Anaplastic Thyroid CarcinomaPhase 2NCT07886905
Pulsed Stereotactic Ablative Radiotherapy (PULSAR) With Systematic Therapy for Thyroid Cancer
A Phase 2 study testing Dabrafenib, Trametinib and Pembrolizumab in people with Anaplastic Thyroid Carcinoma and Thyroid Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is a single institution non-randomized phase 2 trial looking at the effect of Pulsed Stereotactic Ablative Radiotherapy (PULSAR) followed by neoadjuvant chemotherapy dabrafenib and trametinib (DT) with or without pembrolizumab on patients with advanced anaplastic thyroid carcinoma (ATC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Thyroid Carcinoma, Thyroid Cancer, Thyroid Carcinoma
- What is being tested?
- Dabrafenib, Trametinib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 13 May 2029
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed anaplastic thyroid cancer, AJCC 8th Edition Stage IVB-C.
- Disease must be deemed unresectable, or resectable only with unacceptable functional morbidity (e.g., requiring total laryngectomy, total pharyngectomy, or extensive aerodigestive resection), as determined by multidisciplinary tumor board consensus.
- BRAF-V600E positive by IHC.
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
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- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.5 K/cumm
- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine clearance > 30 mL/min by Cockcroft-Gault
- Ability to swallow pills or have percutaneous enteric access (G-tube or J-tube) allowing for administration of dabrafenib-trametinib pills.
- Dabrafenib and trametinib are known teratogenic agents, and dabrafenib can render hormonal contraceptives ineffective. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 2 weeks after the last dose of dabrafenib or 4 months after the last dose of trametinib, whichever dose is later. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform the treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- Prior radiation therapy to the head and neck or spinal cord.
- Prior systemic therapy for thyroid cancer.
- Prior immunotherapy for any indication.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
- Patients with endoluminal (intraluminal/transmural) invasion of the trachea or esophagus by the primary tumor, as determined by cross-sectional imaging or endoscopy, are excluded. Tumor abutment of, or radiographic contact with, the tracheal or esophageal wall without endoluminal extension does not, by itself, meet this exclusion.
- Currently receiving any other investigational agents.
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- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib, trametinib, pembrolizumab, or other agents used in the study.
- Use of any strong inhibitors of CYP3A4 or CYP2C8, or sensitive substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2B6, within 7 days prior to enrollment and during the course of this study.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
- Active autoimmune disease that has required systemic treatment in past 2 years (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) is not considered a form of systemic treatment.
- Prior allogeneic tissue/solid organ transplant.
- Use of any immunosuppressive medications within 7 days prior to enrollment.
- Use of live or live attenuated vaccines within 30 days prior to enrollment.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 5 days prior to enrollment.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
- Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
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
Washington University School of Medicine
St Louis, Missouri, 63110
Nikhil Rammohan, MD, PhD, 314-565-5941, nikhilr@wustl.edu
Nikhil Rammohan, MD, PhD
About this study
Official title: Pulsed Stereotactic Ablative Radiotherapy (PULSAR) Combined With Targeted Systemic Therapy for Locally Advanced BRAF-V600E+ Anaplastic Thyroid Cancer
This study is a single institution non-randomized phase 2 trial looking at the effect of Pulsed Stereotactic Ablative Radiotherapy (PULSAR) followed by neoadjuvant chemotherapy dabrafenib and trametinib (DT) with or without pembrolizumab on patients with advanced anaplastic thyroid carcinoma (ATC). Pembrolizumab will be administered per standard of care (SOC) only to patients who are PDL1 positive at screening.
- Being tested
- Dabrafenib, Trametinib, Pembrolizumab, Pulsed Stereotactic Ablative Radiotherapy, Ethos
- Keywords
- Radiation Therapy, PULSAR, SBRT, Anaplastic Thyroid Carcinoma, BRAF
- Medical subject headings
- Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Also called Tafinlar
Dabrafenib is administered as a 150 mg pill that is taken twice daily, 12 hours a part. Dabrafenib is taken as part of a 3 week cycle.
