Urothelial CarcinomaPhase 2NEPTUNENCT06356155
Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer
A Phase 2 study testing Enfortumab vedotin and Pembrolizumab in people with Urothelial Carcinoma, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial summary
This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2025to Mar 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
- Patients must have a diagnosis of high-grade upper tract (renal pelvis and/or ureter) urothelial carcinoma proven by biopsy or cytology within 60 days prior to registration with the following (cT1-4 N0-1 M0): a. Upper urinary tract mass on cross-sectional imaging or Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology. b. No regional lymph node metastasis, a single regional lymph node metastasis, or multiple regional lymph node metastases (no distant lymph node metastases)
- Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (≥50%) subtype is urothelial carcinoma.
- Patients must be considered to be a candidate for definitive surgery (nephroureterectomy or distal ureterectomy) with curative intent by the treating urologist. Lymph node dissection is strongly encouraged but its scope and determination will be at the discretion of the treating urologist. Details of the surgery such as bladder cuff removal are left to the discretion of the treating urologist. Robotic or open approaches are allowed.
- Prior local endoscopic therapy for upper tract urothelial cancer is permitted if completed at least 6 months prior to the initiation of study treatment and if all toxicities from such therapy have improved to grade 1 or resolved.
- Prior uro-oncologic history: a. History of or active non-invasive carcinoma or carcinoma in situ of the bladder/urethra or upper tract is allowed. b. Patients may have received prior intravesical chemotherapy or immunotherapy such as BCG. c. Prior neoadjuvant or adjuvant chemotherapy or antibody-drug conjugate for bladder cancer or invasive contralateral upper tract cancer is allowed but must have been completed ≥ 1 year prior to study registration.
- Patients must be age ≥ 18 on the date of registration.
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- ECOG Performance Status 0-1.
- Criteria for patients with hepatitis B or C are listed below. Hepatitis B and C screening tests are not required unless there is a known history of HBV or HCV infection or as mandated by local healthy authority. Hepatitis B positive subjects • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment. • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. • Participants must have completed curative anti-viral therapy at least 4 weeks prior to enrollment.
- Patients must have adequate organ and bone marrow function as defined in Table 1. Specimens must be collected within 14 business days prior to start of study enrollment.
- Women and men of reproductive potential must agree to use an effective contraceptive method during treatment and for 4 months after the last dose of study drug. See Section 16.3, Appendix 3. Men must also refrain from donating sperm during this period.
- Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration and are not breastfeeding.
- Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the treating oncologist.
- All patients must be informed of the investigational nature of this study. The patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a legally authorized representative or caregiver and/or family member available will also be considered eligible.
Who cannot join
- Prior exposure to immune-mediated therapy, including but not limited to, other anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4), anti-PD1, anti-PD-L1, anti-PD-L2 antibodies, and therapeutic anticancer vaccines.
- Prior exposure to monomethyl auristatin E antibody-drug conjugates (MMAE ADC).
- Patient is currently on or used immunosuppressive medication within 14 days prior to the first dose of pembrolizumab. The following are exceptions to this criterion: o Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g., intra-articular injection). o Use of chronic immunosuppressive agents at baseline at doses not to exceed more than prednisone 10 mg/day or equivalent. o Steroids as premedications for hypersensitivity reactions (e.g., CT scan premedication).
- Active or prior documented autoimmune or inflammatory disorders requiring immunosuppressive therapy within 2 years prior to registration. Exceptions are well-controlled hyper/hypothyroidism, celiac disease controlled by diet alone, diabetes mellitus type 1, alopecia, psoriasis, eczema, lichen planus, vitiligo, or similar skin/mucosa conditions.
- Evidence of metastasis (M1) on axial imaging at baseline.
- History of invasive, node positive, or metastatic bladder cancer OR invasive contralateral upper tract cancer within 2 years prior to registration.
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- Enrolled in another interventional clinical trial at the time of registration.
- Patient has another active malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 1 year. The time requirement does not apply to participants who underwent successful definitive resection of non-melanoma skin cancers, superficial bladder cancer (described above in inclusion criteria 6), in situ cervical cancer, other in situ cancers, or either clinically insignificant per the investigator (e.g., ≤Gleason 3+4) on surveillance or previously treated prostate cancer without rising PSA and no plan to treat. NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patient has one kidney.
- Patient is pregnant or lactating.
- Has severe hypersensitivity (≥ Grade 3) to enfortumab vedotin, pembrolizumab, and/or any of its excipients.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition 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 a known history of Human Immunodeficiency Virus (HIV) infection.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had an allogenic tissue (e.g., hematopoietic stem cell transplant HSCT)/solid organ transplant.
- Has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment.
