Bladder CancerPhase 2NeoSTOP-ITNCT06571708
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
A Phase 2 study testing Gemcitabine, Cisplatin and Cemiplimab in people with Bladder Cancer and Muscle-Invasive Bladder Carcinoma, run by Columbia University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer? Participants will be randomly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma
- What is being tested?
- Gemcitabine, Cisplatin and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 5 Jan 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Life expectancy > 12 months.
- Performance status of 0-1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder defined as T2-T3, N0, M0 stage. Mixed histology is permitted if there is a urothelial component. Upper tract disease in not permitted.
- Prior Bacillus Calmette-Guerin (BCG) or other intravesical treatment of non-muscle invasive bladder cancer is permitted if completed at least 6 weeks prior to initiating study treatment. Only one course (includes induction + maintenance) of BCG or intravesical therapy is permitted.
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- No metastatic disease based on cross-sectional imaging.
- Considered cisplatin eligible based on protocol specified criteria.
- Not received any adjuvant or neoadjuvant chemotherapy or immunotherapy.
- Agree to pre- and post-treatment TURBT as well as surveillance with cystoscopies, cross-sectional imaging, and urine cytology unless medically contraindicated in the opinion of the treating physician, and discussed with the principal investigator
Who cannot join
- Concurrent upper urinary tract (i.e., ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible).
- Received prior immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-LAG-3 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways ), as well as cellular vaccines, cellular therapies, or systemic oncolytic virus therapy.
- Received bladder-directed radiation therapy previously for bladder cancer.
- Received prior systemic chemotherapy for muscle-invasive bladder cancer.
- Receiving any other investigational agents concurrently or within 4 weeks of start of treatment.
- Had a solid organ or hematologic transplant.
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- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose greater than 10mg/day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Has a history of myocarditis.
- Patients with another active second malignancy other than non-melanoma skin cancers.
- Has a known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis.
- Has an active infection requiring systemic therapy.
- History or current evidence of significant (Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
- Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator, including dialysis.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
- Is pregnant or is a breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
About this study
Official title: A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer?
Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab.
Read more
Participants will:
- Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles)
- After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging
- Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months
- Participants without a complete clinical response will undergo cystectomy (bladder surgery).
Read the detailed description
This is a phase 2, open-label, randomized trial with continuous toxicity monitoring to ensure safety using Bayesian toxicity monitoring, which will evaluate treatment with doublet platinum-based chemotherapy (gemcitabine and cisplatin) plus cemiplimab (REGN2810) with or without fianlimab (REGN3767) for localized muscle-invasive bladder cancer (MIBC). Participants will be randomized to 4 cycles of 3 weeks each (12 weeks total) with gemcitabine, cisplatin, and cemiplimab with or without fianlimab. Participants achieving a clinical complete response will continue 13 more cycles of immunotherapy (39 weeks total). The total duration of systemic treatment, including neoadjuvant therapy, will be 52 weeks.
In addition to the actual time on treatment, there will be time off treatment for recovery after neoadjuvant treatment and before adjuvant treatment. First, between the neoadjuvant phase and cystoscopy (with TURBT for residual disease), there will be up to 4 weeks off treatment. In between the cystoscopy/TURBT and start of adjuvant immunotherapy, there will be an additional up to 4 week interval for recovery. Participants will have regularly scheduled study visits at the clinical site on Day 1 and Day 8 of every three-week cycle in the neoadjuvant setting, where continuous assessment, including treatment response and safety assessments, will be performed. These will include laboratory tests, taking of vital signs, and physical examinations. In the adjuvant setting for participants who continue to maintenance immunotherapy, participants will have regularly scheduled study visits at the clinical site on Day 1 of every three-week cycle.
Response to treatment will be determined by three modalities. First, CT scans (chest, abdomen, and pelvis with and without contrast) to ensure no metastatic disease. For participants who are unable to get a CT scan w/ contrast due to renal function (or any other reason), an MRI with and without contrast may be used instead. Scans are required at baseline and every 3 months in the adjuvant setting for participants who continue on with maintenance immunotherapy. Second, all participants will undergo post-treatment cystoscopy every 3 months while on treatment. Third, all participants will undergo post-treatment urine cytology every 3 months while on treatment.