TrametinibDrug
Also called Mekinist
Trametinib is administered as a 2mg pill taken once daily. Trametinib is taken as a part of a 3-week cycle.
PembrolizumabBiological
Also called Keytruda
Pembrolizumab is administered intravenously per standard of care on the Day 1 of a 3 week cycle.
Pulsed Stereotactic Ablative RadiotherapyRadiation
Also called PULSAR
PULSAR is a radiation treatment (10Gy x 1 fraction) administered up to 3 times in the neoadjuvant setting.
EthosDevice
Ethos is a unique ring-gantry CT-guided linear accelerator notable for having a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PULSAR + DT +/- Pembrolizumab | Experimental | All patients will receive 2 pulses of PULSAR spaced 2 weeks apart, followed by restaging scans. Those determined to be resectable will undergo surgery followed by maintenance dabrafenib + trametinib (DT) +/- pembrolizumab (if applicable). Those who have a partial response or stable disease will then undergo a 3rd pulse of PULSAR, followed by two cycles of DT +/- pembrolizumab. Patients will again undergo restaging scans and if they are determined to be resectable, they may undergo one bridging cycle of DT +/- pembrolizumab if possible prior to surgery. After undergoing surgery, patients will undergo maintenance DT +/- pembrolizumab. If they are still unresectable, they will start on palliative DT +/- pembrolizumab. If patients experience disease progression at any of the restaging scans, patients may receive salvage DT +/- pembrolizumab on study or discontinue treatment. Receives: Drug: Dabrafenib; Drug: Trametinib; Biological: Pembrolizumab; Radiation: Pulsed Stereotactic Ablative Radiotherapy; Device: Ethos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of 30-day mortality
Defined as death considered possibly, probably, or definitely related to PULSAR-DT +/- pembrolizumab occurring within 30 days after any administered PULSAR fraction. The treatment-related mortality rate will be calculated as the number of participants experiencing a qualifying death divided by the total number of participants in the Safety Analysis Set (all enrolled participants who receive at least one fraction or dose of any treatment, including PULSAR, dabrafenib, trametinib, or pembrolizumab) and will be presented with an exact binomial 95% confidence interval (CI).
Measured: Within 30 days after any administered PULSAR fraction (up to approximately 9 weeks)
Objective response rate (ORR) at 1st restaging
ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as assessed by RECIST 1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: At 1st restaging (estimated to be 4 weeks)
Objective response rate (ORR) at 2nd restaging
ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as assessed by RECIST 1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: At 2nd restaging (estimated to be 13-14 weeks)
Secondary outcomes (4)
Feasibility as measured by the total percentage of participants who are able to undergo surgical resection following completion of neoadjuvant PULSAR-DT +/- pembrolizumab
Feasibility rate will be calculated as the number of participants who undergo surgical resection divided by the total number of participants in the Feasibility Analysis Set. The rate will be presented with an exact binomial 95% CI.
Measured: Baseline until completion of surgery (total estimated time 5-19 weeks)
Pill compliance - dabrafenib
Dabrafenib pill compliance will be evaluated among participants who receive at least one dose of dabrafenib. For each participant and each agent, pill compliance will be calculated as the number of prescribed doses actually taken divided by the total number of doses prescribed and expressed as a percentage.
Compliance will be calculated for dabrafenib based on pill diaries and returned pill counts.
Measured: Start of dabrafenib treatment to completion of treatment (total estimated time 9 weeks)
Pill compliance - trametinib
Trametinib pill compliance will be evaluated among participants who receive at least one dose of trametinib. For each participant and each agent, pill compliance will be calculated as the number of prescribed doses actually taken divided by the total number of doses prescribed and expressed as a percentage. Compliance will be calculated for trametinib based on pill diaries and returned pill counts.