- Has known active keratitis or corneal ulcerations
- Has any of the following: a. Moderate or severe liver dysfunction (does not meet hepatic function laboratory criteria outlined in Table 1). b. Uncontrolled diabetes mellitus as deemed by Hemoglobin A1c of 8 or greater. c. Grade ≥ 2 peripheral neuropathy. d. New York Heart Association Class III or higher heart failure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Irene Tsung, M.D., 734-936-4385, itsung@umich.edu
Irene Tsung, MD
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Elizabeth Plimack, 215-214-3925, elizabeth.plimack@fccc.edu
About this study
Official title: A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer (NEPTUNE)
This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.
Read the detailed description
08JUL2026- Amendment processed updating study title and primary outcome measure to remove the cisplatin eligible requirement as well as updates to the inclusion/exclusion criteria.
- Conditions
- Urothelial Carcinoma
- Being tested
- Enfortumab vedotin, Pembrolizumab
- Keywords
- Neoadjuvant
- 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
Also called PADCEV-EJFV
1.25 mg/kg IV
PembrolizumabDrug
Also called Keytruda
200 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | Enfortumab vedotin 1.25 mg/kg IV on Days 1 and 8 and Pembrolizumab 200 mg IV on Day 1 (every 21 days for 4 cycles)
Definitive surgery (radical nephroureterectomy RNU or distal ureterectomy per treating urologist)
Pembrolizumab 200 mg IV on day 1 (every 21 days for up to 13 cycles) after surgery Receives: Drug: Enfortumab vedotin; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in patients based off pathological response
This trial will estimate the efficacy of combination enfortumab vedotin and pembrolizumab given as neoadjuvant therapy in patients with localized/locally advanced upper tract urothelial cancer (cT2-4 N0-1 M0) followed by definitive surgery. The historic pT0/Ta/Tis/T1 (termed 'response' herein) rate with definitive surgery alone for a comparable patient population (H0) is approximately 20%. This study targets an improvement of 20% in the response proportion to a target 40% response rate (H1) with the combination of enfortumab vedotin and pembrolizumab. Patients who are unable to undergo definitive surgery within 16 weeks from the last dose of neoadjuvant chemotherapy will be considered non-responders for the primary endpoint.
Measured: up to 16 weeks post last neoadjuvant study drug (at time of surgery)
Secondary outcomes (6)
Assess the safety and toxicity of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in UTUC
CTCAE v5 criteria will be used to assess the safety and toxicity of combination enfortumab vedotin and pembrolizumab in eligible UTUC patients. Safety and toxicity will be reported in all patients who receive treatment with any therapy on trial. Toxicity by grade and attribution will be described using counts and proportions.
Measured: up to 30 days after the last dose of study treatment
Assess whether patients who receive the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy have increased surgical complications.
Surgical complications will be assessed by the Clavien-Dindo classification. Grade 1 to Grade 5 (Grade 1 being no deviation and Grade 5 being death).
Measured: up to 12 weeks after surgery
Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring RECIST v1.1 measurable disease.
Overall response in the subset of patients with RECIST v1.1 measurable disease in response evaluable patients with UTUC who receive neoadjuvant combination enfortumab vedotin and pembrolizumab will be measured. The ORR (Overall Response Rate) will be calculated from the partial responses and complete responses in the subset of subjects with have RECIST 1.1 measurable disease at baseline.
Measured: up to 2 years post surgery
Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year recurrence-free survival (RFS).
2-year recurrence-free survival (RFS) proportions and 95% confidence intervals will be estimated using Kaplan-Meier methods.
Measured: up to 2 years post surgery
Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year overall survival (OS).
2-year overall survival (OS) proportions and 95% confidence intervals will be estimated using Kaplan-Meier methods.
Measured: up to 2 years post surgery
Estimate the number of patients who are able to complete neoadjuvant combination enfortumab vedotin and pembrolizumab and safely complete definitive surgery.
Failure to undergo surgery at all or within 16 weeks from the last dose of neoadjuvant therapy. The number of patients and associated proportion who are unable to undergo definitive surgery within 16 weeks from last dose of neoadjuvant therapy or at all will be reported.
Measured: up to 16 weeks post last neoadjuvant study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start22 Jul 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Tsung, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356155
- Sponsor's protocol ID
- UMCC 2023.011
- Acronym
- NEPTUNE
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer (NEPTUNE)
- ClinicalTrials.gov ID
- NCT06356155
- Acronym / sponsor ID
- NEPTUNE / UMCC 2023.011
- Conditions
- Urothelial Carcinoma
- Keywords
- Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.