- Conditions
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma
- Being tested
- Gemcitabine, Cisplatin, Cemiplimab, Fianlimab
- Keywords
- Urothelial Predominant Histology
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine 1000 mg/m^2 IV
CisplatinDrug
Cisplatin 70 mg/m^2 IV or renally-dosed split-dose cisplatin 35 m/m^2 IV
CemiplimabDrug
Also called REGN 2810
Cemiplimab 350mg IV
FianlimabDrug
Also called REGN3767
Fianlimab 1600mg IV
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Gemcitabine/Cisplatin/Cemiplimab | Experimental | * Gemcitabine 1000 mg/m^2 IV (days 1 and 8 of 21 day for 4 cycles)
* Cisplatin 70 mg/m^2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose -cisplatin 35 m/m^2 IV (day 1 and 8 of 21 day cycle for 4 cycles)
* Cemiplimab (REGN 2810) 350 mg IV every 3 weeks (17 cycles) Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Cemiplimab |
| Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab | Experimental | * Gemcitabine 1000 mg/m2 IV (days 1 and 8 of 21 day cycle for 4 cycles)
* Cisplatin 70 mg/m2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose cisplatin 35 m/m2 IV (day 1 and 8 of 21 day cycle for 4 cycles )
* Cemiplimab (REGN 2810) 350mg IV every 3 weeks (4 cycles)
* Fianlimab (REGN3767) 1600mg IV every 3 weeks (4 cycles) Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Cemiplimab; Drug: Fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response
Rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy. Complete clinical response will be defined as:
- No high-grade malignancy on repeat TURBT
- No malignant cells on urine cytology
- No definitive evidence of invasive local or metastatic disease on cross-sectional imaging (CT chest, abdomen, and pelvis with contrast or, if renal dysfunction, MRI with contrast)
Cytoscopy and imaging should occur within 4 weeks of end of neoadjuvant therapy.
Measured: 16 weeks
Secondary outcomes (4)
Number of Adverse Events
Defined as the occurrence of any adverse event (AE) related to the investigational drugs at any point on treatment until 30 days after the last dose of treatment. AEs as evaluated per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 30 days after last dose of treatment, up to 56 weeks
Bladder-intact Survival
Bladder-intact survival is defined as the time from start of treatment until cystectomy or death.
Measured: Up to 5 years
Recurrence-free Survival
Recurrence-free survival is defined as the time from start of treatment until disease recurrence or death. Recurrence-survival will only be measured in patients who achieve a clinical complete response.
Measured: Up to 5 years
Overall Survival
Overall survival is defined as the time from start of treatment until death.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start14 Aug 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Why it stopped: Change in standard of care treatment for muscle-invasive bladder cancer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Alexander Z. Wei, MD, Columbia University
- Investigators
- Alexander Z Wei, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571708
- Sponsor's protocol ID
- AAAV3927
- Acronym
- NeoSTOP-IT
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2024
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
- ClinicalTrials.gov ID
- NCT06571708
- Acronym / sponsor ID
- NeoSTOP-IT / AAAV3927
- Conditions
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma
- Keywords
- Urothelial Predominant Histology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in standard of care treatment for muscle-invasive bladder cancer
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Posted 3 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer?
Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab.
Participants will:
- Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles)
- After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging
- Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months
- Participants without a complete clinical response will undergo cystectomy (bladder surgery).
Detailed description
This is a phase 2, open-label, randomized trial with continuous toxicity monitoring to ensure safety using Bayesian toxicity monitoring, which will evaluate treatment with doublet platinum-based chemotherapy (gemcitabine and cisplatin) plus cemiplimab (REGN2810) with or without fianlimab (REGN3767) for localized muscle-invasive bladder cancer (MIBC). Participants will be randomized to 4 cycles of 3 weeks each (12 weeks total) with gemcitabine, cisplatin, and cemiplimab with or without fianlimab. Participants achieving a clinical complete response will continue 13 more cycles of immunotherapy (39 weeks total). The total duration of systemic treatment, including neoadjuvant therapy, will be 52 weeks.