Measured: Start of trametinib treatment to completion of treatment (total estimated time 9 weeks)
Number of planned PULSAR pulses completed by participants
The number of PULSAR fractions completed will be evaluated among participants who receive at least one PULSAR fraction. The number of completed fractions will be summarized. The proportion of participants who complete all planned PULSAR fractions will also be presented with an exact binomial 95% CI.
Measured: At completion of PULSAR (estimated to be 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start31 Dec 2026 (estimated)
- Primary completion8 Apr 2029 (estimated)
- Study completion13 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Thyroid Cancer Survivors' Association
- Responsible party
- Sponsor
- Investigators
- Nikhil Rammohan, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886905
- Sponsor's protocol ID
- 26-x356
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in any publication or presentation arising from this study may be made available to qualified external researchers. All requests for data sharing are subject to prior review \& written approval by the study Principal Investigator (PI) before any data are released. No individual participant data will be shared without advance consultation with, \& documented authorization from, the PI. Data will be shared only for scientifically sound proposals that are consistent with the consent provided by study participants, that do not overlap with analyses planned or ongoing by the study team, \& that comply with all applicable institutional, IRB, privacy (e.g., HIPAA), \& data-use requirements. All released datasets will be de-identified in accordance with applicable regulations, \& a data-use agreement (DUA) executed between the requesting institution \& the sponsoring institution will be required prior to transfer.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Stereotactic Ablative Radiotherapy (PULSAR) Combined With Targeted Systemic Therapy for Locally Advanced BRAF-V600E+ Anaplastic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT07886905
- Acronym / sponsor ID
- 26-x356
- Keywords
- Radiation Therapy, PULSAR, SBRT, Anaplastic Thyroid Carcinoma, BRAF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Thyroid Cancer Survivors' Association
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 8 Apr 2029 (estimated)
- Study completion
- 13 May 2029 (estimated)
- First posted
- 21 Oct 2026 (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.
This study is a single institution non-randomized phase 2 trial looking at the effect of Pulsed Stereotactic Ablative Radiotherapy (PULSAR) followed by neoadjuvant chemotherapy dabrafenib and trametinib (DT) with or without pembrolizumab on patients with advanced anaplastic thyroid carcinoma (ATC). Pembrolizumab will be administered per standard of care (SOC) only to patients who are PDL1 positive at screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PULSAR + DT +/- Pembrolizumab | Experimental | Drug: Dabrafenib, Drug: Trametinib, Biological: Pembrolizumab, Radiation: Pulsed Stereotactic Ablative Radiotherapy, Device: EthosAll patients will receive 2 pulses of PULSAR spaced 2 weeks apart, followed by restaging scans. Those determined to be resectable will undergo surgery followed by maintenance dabrafenib + trametinib (DT) +/- pembrolizumab (if applicable). Those who have a partial response or stable disease will then undergo a 3rd pulse of PULSAR, followed by two cycles of DT +/- pembrolizumab. Patients will again undergo restaging scans and if they are determined to be resectable, they may undergo one bridging cycle of DT +/- pembrolizumab if possible prior to surgery. After undergoing surgery, patients will undergo maintenance DT +/- pembrolizumab. If they are still unresectable, they will start on palliative DT +/- pembrolizumab. If patients experience disease progression at any of the restaging scans, patients may receive salvage DT +/- pembrolizumab on study or discontinue treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed anaplastic thyroid cancer, AJCC 8th Edition Stage IVB-C.
- Disease must be deemed unresectable, or resectable only with unacceptable functional morbidity (e.g., requiring total laryngectomy, total pharyngectomy, or extensive aerodigestive resection), as determined by multidisciplinary tumor board consensus.
- BRAF-V600E positive by IHC.
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
Key exclusion criteria (17 listed)
- Prior radiation therapy to the head and neck or spinal cord.
- Prior systemic therapy for thyroid cancer.
- Prior immunotherapy for any indication.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
- Patients with endoluminal (intraluminal/transmural) invasion of the trachea or esophagus by the primary tumor, as determined by cross-sectional imaging or endoscopy, are excluded. Tumor abutment of, or radiographic contact with, the tracheal or esophageal wall without endoluminal extension does not, by itself, meet this exclusion.
