Metastatic Urothelial CarcinomaPhase 2IMPROEVNCT07221942
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
A Phase 2 study testing Enfortumab vedotin and Pembrolizumab in people with Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Advanced Urothelial Carcinoma
- What is being tested?
- Enfortumab vedotin and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to 3 Sep 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
- Patients must have histologically and radiographically confirmed locally advanced, unresectable urothelial carcinoma.
- Patients should not have received prior systemic therapy for metastatic disease.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1
- Patients may have received prior neoadjuvant or adjuvant immune checkpoint inhibitor therapy for localized disease and are eligible if they completed the treatment ≥12 months prior to initiating treatment on this clinical trial.
- ECOG performance status 0-2
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
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- Archival tumor biospecimen (when available) must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study. Formalin fixed, paraffin embedded (FFPE) tissue block(s) or at least 25 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.
- Normal organ and marrow function as defined below.
- Absolute neutrophil count > 1,000/mm3 unless patient has constitutional neutropenia
- Platelets > 100,000/µl
- Hemoglobin > 8.0 g/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) or <3.5 x ULN if liver metastases
- Creatinine Clearance >20 ml/min
Who cannot join
- Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) for urothelial cancer.
- Grade 2 or higher baseline sensory or motor neuropathy.
- Uncontrolled diabetes (HbA1c >8%)
- Patients with uncontrolled and untreated central nervous system (CNS) metastases.
- Prior radiation to CNS metastases is permitted.
- Prior history of CNS disease that has responded to previous systemic therapy is permitted only if no recurrence.
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- Patient should not have leptomeningeal disease
- CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.
- If requiring steroid treatment for CNS metastases, the patient is on stable dose < 10 mg/day of prednisone or equivalent for at least 2 weeks prior to starting treatment
- Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would substantially impair the patient's ability to comply with study requirements. Efforts should be made to provide reasonable accommodations before determining exclusion based on social limitations.
- Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug that cannot be watched and requires treatment, or any evidence of residual disease from a previously diagnosed malignancy that cannot be watched and requires treatment. Adjuvant hormonal therapy for breast cancer is allowed.
- Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
- Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with enfortumab vedotin.
- History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Prior allogeneic stem cell or solid organ transplant.
- Other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.
- Patients with active tuberculosis.
- Pregnant or breast feeding
- History of autoimmune diseases. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Patients with vitiligo or residual autoimmune hypothyroidism on stable doses of hormone replacement are permitted to enroll.
- Patients with type 1 diabetes mellitus (T1DM) on a stable dose of insulin are permitted to enroll.
- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- On high dose steroids at the time of study enrollment, defined as >10 mg prednisone (or bioequivalent), including steroids used for management of intracranial lesions. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
- Patients who received prior immunotherapy for mUC or for an alternative malignancy are eligible unless they developed an immune related adverse event while on therapy requiring cessation of therapy or use of disease modifying agents, corticosteroids, or immunosuppressive drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Pooja Ghatalia, MD, Pooja.Ghatalia@tuhs.temple.edu
About this study
Official title: Pembrolizumab Maintenance After Enfortumab Vedotin/Pembrolizumab Induction in Front-Line Metastatic Urothelial Carcinoma
This is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled. Induction consists of EV (1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg/kg allowed) and P (200 mg IV on Day 1 of each cycle). Radiographic assessments occur after 3 and 6 cycles. Patients achieving complete or partial response transition to maintenance P (400 mg IV every 6 weeks or 200 mg IV every 3 weeks) for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for P. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients will enter long-term or survival follow-up as applicable.
Read the detailed description
This is a single-arm, open-label, non-randomized Phase II trial designed to evaluate the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled, with recruitment anticipated to begin in 2025.
Induction Phase (18 weeks):
Patients will receive EV (1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg/kg allowed per physician discretion) and P (200 mg IV on Day 1 of each cycle). The first radiographic assessment will occur after 3 cycles (approximately 9 weeks). Patients demonstrating clinical benefit (CR or PR per RECIST v1.1) will receive 3 additional cycles of EV/P, followed by a second radiographic assessment after 6 cycles (approximately 18 weeks). Patients achieving CR or PR will transition to the maintenance phase. Patients with stable disease may continue EV/P or transition to maintenance P based on patient/physician discretion. Patients experiencing progression during induction may seek alternative treatments.
Maintenance Phase:
Responding patients (CR/PR) will receive P at 400 mg IV every 6 weeks for up to 2 years, or 200 mg IV every 3 weeks per physician preference. The 2-year duration aligns with the maximum pembrolizumab exposure in EV-302. Radiographic assessments will occur every 12 weeks during maintenance. Patients will continue treatment until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients progressing on P maintenance may resume EV.
