Muscle Invasive Bladder CarcinomaPhase 2NCT05406713
Pembrolizumab in Muscle-invasive Bladder Cancer
A Phase 2 study testing Pembrolizumab in people with Muscle Invasive Bladder Carcinoma and Localized Cancer, run by Matthew Galsky at 4 sites in United States.
Trial summary
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Carcinoma, Localized Cancer, Urothelial Carcinoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Jul 2022to 31 Jan 2028
- 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
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 1 within 28 days prior to registration.
- Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder. Clinical stage cT2-3N0M0. N0 will be considered the absence of radiographically enlarged lymph nodes on baseline imaging. Patients with lymph nodes <1 cm in long axis on imaging may be eligible but must be discussed with the sponsor investigator.
- Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 60 days prior C1D1. Maximal TURBT is defined as a macroscopically complete resection of bladder tumor when safely possibly per the treating urologist. Patients who cannot safely undergo maximal TURBT as per their treating urologist are eligible for enrollment but should be discussed with the sponsor investigator.
Show all 26Show fewer
- All subjects must have adequate transurethral resection of bladder tumor tissue available for submission (i.e., at least 15 unstained slides or paraffin block) identified during screening. This tissue can be from the maximal restaging TURBT, a prior diagnostic TURBT revealing muscle-invasive bladder cancer, or both specimens. Subjects without available archival tissue must be discussed with the sponsor-investigator.
- Decline cisplatin-based neoadjuvant chemotherapy or be considered cisplatin-ineligible based on at least one of the following modified criteria (as ECOG 0-1 is required for eligibility):
- Creatinine clearance < 60 mL/min (but ≥ 30 mL/min)
- Grade ≥ 2 hearing loss (per CTCAE criteria v5)
- Grade ≥ 2 neuropathy (per CTCAE criteria v5)
- New York Heart Association Class III heart failure
- Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
- Hematological
- Absolute Neutrophil Count (ANC): ≥ 1.5 x 10^9/L
- Hemoglobin (Hgb): ≥ 9 g/dL
- Platelets: ≥ 100 x 10^9/L
- Renal
- Creatinine OR: Creatinine ≤ 1.5 × ULN OR
- Calculated creatinine clearance: creatinine clearance ≥ 30 mL/min
- Hepatic
- Bilirubin: ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN
- Aspartate aminotransferase (AST): ≤ 2.5 × ULN
- Alanine aminotransferase (ALT): ≤ 2.5 × ULN
- Women of childbearing potential (WOCP) must have a negative serum or urine pregnancy test a maximum of 24-hours before the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. WOCBP must agree to use contraception.
- A male participant must agree to use contraception.
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured. Patients with intermediate or lower risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN) risk stratification guidelines may be eligible for enrollment.
- Prior radiation therapy for bladder cancer.
- Active infection requiring systemic therapy.
- Has a known history of Hepatitis B or C. NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. NOTE: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
Show all 18Show fewer
- Has a known history of Human Immunodeficiency Virus (HIV) infection. NOTE: no testing for HIV is required unless mandated by local health authority.
- Has a known history of active TB (Bacillus Tuberculosis).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has had an allogenic tissue/solid organ transplant.
- Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
City of Hope
Duarte, California, 91010
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Neoadjuvant Pembrolizumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol.
Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
- Being tested
- Pembrolizumab
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
400 mg intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Cycles 1-2 (Pembrolizumab): 400 mg of Pembrolizumab intravenously (Administered Day 1 of 42 day Cycle)
If complete response of treatment is observed then maintenance therapy will be given. All other patients will receive with standard of care local therapy (cystectomy or chemo-radiation) as per their treating physicians followed by "adjuvant" pembrolizumab.
Cycle 3-9 (Maintenance or Adjuvant Single agent Pembrolizumab): 400 mg of Pembrolizumab intravenously (Administered Day 1 of 42 day Cycle) Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response Rate (CRR)
Estimate the clinical complete response rate defined as cT0 or cTa disease after pembrolizumab
Measured: 2 years
Benefit from Treatment
Estimate the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment. For patients achieving a clinical complete response, benefit will be defined as 2 year metastasis-free survival in patients among the patients achieving a clinical complete response.
