Breast CancerPhase 1NCT06673329
Brodalumab in the Treatment of Immune-Related Adverse Events
A Phase 1 study testing Brodalumab and CT scan in people with Breast Cancer and Esophageal Cancer, run by Brian Henick, MD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Esophageal Cancer, Kidney Cancer
- What is being tested?
- Brodalumab and CT scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to Nov 2027
- Phase
- Phase 1
- 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
- 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. Tuberculosis testing must be performed within 30 days prior to trial initiation.
- Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test.
- Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of tuberculosis (defined as fever, shortness of breath, cough or night sweats), documented history of a completed course of adequate prophylaxis (per local standard of care), no known exposure to a case of active tuberculosis after most recent prophylaxis, no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of brodalumab.
Who cannot join
- 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)
Show all 29Show fewer
- 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 least 2 years postmenopausal, with postmenopausal status confirmed by Follicle-Stimulating Hormone (FSH) in the postmenopausal range).
- 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 supplemented by a barrier method.
- 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 least two separate occasions
- 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, hemoglobin < 8.0 g/dL
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Brian Henick, MD, 212-305-5098, bh2682@cumc.columbia.edu
About this study
Official title: Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study
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. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.
Read the detailed description
The proposed study will evaluate the safety and efficacy of brodalumab in improving and resolving Immune-Related Adverse Events (irAEs) in patients treated with brodalumab. Eligible subjects must have an immune-related adverse event with the intent to treat it with steroids. Subjects will receive subcutaneous brodalumab for 24 weeks. Peripheral blood will be collected at all in-person study visits for mechanistic studies. Participants will be evaluated at week 0, 1, 2, 4, and then every 4 weeks after that until week 24 as dictated by the standard of care using a combination of telemedicine and face-to-face evaluations. Additional safety follow-up visits will occur at weeks 28 and 36. All patients will have the Columbia Suicide Severity Rating Scale (C-SSRS), and Patient Health Questionnaire-9 (PHQ-9) administered at all visits. The treatment protocol consists of subcutaneous brodalumab 210 mg administered at baseline and then at weeks 0, 1, and 2, then bi-weekly for a total of 24 weeks (the current FDA-approved dosing for plaque psoriasis). Glucocorticoids may be used at baseline at the discretion of the investigators, with the goal of tapering off of steroids over 4-8 weeks if tolerated (see proposed taper in appendix). Continued treatment beyond the 24-week course can be evaluated by the treating investigator and the Sponsor-Investigator, weighing risks versus clinical benefit.
- Conditions
- Breast Cancer, Esophageal Cancer, Kidney Cancer, Lung Cancer, Thyroid Cancer, Gynecologic Cancer
- Being tested
- Brodalumab, CT scan
- Medical subject headings
- Breast Neoplasms, Esophageal Neoplasms, Kidney Neoplasms, Lung Neoplasms, Thyroid Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabDrug
Also called SILIQ
Brodalumab 210 mg subcutaneous injection
CT scanRadiation
CT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment
| Study group | Role | What they receive |
|---|---|---|
| brodalumab to treat irAEs in patient with solid tumors | Experimental | Brodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24 Receives: Drug: Brodalumab; Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
The number of adverse events of each grade that occur and the number of adverse events attributed to brodalumab, as per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5).
Measured: Up to 36 weeks
Percentage of primary Immune-Related Adverse Event (irAE) severity decreased
The percentage of patients whose primary irAE severity decreased by >1 grade per CTCAE criteria from study completion to treatment discontinuation.
Measured: 24 weeks
Secondary outcomes (9)
Percentage net decrease in the average steroid dose required for irAE management
The percentage of patients with a net decrease in the average steroid dose required for irAE management (defined by the ratio of the average steroid dose in prednisone equivalents over the 7 days following enrollment compared to the average dose in the 7 days prior to study completion).
Measured: Up to 36 weeks
Proportion of Patients Successfully Tapered Off Steroids
The proportion of patients who can be tapered completely off of steroids (and remain off for a minimum of 1 week).
Measured: Up to 36 weeks
Mean Time to Complete Resolution of irAE Symptoms
Mean time to complete resolution of irAE clinical manifestation ((as defined as absence of signs/symptoms consistent with the irAE or return to baseline symptoms prior to irAE development)).
Measured: Up to 36 weeks
Change in Tumor Burden Assessed by RECIST Criteria at 24 Weeks
Change in tumor burden as measured by RECIST criteria comparing CT/MRI scan at the time of enrollment to CT/MRI scan at 24 weeks.