Follow-Up:
Patients will enter Survival Follow-up upon progression or toxicity requiring cessation of therapy. If a patient discontinues one drug due to toxicity or near complete response, they may continue on the other drug and remain on study. Both drugs may be discontinued early for toxicity or near complete response at physician discretion; these patients enter Long-term Follow-up. Patients who resume therapy after early discontinuation remain in Long-term Follow-up until progression, then transition to Survival Follow-up. Patients with suboptimal disease control or progression after EV schedule de-escalation may return to the original EV schedule at the highest tolerated dose per physician discretion. Dose adjustments for EV (1.25 mg/kg → 1 mg/kg → 0.75 mg/kg) are permitted per EV-302 guidelines. No dose adjustments for P will be made. Treatment may be held for up to 8 weeks for toxicity management; if held beyond 8 weeks, patients enter Long-term Follow-up.
- Conditions
- Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Advanced Urothelial Carcinoma
- Being tested
- Enfortumab vedotin, Pembrolizumab
- Keywords
- Urothelial carcinoma
- 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.
Enfortumab vedotinDrug
EV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle
PembrolizumabDrug
Pembrolizumab will be administered at 200 mg IV on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Induction EV + Pembrolizumab Followed by Maintenance Pembrolizumab | Experimental | Participants will receive induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 6 cycles (approximately 18 weeks). EV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle (starting dose of 1 mg/kg allowed), and pembrolizumab at 200 mg IV on Day 1 of each cycle. Patients achieving complete or partial response will transition to maintenance pembrolizumab at 400 mg IV every 6 weeks or 200 mg IV every 3 weeks for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for pembrolizumab. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. Receives: Drug: Enfortumab vedotin; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
18-month progression-free survival (PFS)
radiographic progression or death from any cause within 18 months of initiating treatment
Measured: 18 months
Secondary outcomes (7)
Overall Survival (OS)
Time from initiating treatment to death from any cause, to capture long-term survival benefits
Measured: 4 years
Duration of Response (DoR)
Time from first objective response (CR/PR) to radiographic progression or death, providing insight into the sustained efficacy of the treatment
Measured: 4 years
PFS 2 after EV rechallenge
Since patients progressing after completing induction EV/P will be able to receive EV re-challenge, we will measure PFS with EV rechallenge measured from the start of EV rechallenge to the next progression defined by RECIST 1.1 or death
Measured: 4 years
Treatment-free interval
Time from the completion of induction EV/P to either EV re-initiation or the start of another therapy, measuring how long patients remain off treatment
Measured: 4 years
Incidence of Peripheral neuropathy
Changes in neuropathy-related symptoms will be assessed using the EORTC QLQ-CIPN20 survey, which evaluates sensory, motor, and autonomic neuropathy symptoms
Measured: 4 years
Quality of Life (QoL) using EORTC QLQ-C30 (European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire)
Assessed using EORTC QLQ-C30 questionnaire; higher scores indicate better global health status
Measured: 4 years
Quality of Life (QoL) using QLQ-BLM30
QLQ-BLM30 a disease-specific module designed to assess health-related quality of life in patients with muscle-invasive bladder cancer. Higher scores indicate more symptoms, which means a worse outcome.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start23 Jan 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion3 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Pooja Ghatalia, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221942
- Sponsor's protocol ID
- 25-1029
- Other IDs
- GU-229
- Acronym
- IMPROEV
- Status last verified
- Feb 2026
- First submitted
- 17 Oct 2025
- Last updated
- 19 Feb 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pembrolizumab Maintenance After Enfortumab Vedotin/Pembrolizumab Induction in Front-Line Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07221942
- Acronym / sponsor ID
- IMPROEV / 25-1029
- Conditions
- Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Advanced Urothelial Carcinoma
- Keywords
- Urothelial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 3 Sep 2029 (estimated)
- First posted
- 29 Oct 2025 (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 is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled. Induction consists of EV (1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg/kg allowed) and P (200 mg IV on Day 1 of each cycle). Radiographic assessments occur after 3 and 6 cycles. Patients achieving complete or partial response transition to maintenance P (400 mg IV every 6 weeks or 200 mg IV every 3 weeks) for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for P. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients will enter long-term or survival follow-up as applicable.
Detailed description
This is a single-arm, open-label, non-randomized Phase II trial designed to evaluate the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled, with recruitment anticipated to begin in 2025.
