Locally Advanced Triple Negative Breast CancerEarly Phase 1NCT06637306
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
A Early Phase 1 study testing Dupilumab, Pembrolizumab and Paclitaxel in people with Locally Advanced Triple Negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Rima Patel at 1 site in United States.
Trial summary
Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab, paclitaxel, and carboplatin in locally advanced triple negative breast cancer (TNBC). Primary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Dupilumab, Pembrolizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 10 Mar 2027
- Phase
- Early 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
- Patients with pathologically confirmed diagnosis of triple negative breast cancer, as defined by the most recent ASCO/CAP guidelines.
- Patients must have previously untreated, localized TNBC with either tumor size ≥ 2 centimeters (T2-4N0) or lymph node involvement with at least a 1cm tumor (T1c-T4N1-3).
- Patients must have previously untreated disease with no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer.
- Patients must be eligible to receive chemotherapy agents in the study including paclitaxel and carboplatin.
- Patients must be willing and able to provide blood samples at the time points indicated in the study calendar.
- Patients must be willing and able to have core needle biopsies of tumor prior to initiation of treatment. Should patients undergo pre-treatment or on-treatment biopsy procedure and inadequate number of biopsies are obtained, they may proceed with initiation/continuation of treatment at the discretion of the investigator and treating physician.
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- Age ≥ 18 years.
- ECOG performance status 0-1.
- Adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or any treatment with therapeutic intent for the breast cancer.
- Patients may not be receiving any other investigational agents.
- Patients who have any distant metastases and considered to have Stage IV disease.
- Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
- Patients with active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, dupilumab or pembrolizumab used in study. Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps).
- HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with <350 CD4+ T cells/microliter in the peripheral blood.
- Known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
- Known, untreated helminth infections. Patients with prior history of a helminth infection who were fully treated are permitted.
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
- Receipt of a live vaccine within 30 days of planned start of study medication.
- History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy.
- History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. History of radiation pneumonitis treated with glucocorticoids.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine Vandris contact
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Health System
New York, New York, 10029
Katherine Vandris, Katherine.Vandris@mssm.edu
Rima Patel
About this study
Official title: Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab, paclitaxel, and carboplatin in locally advanced triple negative breast cancer (TNBC).
Primary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events (irAEs) in patients with locally advanced TNBC.
Secondary Objectives: To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab; to determine the rate of residual cancer burden 0-1; to estimate the recurrence-free survival and overall survival; to assess the toxicity of the combination of dupilumab, pembrolizumab, and paclitaxel-carboplatin.
- Being tested
- Dupilumab, Pembrolizumab, Paclitaxel, Carboplatin
- Keywords
- Dupilumab, Pembrolizumab, IL-4 Receptor Antagonist, Breast Cancer, Triple Negative, Locally Advanced
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called DUPIXENT
Dupilumab 600mg subcutaneous initial loading dose, 300mg for subsequent doses; administered every 3 weeks for 4 cycles. Immunotherapy drug FDA approved to treat patients with eczema, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Investigational/not yet FDA approved to treat patients with breast cancer.
PembrolizumabDrug
Also called KEYTRUDA
Pembrolizumab 200mg intravenous every 3 weeks for 4 cycles and one 400mg intravenous dose one week following completion of chemotherapy. Cancer immunotherapy drug FDA approved for the treatment of high-risk, early-stage, triple-negative breast cancer (TNBC).
PaclitaxelDrug
Also called TAXOL
Paclitaxel 80mg/m2 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer.
CarboplatinDrug
Carboplatin AUC 1.5 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Patients with locally advanced TNBC | Experimental | Patients with advanced triple negative breast cancer (TNBC). Receives: Drug: Dupilumab; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe immune-related adverse events (irSAE)
Incidence of severe immune-related adverse events within 4 months of therapy.
Immune related Severe Adverse Events (irSAE) are defined as:
- Any Grade 4 immune-related AE with the exception of hypothyroidism
- Any Grade 3 immune-related AE requiring permanent discontinuation of dupilumab and pembrolizumab
- Any new Grade 3 or Grade 4 non-hematologic laboratory abnormality, if
- medical intervention is required, or
- the abnormality leads to hospitalization, or
- the abnormality persists for > 72 hours
- Any non-hematologic AE which is considered severe or life-threatening and requires discontinuation of dupilumab and pembrolizumab
- Any ≥ Grade 2 immune-mediated uveitis
- Any immune-related AE resulting in persistent or significant disability/incapacity (substantial disruption of one's ability to conduct normal life functions) for a period of 30 days or greater
- Grade 5 or life-threatening toxicity
Measured: Within 4 months of therapy
Secondary outcomes (10)
Proportion of patients with pathologic complete response (pCR) with 95 percent Wilson Score interval
Pathologic complete response (pCR) is defined as the lack of invasive cancer in the breast and axilla at time of surgical resection after neoadjuvant therapy. The research team will calculate the proportion of patients with pathologic complete response with 95 percent Wilson Score interval without continuity correction.