Measured: 2 years
Secondary outcomes (20)
Assess adverse events
Describe the safety of neoadjuvant pembrolizumab.Safety will be determined according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Measured: 6 months
Positive Predictive Value between PD-L1 Expression and clinical complete response
Positive predictive value of PD-L1 CPS, in predicting benefit from treatment in patients achieving a clinical complete response. Combined Positive Score (CPS) is defined as the number of PD-L1 staining cells divided by the total number of viable tumor cells, multiplied by 100.
Measured: 2 years
Positive Predictive Value between TMB and clinical complete response
Positive predictive value of TMB in predicting benefit from treatment in patients achieving a clinical complete response. Tumor mutational burden (TMB) is defined as the total number of somatic nonsynonymous mutations per coding area of a tumor genome.
Measured: 2 years
Metastasis Free Survival
Estimate metastasis free survival in the overall study population. Metastasis-free survival is defined as the time from initiation of treatment to the development of metastatic disease. Microscopic metastatic disease involving regional lymph nodes resected at cystectomy performed with curative intent will not be considered an event. Confirmation of metastatic recurrence with a biopsy is recommended in all situations.
Measured: 2 years
Metastasis Free Survival
Estimate the 2 year metastasis-free survival. Metastasis-free survival is defined as the time from initiation of treatment to the development of metastatic disease. Microscopic metastatic disease involving regional lymph nodes resected at cystectomy performed with curative intent will not be considered an event. Confirmation of metastatic recurrence with a biopsy is recommended in all situations.
Measured: 2 years
Metastasis Free Survival
Estimate metastasis free survival in patients achieving a clinical complete response. Metastasis-free survival is defined as the time from initiation of treatment to the development of metastatic disease. Microscopic metastatic disease involving regional lymph nodes resected at cystectomy performed with curative intent will not be considered an event. Confirmation of metastatic recurrence with a biopsy is recommended in all situations.
Measured: 2 years
Metastasis Free Survival
Estimate metastasis free survival in patients not achieving a clinical complete response. Metastasis-free survival is defined as the time from initiation of treatment to the development of metastatic disease. Microscopic metastatic disease involving regional lymph nodes resected at cystectomy performed with curative intent will not be considered an event. Confirmation of metastatic recurrence with a biopsy is recommended in all situations.
Measured: 2 years
Bladder-intact Event Free Survival
Bladder-intact event-free survival is defined from initiation of treatment until radical cystectomy, evidence of unresectable or metastatic disease, or death due to any cause.
Measured: 2 years
Bladder-intact Event Free Survival
Estimate bladder-intact event free survival in patients achieving a clinical complete response. Bladder-intact event-free survival is defined from initiation of treatment until radical cystectomy, evidence of unresectable or metastatic disease, or death due to any cause.
Measured: 2 years
Bladder-intact Event Free Survival
Estimate bladder-intact event free survival in patients not achieving a clinical complete response. Bladder-intact event-free survival is defined from initiation of treatment until radical cystectomy, evidence of unresectable or metastatic disease, or death due to any cause.
Measured: 2 years
Overall Survival (OS)
Estimate overall survival. Overall survival is defined as the time from initiation of treatment to death.
Measured: 2 years
Overall Survival (OS)
Estimate overall survival in patients achieving a clinical complete response. Overall survival is defined as the time from initiation of treatment to death.
Measured: 2 years
Overall Survival (OS)
Estimate overall survival in patients not achieving a clinical complete response. Overall survival is defined as the time from initiation of treatment to death.
Measured: 2 years
Bladder-Intact Overall Survival
Estimate bladder-intact overall survival. Bladder-intact overall survival is defined as the time from initiation of treatment until death or cystectomy.
Measured: 2 years
Bladder-Intact Overall Survival
Estimate bladder-intact overall survival in patients achieving a clinical complete response. Bladder-intact overall survival is defined as the time from initiation of treatment until death or cystectomy.
Measured: 2 years
Bladder-Intact Overall Survival
Estimate bladder-intact overall survival in patients not achieving a clinical complete response. Bladder-intact overall survival is defined as the time from initiation of treatment until death or cystectomy.
Measured: 2 years
Invasive Bladder Recurrence Free Survival
Estimate invasive bladder recurrence-free survival in patients achieving a clinical complete response and in all patients not undergoing cystectomy. Invasive bladder recurrence free survival will be defined as the time from initiation of treatment to the development of at least cT/pT1 urothelial cancer in the bladder.