Induction Phase (18 weeks):
Patients will receive EV (1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg/kg allowed per physician discretion) and P (200 mg IV on Day 1 of each cycle). The first radiographic assessment will occur after 3 cycles (approximately 9 weeks). Patients demonstrating clinical benefit (CR or PR per RECIST v1.1) will receive 3 additional cycles of EV/P, followed by a second radiographic assessment after 6 cycles (approximately 18 weeks). Patients achieving CR or PR will transition to the maintenance phase. Patients with stable disease may continue EV/P or transition to maintenance P based on patient/physician discretion. Patients experiencing progression during induction may seek alternative treatments.
Maintenance Phase:
Responding patients (CR/PR) will receive P at 400 mg IV every 6 weeks for up to 2 years, or 200 mg IV every 3 weeks per physician preference. The 2-year duration aligns with the maximum pembrolizumab exposure in EV-302. Radiographic assessments will occur every 12 weeks during maintenance. Patients will continue treatment until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients progressing on P maintenance may resume EV.
Follow-Up:
Patients will enter Survival Follow-up upon progression or toxicity requiring cessation of therapy. If a patient discontinues one drug due to toxicity or near complete response, they may continue on the other drug and remain on study. Both drugs may be discontinued early for toxicity or near complete response at physician discretion; these patients enter Long-term Follow-up. Patients who resume therapy after early discontinuation remain in Long-term Follow-up until progression, then transition to Survival Follow-up. Patients with suboptimal disease control or progression after EV schedule de-escalation may return to the original EV schedule at the highest tolerated dose per physician discretion. Dose adjustments for EV (1.25 mg/kg → 1 mg/kg → 0.75 mg/kg) are permitted per EV-302 guidelines. No dose adjustments for P will be made. Treatment may be held for up to 8 weeks for toxicity management; if held beyond 8 weeks, patients enter Long-term Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction EV + Pembrolizumab Followed by Maintenance Pembrolizumab | Experimental | Drug: Enfortumab vedotin, Drug: PembrolizumabParticipants will receive induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 6 cycles (approximately 18 weeks). EV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle (starting dose of 1 mg/kg allowed), and pembrolizumab at 200 mg IV on Day 1 of each cycle. Patients achieving complete or partial response will transition to maintenance pembrolizumab at 400 mg IV every 6 weeks or 200 mg IV every 3 weeks for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for pembrolizumab. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histologically and radiographically confirmed locally advanced, unresectable urothelial carcinoma.
- Patients should not have received prior systemic therapy for metastatic disease.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1
- Patients may have received prior neoadjuvant or adjuvant immune checkpoint inhibitor therapy for localized disease and are eligible if they completed the treatment ≥12 months prior to initiating treatment on this clinical trial.
- ECOG performance status 0-2
Key exclusion criteria (24 listed)
- Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) for urothelial cancer.
- Grade 2 or higher baseline sensory or motor neuropathy.
- Uncontrolled diabetes (HbA1c >8%)
- Patients with uncontrolled and untreated central nervous system (CNS) metastases.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would substantially impair the patient's ability to comply with study requirements. Efforts should be made to provide reasonable accommodations before determining exclusion based on social limitations.
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 |
|---|---|---|
| Enfortumab vedotinEV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle | Drug | Induction EV + Pembrolizumab Followed by Maintenance Pembrolizumab |
| PembrolizumabPembrolizumab will be administered at 200 mg IV on Day 1 of each 21-day cycle | Drug | Induction EV + Pembrolizumab Followed by Maintenance Pembrolizumab |
Primary outcome
18-month progression-free survival (PFS)
Time frame: 18 months
radiographic progression or death from any cause within 18 months of initiating treatment
7 secondary outcomes
Overall Survival (OS)
Time frame: 4 years
Duration of Response (DoR)
Time frame: 4 years
PFS 2 after EV rechallenge
Time frame: 4 years
Treatment-free interval
Time frame: 4 years
Incidence of Peripheral neuropathy
Time frame: 4 years
Quality of Life (QoL) using EORTC QLQ-C30 (European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire)
Time frame: 4 years
Quality of Life (QoL) using QLQ-BLM30
Time frame: 4 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 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pooja Ghatalia, MD principal investigator
Fox Chase Cancer Center
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 Enfortumab vedotin and Pembrolizumab in people with Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, run by Fox Chase Cancer Center 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 13 inclusion and 24 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 19 Feb 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 Ryan Romasko, MBA (215-214-1515, ryan.romasko@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18-month progression-free survival (PFS) (time frame: 18 months). 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 19 Feb 2026.