Measured: During procedure, after 13 weeks of neoadjuvant therapy
Proportion of patients with residual cancer burden (RCB) categories 0 and 1 with 95 percent Wilson Score
Residual cancer burden (RCB) categories 0-1 comprise of patients who have achieved pCR (RCB 0) and have minimal tumor burden (RCB 1) after neoadjuvant therapy. The research team will calculate the proportion of patients with residual cancer burden categories 0 and 1 with 95 percent Wilson Score interval without continuity correction.
Measured: After completion of neoadjuvant therapy (13 weeks)
Proportion of patients who did not experience an invasive breast cancer recurrence (Recurrence-Free Survival (RFS))
Recurrence-free survival (RFS) is measured as the proportion of patients who did not experience an invasive breast cancer recurrence in the ipsilateral breast or regional nodes, distant organ sites, or death from any cause for the specified time period. It is defined as time from start of treatment to occurrence of an invasive breast cancer recurrence in the ipsilateral breast or regional nodes, distant organ sites, or death from any cause.
The research team will summarize using Kaplan-Meier method with 95 percent pointwise confidence intervals using complimentary log-log scale. Median RFS with 95 percent confidence interval will be calculated using Brookmeyer and Crowley method. Hazard ratios with 95 percent confidence interval will be estimated using Proportional Hazards Cox regression model.
Measured: During procedure, after 13 weeks of neoadjuvant therapy
Overall Survival (OS)
Overall survival (OS) is defined as the time from the start of treatment until documented death from any cause. The research team will summarize using Kaplan-Meier method with 95 percent pointwise confidence intervals using complimentary log-log scale. Median RFS with 95 percent confidence interval will be calculated using Brookmeyer and Crowley method. Hazard ratios with 95 percent confidence interval will be estimated using the Cox Proportional Hazards regression model.
Measured: After completion of neoadjuvant therapy (13 weeks)
Number of immune-related adverse events grades 3-5
Toxicity will be measured by the number immune-related adverse events grades 3-5 and incidence of severe TEAE (Grade 3-5 or serious AEs) according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, as well as based on rates of dose interruptions and drug discontinuations due to adverse events.
Measured: Within 3 months and 6 months of treatment
Number of adverse events measured using CTCAE Version 5.0
Number of adverse events will be reported according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Within 3 months and 6 months of treatment
Incidence of all-grade immune-related adverse events
Incidence of all-grade immune-related adverse events and severe TEAEs with the combination therapy within 3 months at the last study visit and within 6 months with chart review.
Measured: Within 3 months and 6 months of treatment
Type of adverse events
The type of severe adverse events will be collected.
Measured: Within 3 months and 6 months of treatment
Number of dose interruptions
The research team will assess the number of dose interruptions due to AEs with 95 percent Wilson Score interval without continuity correction.
Measured: Within 3 months and 6 months of treatment
Number of drug discontinuations
The research team will assess the number of drug discontinuations due to AEs with 95 percent Wilson Score interval without continuity correction.
Measured: Within 3 months and 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Mar 2025
- Primary completion10 Mar 2027 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Triple Negative 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label, Single Arm Trial.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rima Patel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rima Patel, Icahn School of Medicine at Mount Sinai
- Investigators
- Rima Patel, MD, Principal investigator, Icahn School of Medicine at Mount SinaiJoseph Sparano, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637306
- Sponsor's protocol ID
- PRMC-24-125
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06637306
- Acronym / sponsor ID
- PRMC-24-125
- Keywords
- Dupilumab, Pembrolizumab, IL-4 Receptor Antagonist, Breast Cancer, Triple Negative, Locally Advanced
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rima PatelUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 15 Oct 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.
Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab, paclitaxel, and carboplatin in locally advanced triple negative breast cancer (TNBC).
Primary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events (irAEs) in patients with locally advanced TNBC.