In addition to the actual time on treatment, there will be time off treatment for recovery after neoadjuvant treatment and before adjuvant treatment. First, between the neoadjuvant phase and cystoscopy (with TURBT for residual disease), there will be up to 4 weeks off treatment. In between the cystoscopy/TURBT and start of adjuvant immunotherapy, there will be an additional up to 4 week interval for recovery. Participants will have regularly scheduled study visits at the clinical site on Day 1 and Day 8 of every three-week cycle in the neoadjuvant setting, where continuous assessment, including treatment response and safety assessments, will be performed. These will include laboratory tests, taking of vital signs, and physical examinations. In the adjuvant setting for participants who continue to maintenance immunotherapy, participants will have regularly scheduled study visits at the clinical site on Day 1 of every three-week cycle.
Response to treatment will be determined by three modalities. First, CT scans (chest, abdomen, and pelvis with and without contrast) to ensure no metastatic disease. For participants who are unable to get a CT scan w/ contrast due to renal function (or any other reason), an MRI with and without contrast may be used instead. Scans are required at baseline and every 3 months in the adjuvant setting for participants who continue on with maintenance immunotherapy. Second, all participants will undergo post-treatment cystoscopy every 3 months while on treatment. Third, all participants will undergo post-treatment urine cytology every 3 months while on treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Gemcitabine/Cisplatin/Cemiplimab | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Drug: Cemiplimab* Gemcitabine 1000 mg/m^2 IV (days 1 and 8 of 21 day for 4 cycles) * Cisplatin 70 mg/m^2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose -cisplatin 35 m/m^2 IV (day 1 and 8 of 21 day cycle for 4 cycles) * Cemiplimab (REGN 2810) 350 mg IV every 3 weeks (17 cycles) |
| Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Drug: Cemiplimab, Drug: Fianlimab* Gemcitabine 1000 mg/m2 IV (days 1 and 8 of 21 day cycle for 4 cycles) * Cisplatin 70 mg/m2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose cisplatin 35 m/m2 IV (day 1 and 8 of 21 day cycle for 4 cycles ) * Cemiplimab (REGN 2810) 350mg IV every 3 weeks (4 cycles) * Fianlimab (REGN3767) 1600mg IV every 3 weeks (4 cycles) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Life expectancy > 12 months.
- Performance status of 0-1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder defined as T2-T3, N0, M0 stage. Mixed histology is permitted if there is a urothelial component. Upper tract disease in not permitted.
Key exclusion criteria (17 listed)
- Concurrent upper urinary tract (i.e., ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible).
- Received prior immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-LAG-3 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways ), as well as cellular vaccines, cellular therapies, or systemic oncolytic virus therapy.
- Received bladder-directed radiation therapy previously for bladder cancer.
- Received prior systemic chemotherapy for muscle-invasive bladder cancer.
- Receiving any other investigational agents concurrently or within 4 weeks of start of treatment.
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 |
|---|---|---|
| GemcitabineGemcitabine 1000 mg/m^2 IV | Drug | Group 1: Gemcitabine/Cisplatin/Cemiplimab, Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab |
| CisplatinCisplatin 70 mg/m^2 IV or renally-dosed split-dose cisplatin 35 m/m^2 IV | Drug | Group 1: Gemcitabine/Cisplatin/Cemiplimab, Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab |
| CemiplimabAlso: REGN 2810Cemiplimab 350mg IV | Drug | Group 1: Gemcitabine/Cisplatin/Cemiplimab, Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab |
| FianlimabAlso: REGN3767Fianlimab 1600mg IV | Drug | Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab |
Primary outcome
Clinical Complete Response
Time frame: 16 weeks
Rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy. Complete clinical response will be defined as: * No high-grade malignancy on repeat TURBT * No malignant cells on urine cytology * No definitive evidence of invasive local or metastatic disease on cross-sectional imaging (CT chest, abdomen, and pelvis with contrast or, if renal dysfunction, MRI with contrast) Cytoscopy and imaging should occur within 4 weeks of end of neoadjuvant therapy.
4 secondary outcomes
Number of Adverse Events
Time frame: 30 days after last dose of treatment, up to 56 weeks
Bladder-intact Survival
Time frame: Up to 5 years
Recurrence-free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Alexander Z Wei, 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 2 study testing Gemcitabine, Cisplatin and Cemiplimab in people with Bladder Cancer and Muscle-Invasive Bladder Carcinoma, run by Columbia University 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 10 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: stopped early, as of the sponsor's last update on 3 Nov 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?
Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Complete Response (time frame: 16 weeks). 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 3 Nov 2026.