Measured: 2 years
Recurrence Free Survival (RFS)
Estimate the RFS. Recurrence-free survival is defined as the time from initiation of treatment to death or recurrence, depending on which occurs first.
Measured: 2 years
Recurrence Free Survival (RFS)
Estimate the RFS in patients achieving a clinical complete response. Recurrence-free survival is defined as the time from initiation of treatment to death or recurrence, depending on which occurs first.
Measured: 2 years
Recurrence Free Survival (RFS)
Estimate the RFS in patients not achieving a clinical complete response. Recurrence-free survival is defined as the time from initiation of treatment to death or recurrence, depending on which occurs first.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start13 Jul 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Galsky
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Matthew Galsky, Hoosier Cancer Research Network
- Investigators
- Matthew D Galsky, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406713
- Sponsor's protocol ID
- HCRN GU20-444
- Status last verified
- Apr 2026
- First submitted
- 9 May 2022
- Last updated
- 8 Apr 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Pembrolizumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
- ClinicalTrials.gov ID
- NCT05406713
- Acronym / sponsor ID
- HCRN GU20-444
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Matthew GalskyUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Jun 2022 (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.
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol.
Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: PembrolizumabCycles 1-2 (Pembrolizumab): 400 mg of Pembrolizumab intravenously (Administered Day 1 of 42 day Cycle) If complete response of treatment is observed then maintenance therapy will be given. All other patients will receive with standard of care local therapy (cystectomy or chemo-radiation) as per their treating physicians followed by "adjuvant" pembrolizumab. Cycle 3-9 (Maintenance or Adjuvant Single agent Pembrolizumab): 400 mg of Pembrolizumab intravenously (Administered Day 1 of 42 day Cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 1 within 28 days prior to registration.
- Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder. Clinical stage cT2-3N0M0. N0 will be considered the absence of radiographically enlarged lymph nodes on baseline imaging. Patients with lymph nodes <1 cm in long axis on imaging may be eligible but must be discussed with the sponsor investigator.
Key exclusion criteria (18 listed)
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured. Patients with intermediate or lower risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN) risk stratification guidelines may be eligible for enrollment.
- Prior radiation therapy for bladder cancer.
- Active infection requiring systemic therapy.
- Has a known history of Hepatitis B or C. NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. NOTE: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
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 |
|---|---|---|
| PembrolizumabAlso: Keytruda400 mg intravenously | Drug | Experimental Group |
Primary outcome
Clinical Complete Response Rate (CRR)
Time frame: 2 years
Estimate the clinical complete response rate defined as cT0 or cTa disease after pembrolizumab
Benefit from Treatment
Time frame: 2 years
Estimate the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment. For patients achieving a clinical complete response, benefit will be defined as 2 year metastasis-free survival in patients among the patients achieving a clinical complete response.
20 secondary outcomes
Assess adverse events
Time frame: 6 months
Positive Predictive Value between PD-L1 Expression and clinical complete response
Time frame: 2 years
Positive Predictive Value between TMB and clinical complete response
Time frame: 2 years
Metastasis Free Survival
Time frame: 2 years
Metastasis Free Survival
Time frame: 2 years
Metastasis Free Survival
Time frame: 2 years
Metastasis Free Survival
Time frame: 2 years
Bladder-intact Event Free Survival
Time frame: 2 years
Bladder-intact Event Free Survival
Time frame: 2 years
Bladder-intact Event Free Survival
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Bladder-Intact Overall Survival
Time frame: 2 years
Bladder-Intact Overall Survival
Time frame: 2 years
Bladder-Intact Overall Survival
Time frame: 2 years
Invasive Bladder Recurrence Free Survival
Time frame: 2 years
Recurrence Free Survival (RFS)
Time frame: 2 years
Recurrence Free Survival (RFS)
Time frame: 2 years
Recurrence Free Survival (RFS)
Time frame: 2 years
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 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Muscle Invasive Bladder Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingObservational study
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Non-Muscle Invasive Bladder Cancer
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.
Matthew D Galsky, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Muscle Invasive Bladder Carcinoma and Localized Cancer, run by Matthew Galsky at 4 sites 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 26 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 Rate (CRR) (time frame: 2 years). 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 8 Apr 2026.