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New treatment option for Breast Cancer
Official title Brodalumab in the Treatment of Immune-Related Adverse Events
ClinicalTrials.gov ID: NCT06673329
What this study is testing
What is Brodalumab?
Brodalumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for breast cancer.
Also referred to as SILIQ.
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 test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects.
- Phase 1: an early, usually small safety study
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
- Ability to provide written informed consent by subject or guardian
- Individuals \>18 years of age
- Diagnosis of an irAE clinically suspected to be IL-17 mediated
- Intent-to-treat or prior treatment with systemic steroids for irAE management
- Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are...
You likely can't join if
- Estimated creatinine clearance \< 40 mg/min
- Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV))...
- History of prior suicide attempts
- PHQ-9 score greater \>5 and \< 20 without an established mental health provider who verifies stability in their depression
- Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV)
- In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab)
See the full eligibility criteria
Who can join
- Ability to provide written informed consent by subject or guardian
- Individuals \>18 years of age
- Diagnosis of an irAE clinically suspected to be IL-17 mediated
- Intent-to-treat or prior treatment with systemic steroids for irAE management
- Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll.
- Subject has a negative test for tuberculosis during screening defined as either: negative purified protein derivative (PPD) (\< 5 mm of induration at 48 to 72 hours after test is placed) OR negative QuantiFERON test...
- people with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test.
- people with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or people with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of...
What rules you out
- Estimated creatinine clearance \< 40 mg/min
- Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV)) at the time of enrollment or a PHQ-9 score \> 20
- History of prior suicide attempts
- PHQ-9 score greater \>5 and \< 20 without an established mental health provider who verifies stability in their depression
- Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV)
- In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab)
- Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab
- Prior treatment with brodalumab
- Pregnancy, breastfeeding, or use of a nonreliable method of contraception
- For patients assigned female at birth: lack of willingness to use highly effective methods of birth control during treatment and for at least 4 weeks after the last dose of brodalumab (except if surgically sterile or at...
- Highly effective methods of birth control include: use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Oral contraceptive pills must be...
- Patients planning to become pregnant while enrolled in the study and within 4 weeks after the last dose of brodalumab will not be permitted to enroll
- Chronic or current severe infection requiring IV therapy
- Evidence of active hepatitis B, C, or tuberculosis.
- History of latent tuberculosis infection which is incompletely treated based upon local standard of care or which was never treated
- History of or active Crohn's disease.
- Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose
- Any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
- Any medical condition or treatment for a condition that, in the opinion of the investigator, might interfere with participation in the study or affect the reliability of clinician assessment or patient self-report
- Other known clinically significant active medical conditions, such as:
- Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D)
- Aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal or greater than 3 times the upper limit of normal in patients with liver metastases measured on at...
- Direct bilirubin greater than or equal to 1.5 mg/dL in patients with or without liver metastases
- Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with White Blood Cell (WBC) \<2000/mm3, absolute neutrophil count \<1500/ mm3, thrombocytopenia (platelet count) \<50,000/mm3...
- Plan to proceed with further curative intent treatment for cancer at the time of enrollment despite the presence of irAE
- Participation in another therapeutic clinical trial and receipt of investigational drugs within 4 weeks before the screening visit
- Previous diagnosis of an autoimmune disease or administration of immunosuppressants in a time frame that would impede interpretation of brodalumab administration
- Planned use of immunosuppressive agents other than steroids (including infliximab, vedolizumab, tocilizumab etc.) or administration of such agents within 28 days of trial initiation
- Administration of live-virus vaccines within 4 weeks before the first dose of brodalumab
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 New York, New York, 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.