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 |
|---|---|---|
| DabrafenibAlso: TafinlarDabrafenib is administered as a 150 mg pill that is taken twice daily, 12 hours a part. Dabrafenib is taken as part of a 3 week cycle. | Drug | PULSAR + DT +/- Pembrolizumab |
| TrametinibAlso: MekinistTrametinib is administered as a 2mg pill taken once daily. Trametinib is taken as a part of a 3-week cycle. | Drug | PULSAR + DT +/- Pembrolizumab |
| PembrolizumabAlso: KeytrudaPembrolizumab is administered intravenously per standard of care on the Day 1 of a 3 week cycle. | Biological | PULSAR + DT +/- Pembrolizumab |
| Pulsed Stereotactic Ablative RadiotherapyAlso: PULSARPULSAR is a radiation treatment (10Gy x 1 fraction) administered up to 3 times in the neoadjuvant setting. | Radiation | PULSAR + DT +/- Pembrolizumab |
| EthosEthos is a unique ring-gantry CT-guided linear accelerator notable for having a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy. | Device | PULSAR + DT +/- Pembrolizumab |
Primary outcome
Rate of 30-day mortality
Time frame: Within 30 days after any administered PULSAR fraction (up to approximately 9 weeks)
Defined as death considered possibly, probably, or definitely related to PULSAR-DT +/- pembrolizumab occurring within 30 days after any administered PULSAR fraction. The treatment-related mortality rate will be calculated as the number of participants experiencing a qualifying death divided by the total number of participants in the Safety Analysis Set (all enrolled participants who receive at least one fraction or dose of any treatment, including PULSAR, dabrafenib, trametinib, or pembrolizumab) and will be presented with an exact binomial 95% confidence interval (CI).
Objective response rate (ORR) at 1st restaging
Time frame: At 1st restaging (estimated to be 4 weeks)
ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as assessed by RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Objective response rate (ORR) at 2nd restaging
Time frame: At 2nd restaging (estimated to be 13-14 weeks)
ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as assessed by RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
4 secondary outcomes
Feasibility as measured by the total percentage of participants who are able to undergo surgical resection following completion of neoadjuvant PULSAR-DT +/- pembrolizumab
Time frame: Baseline until completion of surgery (total estimated time 5-19 weeks)
Pill compliance - dabrafenib
Time frame: Start of dabrafenib treatment to completion of treatment (total estimated time 9 weeks)
Pill compliance - trametinib
Time frame: Start of trametinib treatment to completion of treatment (total estimated time 9 weeks)
Number of planned PULSAR pulses completed by participants
Time frame: At completion of PULSAR (estimated to be 5 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 21 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in any publication or presentation arising from this study may be made available to qualified external researchers. All requests for data sharing are subject to prior review \& written approval by the study Principal Investigator (PI) before any data are released. No individual participant data will be shared without advance consultation with, \& documented authorization from, the PI. Data will be shared only for scientifically sound proposals that are consistent with the consent provided by study participants, that do not overlap with analyses planned or ongoing by the study team, \& that comply with all applicable institutional, IRB, privacy (e.g., HIPAA), \& data-use requirements. All released datasets will be de-identified in accordance with applicable regulations, \& a data-use agreement (DUA) executed between the requesting institution \& the sponsoring institution will be required prior to transfer.
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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.
Nikhil Rammohan, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dabrafenib, Trametinib and Pembrolizumab in people with Anaplastic Thyroid Carcinoma and Thyroid Cancer, run by Washington University School of Medicine 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 16 inclusion and 17 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: opening soon, as of the sponsor's last update on 21 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Nikhil Rammohan, MD, PhD (314-565-5941, nikhilr@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 30-day mortality (time frame: Within 30 days after any administered PULSAR fraction (up to approximately 9 weeks)). The study lists 3 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 21 Oct 2026.