Detailed description
08JUL2026- Amendment processed updating study title and primary outcome measure to remove the cisplatin eligible requirement as well as updates to the inclusion/exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Drug: Enfortumab vedotin, Drug: PembrolizumabEnfortumab vedotin 1.25 mg/kg IV on Days 1 and 8 and Pembrolizumab 200 mg IV on Day 1 (every 21 days for 4 cycles) Definitive surgery (radical nephroureterectomy RNU or distal ureterectomy per treating urologist) Pembrolizumab 200 mg IV on day 1 (every 21 days for up to 13 cycles) after surgery |
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 a diagnosis of high-grade upper tract (renal pelvis and/or ureter) urothelial carcinoma proven by biopsy or cytology within 60 days prior to registration with the following (cT1-4 N0-1 M0): a. Upper urinary tract mass on cross-sectional imaging or Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology. b. No regional lymph node metastasis, a single regional lymph node metastasis, or multiple regional lymph node metastases (no distant lymph node metastases)
- Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (≥50%) subtype is urothelial carcinoma.
- Patients must be considered to be a candidate for definitive surgery (nephroureterectomy or distal ureterectomy) with curative intent by the treating urologist. Lymph node dissection is strongly encouraged but its scope and determination will be at the discretion of the treating urologist. Details of the surgery such as bladder cuff removal are left to the discretion of the treating urologist. Robotic or open approaches are allowed.
- Prior local endoscopic therapy for upper tract urothelial cancer is permitted if completed at least 6 months prior to the initiation of study treatment and if all toxicities from such therapy have improved to grade 1 or resolved.
- Prior uro-oncologic history: a. History of or active non-invasive carcinoma or carcinoma in situ of the bladder/urethra or upper tract is allowed. b. Patients may have received prior intravesical chemotherapy or immunotherapy such as BCG. c. Prior neoadjuvant or adjuvant chemotherapy or antibody-drug conjugate for bladder cancer or invasive contralateral upper tract cancer is allowed but must have been completed ≥ 1 year prior to study registration.
Key exclusion criteria (21 listed)
- Prior exposure to immune-mediated therapy, including but not limited to, other anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4), anti-PD1, anti-PD-L1, anti-PD-L2 antibodies, and therapeutic anticancer vaccines.
- Prior exposure to monomethyl auristatin E antibody-drug conjugates (MMAE ADC).
- Patient is currently on or used immunosuppressive medication within 14 days prior to the first dose of pembrolizumab. The following are exceptions to this criterion: o Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g., intra-articular injection). o Use of chronic immunosuppressive agents at baseline at doses not to exceed more than prednisone 10 mg/day or equivalent. o Steroids as premedications for hypersensitivity reactions (e.g., CT scan premedication).
- Active or prior documented autoimmune or inflammatory disorders requiring immunosuppressive therapy within 2 years prior to registration. Exceptions are well-controlled hyper/hypothyroidism, celiac disease controlled by diet alone, diabetes mellitus type 1, alopecia, psoriasis, eczema, lichen planus, vitiligo, or similar skin/mucosa conditions.
- Evidence of metastasis (M1) on axial imaging at baseline.
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 vedotinAlso: PADCEV-EJFV1.25 mg/kg IV | Drug | Combination Therapy |
| PembrolizumabAlso: Keytruda200 mg IV | Drug | Combination Therapy |
Primary outcome
Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in patients based off pathological response
Time frame: up to 16 weeks post last neoadjuvant study drug (at time of surgery)
This trial will estimate the efficacy of combination enfortumab vedotin and pembrolizumab given as neoadjuvant therapy in patients with localized/locally advanced upper tract urothelial cancer (cT2-4 N0-1 M0) followed by definitive surgery. The historic pT0/Ta/Tis/T1 (termed 'response' herein) rate with definitive surgery alone for a comparable patient population (H0) is approximately 20%. This study targets an improvement of 20% in the response proportion to a target 40% response rate (H1) with the combination of enfortumab vedotin and pembrolizumab. Patients who are unable to undergo definitive surgery within 16 weeks from the last dose of neoadjuvant chemotherapy will be considered non-responders for the primary endpoint.
6 secondary outcomes
Assess the safety and toxicity of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in UTUC
Time frame: up to 30 days after the last dose of study treatment
Assess whether patients who receive the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy have increased surgical complications.
Time frame: up to 12 weeks after surgery
Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring RECIST v1.1 measurable disease.
Time frame: up to 2 years post surgery
Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year recurrence-free survival (RFS).
Time frame: up to 2 years post surgery
Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year overall survival (OS).
Time frame: up to 2 years post surgery
Estimate the number of patients who are able to complete neoadjuvant combination enfortumab vedotin and pembrolizumab and safely complete definitive surgery.
Time frame: up to 16 weeks post last neoadjuvant study drug
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 16 Jul 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.
Irene Tsung principal investigator
University of Michigan
2 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 Enfortumab vedotin and Pembrolizumab in people with Urothelial Carcinoma, run by University of Michigan Rogel Cancer Center at 2 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 13 inclusion and 21 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in patients based off pathological response (time frame: up to 16 weeks post last neoadjuvant study drug (at time of surgery)). 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 16 Jul 2026.