients with known symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or...
- Patients with rapidly progressing disease, symptomatic visceral disease, or patients who are expected to have rapidly progressive disease over the course of several months despite bridging therapy approved by the...
- Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott-Aldrich...
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- Known positive test for HIV infection
- Patients with active infection causing fever (temperature \> 38.1 degrees Celsius [C]) or people with unexplained fever (temperature \> 38.1 degrees C) may not receive the investigational product unless the fever is =\<...
- Active uncontrolled infection: individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have, per standard practice...
- History of autoimmune disease that has not been controlled with treatment in the last 12 months, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular...
- Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone \> 10 mg/day or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and TNF-alpha antagonists) within 2...
- people should have an international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless the subject is receiving anticoagulant therapy. people on anticoagulant therapy should have...
- Other medical, social, or psychiatric factor that interferes with medical appropriateness and/or ability to comply with study, as determined by the principal investigator (PI)
- Participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. Childbearing potential is defined as women who have not been surgically sterilized and who are not...
- Female patients who are lactating or intend to breastfeed during the duration of the study
- Patients who have received a live vaccine within 30 days prior to enrollment
- Patients with any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant (e.g.- compromises the health of the subject) or that could...
- MELANOMA SPECIFIC: Uveal or choroidal melanoma. This entity is excluded due to the absence of abundant mutations
- BREAST SPECIFIC: Patients with symptomatic disease including patients with symptomatic lung metastases, bone marrow replacement with associated cytopenia, or significant liver metastases with associated liver dysfunction
- NON-SMALL CELL LUNG CANCER SPECIFIC: Activating mutations in EGFR or genetic alterations in ROS1 or Alk, as these mutations are associated with lower mutation burden and non-response to immune therapies
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, 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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Seattle, Washington, 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.