Measured: 24 weeks
Proportion of Patients with Grade 3 or Higher Infection Events
The proportion of patients with > grade 3 infection per CTCAE.
Measured: Up to 36 weeks
Cumulative Steroid Exposure over 24 Weeks
Cumulative steroid exposure (in prednisone equivalents) over 24 weeks
Measured: 24 weeks
FACT-G global assessment score
Change in the quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G) global assessment score. Score range is 0-108. Higher scores indicate a better quality of life, while lower scores suggest worse outcomes.
Measured: Baseline and 24 weeks
Progression-free survival (PFS)
PFS is defined as the duration of time from the start of treatment to the time of progression or death, whichever occurs first, measured in months
Measured: Up to 36 weeks
Overall Survival (OS)
OS is defined as the duration of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive, measured in months.
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start11 Mar 2025
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Henick, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor-investigator, Brian Henick, MD, Columbia University
- Investigators
- Brian Henick, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673329
- Sponsor's protocol ID
- AAAV1382
- Status last verified
- May 2026
- First submitted
- 31 Oct 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study
- ClinicalTrials.gov ID
- NCT06673329
- Acronym / sponsor ID
- AAAV1382
- Conditions
- Breast Cancer, Esophageal Cancer, Kidney Cancer, Lung Cancer, Thyroid Cancer, Gynecologic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Brian Henick, MDUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.
Detailed description
The proposed study will evaluate the safety and efficacy of brodalumab in improving and resolving Immune-Related Adverse Events (irAEs) in patients treated with brodalumab. Eligible subjects must have an immune-related adverse event with the intent to treat it with steroids. Subjects will receive subcutaneous brodalumab for 24 weeks. Peripheral blood will be collected at all in-person study visits for mechanistic studies. Participants will be evaluated at week 0, 1, 2, 4, and then every 4 weeks after that until week 24 as dictated by the standard of care using a combination of telemedicine and face-to-face evaluations. Additional safety follow-up visits will occur at weeks 28 and 36. All patients will have the Columbia Suicide Severity Rating Scale (C-SSRS), and Patient Health Questionnaire-9 (PHQ-9) administered at all visits. The treatment protocol consists of subcutaneous brodalumab 210 mg administered at baseline and then at weeks 0, 1, and 2, then bi-weekly for a total of 24 weeks (the current FDA-approved dosing for plaque psoriasis). Glucocorticoids may be used at baseline at the discretion of the investigators, with the goal of tapering off of steroids over 4-8 weeks if tolerated (see proposed taper in appendix). Continued treatment beyond the 24-week course can be evaluated by the treating investigator and the Sponsor-Investigator, weighing risks versus clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brodalumab to treat irAEs in patient with solid tumors | Experimental | Drug: Brodalumab, Radiation: CT scanBrodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrodalumabAlso: SILIQBrodalumab 210 mg subcutaneous injection | Drug | brodalumab to treat irAEs in patient with solid tumors |
| CT scanCT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment | Radiation | brodalumab to treat irAEs in patient with solid tumors |
Primary outcome
Number of Adverse Events
Time frame: Up to 36 weeks
The number of adverse events of each grade that occur and the number of adverse events attributed to brodalumab, as per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5).
Percentage of primary Immune-Related Adverse Event (irAE) severity decreased
Time frame: 24 weeks
The percentage of patients whose primary irAE severity decreased by >1 grade per CTCAE criteria from study completion to treatment discontinuation.
9 secondary outcomes
Percentage net decrease in the average steroid dose required for irAE management
Time frame: Up to 36 weeks
Proportion of Patients Successfully Tapered Off Steroids
Time frame: Up to 36 weeks
Mean Time to Complete Resolution of irAE Symptoms
Time frame: Up to 36 weeks
Change in Tumor Burden Assessed by RECIST Criteria at 24 Weeks
Time frame: 24 weeks
Proportion of Patients with Grade 3 or Higher Infection Events
Time frame: Up to 36 weeks
Cumulative Steroid Exposure over 24 Weeks
Time frame: 24 weeks
FACT-G global assessment score
Time frame: Baseline and 24 weeks
Progression-free survival (PFS)
Time frame: Up to 36 weeks
Overall Survival (OS)
Time frame: Up to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Description Herbert Irving Comprehensive Cancer Center (HICCC) Clinical Trials pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Henick, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brodalumab and CT scan in people with Breast Cancer and Esophageal Cancer, run by Brian Henick, MD 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 8 inclusion and 29 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 13 May 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Research Nurse Navigator (212-342-5162, cancerclinicaltrials@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: Up to 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.