Secondary Objectives: To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab; to determine the rate of residual cancer burden 0-1; to estimate the recurrence-free survival and overall survival; to assess the toxicity of the combination of dupilumab, pembrolizumab, and paclitaxel-carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label, Single Arm Trial.
| Arm | Type | Receives |
|---|---|---|
| Patients with locally advanced TNBC | Experimental | Drug: Dupilumab, Drug: Pembrolizumab, Drug: Paclitaxel, Drug: CarboplatinPatients with advanced triple negative breast cancer (TNBC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with pathologically confirmed diagnosis of triple negative breast cancer, as defined by the most recent ASCO/CAP guidelines.
- Patients must have previously untreated, localized TNBC with either tumor size ≥ 2 centimeters (T2-4N0) or lymph node involvement with at least a 1cm tumor (T1c-T4N1-3).
- Patients must have previously untreated disease with no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer.
- Patients must be eligible to receive chemotherapy agents in the study including paclitaxel and carboplatin.
- Patients must be willing and able to provide blood samples at the time points indicated in the study calendar.
Key exclusion criteria (16 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or any treatment with therapeutic intent for the breast cancer.
- Patients may not be receiving any other investigational agents.
- Patients who have any distant metastases and considered to have Stage IV disease.
- Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
- Patients with active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
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 |
|---|---|---|
| DupilumabAlso: DUPIXENTDupilumab 600mg subcutaneous initial loading dose, 300mg for subsequent doses; administered every 3 weeks for 4 cycles. Immunotherapy drug FDA approved to treat patients with eczema, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Investigational/not yet FDA approved to treat patients with breast cancer. | Drug | Patients with locally advanced TNBC |
| PembrolizumabAlso: KEYTRUDAPembrolizumab 200mg intravenous every 3 weeks for 4 cycles and one 400mg intravenous dose one week following completion of chemotherapy. Cancer immunotherapy drug FDA approved for the treatment of high-risk, early-stage, triple-negative breast cancer (TNBC). | Drug | Patients with locally advanced TNBC |
| PaclitaxelAlso: TAXOLPaclitaxel 80mg/m2 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer. | Drug | Patients with locally advanced TNBC |
| CarboplatinCarboplatin AUC 1.5 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer. | Drug | Patients with locally advanced TNBC |
Primary outcome
Incidence of severe immune-related adverse events (irSAE)
Time frame: Within 4 months of therapy
Incidence of severe immune-related adverse events within 4 months of therapy. Immune related Severe Adverse Events (irSAE) are defined as: * Any Grade 4 immune-related AE with the exception of hypothyroidism * Any Grade 3 immune-related AE requiring permanent discontinuation of dupilumab and pembrolizumab * Any new Grade 3 or Grade 4 non-hematologic laboratory abnormality, if * medical intervention is required, or * the abnormality leads to hospitalization, or * the abnormality persists for > 72 hours * Any non-hematologic AE which is considered severe or life-threatening and requires discontinuation of dupilumab and pembrolizumab * Any ≥ Grade 2 immune-mediated uveitis * Any immune-related AE resulting in persistent or significant disability/incapacity (substantial disruption of one's ability to conduct normal life functions) for a period of 30 days or greater * Grade 5 or life-threatening toxicity
10 secondary outcomes
Proportion of patients with pathologic complete response (pCR) with 95 percent Wilson Score interval
Time frame: During procedure, after 13 weeks of neoadjuvant therapy
Proportion of patients with residual cancer burden (RCB) categories 0 and 1 with 95 percent Wilson Score
Time frame: After completion of neoadjuvant therapy (13 weeks)
Proportion of patients who did not experience an invasive breast cancer recurrence (Recurrence-Free Survival (RFS))
Time frame: During procedure, after 13 weeks of neoadjuvant therapy
Overall Survival (OS)
Time frame: After completion of neoadjuvant therapy (13 weeks)
Number of immune-related adverse events grades 3-5
Time frame: Within 3 months and 6 months of treatment
Number of adverse events measured using CTCAE Version 5.0
Time frame: Within 3 months and 6 months of treatment
Incidence of all-grade immune-related adverse events
Time frame: Within 3 months and 6 months of treatment
Type of adverse events
Time frame: Within 3 months and 6 months of treatment
Number of dose interruptions
Time frame: Within 3 months and 6 months of treatment
Number of drug discontinuations
Time frame: Within 3 months and 6 months of treatment
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 14 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Katherine Vandris contact
Rima Patel, MD principal investigator
Icahn School of Medicine at Mount Sinai
Joseph Sparano, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dupilumab, Pembrolizumab and Paclitaxel in people with Locally Advanced Triple Negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Rima Patel 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 19 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 14 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Rima Patel, MD ((212) 604-6010, Rima.Patel2@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe immune-related adverse events (irSAE) (time frame: Within 4 months of therapy). 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 14 May 2026.