A Phase 1/2 interventional study of enfortumab vedotin (EV) and pembrolizumab in Carcinoma, Transitional Cell, Urinary Bladder Neoplasms and Urologic Neoplasms, sponsored by Astellas Pharma Global Development, Inc.. Terminated at 106 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Astellas Pharma Global Development, Inc. (part of Astellas Pharma Inc) · Phase 1/2, Interventional, and Treatment
This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.
This study will examine the safety and anticancer activity of enfortumab vedotin (EV) given intravenously as monotherapy and in combination with other anticancer therapies as first line (1L) and second line (2L) treatment for patients with urothelial cancer. The primary goal of the study is to determine the safety, tolerability, and efficacy of enfortumab vedotin alone and in combination with pembrolizumab and/or chemotherapy. The study will be conducted in multiple parts:
Locally advanced or metastatic urothelial cancer:
Expansion
Randomized Cohort K
Muscle invasive bladder cancer:
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.
This study's enrollment of 348 is above the median of 50 across 500 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Astellas Pharma Global Development, Inc. is the lead sponsor of 207 studies on the registry; 23 are open to participants now.
Of its 82 completed or terminated interventional studies of FDA-regulated products, 38 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Locally advanced or urothelial cancer (la/mUC) - Cohorts A, B, D, E, F, G and K.
Muscle Invasive Bladder Cancer (MIBC)- Cohorts H, J and L.
Exclusion Criteria:
la/mUC - Cohorts A, B, D, E, F, G, and K
MIBC - Cohorts H, J, and L
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: pembrolizumab
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: pembrolizumab
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: pembrolizumab
Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: cisplatin
Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: carboplatin
Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days
Drug: enfortumab vedotin (EV) · Drug: gemcitabine
Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: pembrolizumab · Drug: cisplatin · Drug: carboplatin
Enfortumab vedotin on days 1 and 8 every 21 days
Drug: enfortumab vedotin (EV)
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: pembrolizumab
Enfortumab vedotin on days 1 and 8 every 21 days
Drug: enfortumab vedotin (EV)
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV) · Drug: pembrolizumab
Enfortumab vedotin on days 1 and 8 and every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Also known as: ASG-22CE, ASG-22ME, PADCEV
IV infusion on day 1 every 21 days
Also known as: Keytruda
IV infusion on day 1 every 21 days
IV infusion on day 1 every 21 days
IV infusion on days 1 and 8 every 21 days
Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only)
Descriptive statistics will be used to summarize results.
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.
Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)
Descriptive statistics will be used to summarize results.
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)
The proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1
Time frame: Up to 3 years
Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)
The proportion of patients with absence of viable tumor tissue at the time of radical cystectomy.
Time frame: Up to approximately 5 months
Incidence of dose-limiting toxicity (DLT)
Incidence of DLTs (dose-escalation expansion Cohorts D, E, F, and the first 6 patients of Cohort G).
Time frame: 21 days
Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
The proportion of patients with confirmed CR or PR according to RECIST 1.1.
Time frame: Up to 3 years
Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Cohort A only)
The proportion of patients with confirmed CR or PR according to RECIST 1.1
Time frame: Up to 3 years
Confirmed ORR by investigator assessment per the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
The proportion of patients with confirmed CR or PR according to iRECIST.
Time frame: Up to 3 years
Disease control rate (DCR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1.
Time frame: Up to 5 years
DCR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1
Time frame: Up to 3 years
DCR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts using pembrolizumab only)
Proportion of patients with CR, PR, or SD according to iRECIST.
Time frame: Up to 3 years
Duration of response (DOR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD per RECIST 1.1) or to death due to any cause, whichever comes first.
Time frame: Up to 5 years
DOR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per RECIST 1.1 or to death due to any cause, whichever comes first
Time frame: Up to 5 years
DOR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per iRECIST or to death due to any cause, whichever comes first.
Time frame: Up to 5 years
Progression free survival on study therapy (PFS) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first.
Time frame: Up to 5 years
PFS by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first
Time frame: Up to 5 years
PFS by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
The time from start of study treatment to first documentation of objective tumor progression (PD per iRECIST) on or following study therapy, or to death due to any cause, whichever comes first.
Time frame: Up to 5 years
Event-free (EFS) on study therapy by BICR (Cohort L only)
The time from the start of study treatment to the first occurrence of any of the following events: (1) Radiographic disease progression precluding a curative intent surgery as assessed by BICR prior to RC+PLND. (2) Failure to undergo RC+PLND for participants with residual muscle-invasive disease and/or any radiographic disease present. (3) Gross residual disease left behind at time of RC+PLND. (4) Local or distant recurrence post-RC as assessed by CT or MRI and/or biopsy. (5) Death from any cause.
Time frame: Up to 3 years
Event-free (EFS) on study therapy by investigator assessment (MIBC cohorts only)
The time from the start of study treatment to the first occurrence of any of the following events: (1) Radiographic disease progression precluding a curative intent surgery as assessed by BICR prior to RC+PLND. (2) Failure to undergo RC+PLND for participants with residual muscle-invasive disease and/or any radiographic disease present. (3) Gross residual disease left behind at time of RC+PLND. (4) Local or distant recurrence post-RC as assessed by CT or MRI and/or biopsy. (5) Death from any cause.
Time frame: Up to 3 years
Overall survival (OS) (all cohorts)
The time from start of study treatment to date of death due to any cause.
Time frame: Up to 5 years
Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Cmax will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
PK parameter for monomethyl auristatin E (MMAE): Cmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Cmax will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
PK parameter for total antibody (Tab): Cmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Cmax will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Blood samples for ATA analysis will be collected.
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.
PK parameter for enfortumab vedotin: Time to maximum concentration (Tmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Tmax will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
PK parameter for MMAE: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Tmax will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
PK parameter for Tab: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Tmax will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
PK parameter for enfortumab vedotin: Area under the concentration-time curve (AUC) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
AUC will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
PK parameter for MMAE: AUC (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
AUC will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
PK parameter for Tab: AUC (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
AUC will be derived from the PK blood samples collected.
Time frame: Through 2 cycles of treatment, up to 42 days
Pathologic downstaging (pDS) rate by central pathology review (MIBC cohorts only)
The pDS rate is defined as patients with tumors \<pT2 and N0 in examined tissue from radical cystectomy (RC) and pelvic lymph node dissection (PLND).
Time frame: Up to approximately 5 months
Disease-free survival (DFS) by investigator assessment (MIBC cohorts only)
DFS is defined as the time from RC to the time of first occurrence of a DFS event, including local recurrence of urothelial cancer (UC), urinary tract recurrence of UC, distant metastasis of UC, or death from any cause.
Time frame: Up to approximately 5 years
DFS by BICR (Cohort L only)
DFS is defined as the time from RC to the time of first occurrence of a DFS event
Time frame: Up to 3 years
Type, incidence, severity, seriousness, and relatedness of AEs (Randomized Cohort K and MIBC cohorts only)
Descriptive statistics will be used to summarize results.
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to approximately 3 years
Type, incidence, and severity of laboratory abnormalities (Randomized Cohort K and MIBC cohorts only)
Descriptive statistics will be used to summarize results.
Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to approximately 3 years
Percentage of planned radical cystectomy and pelvic lymph node dissections (RC+PLND) delayed due to treatment-related AEs (MIBC cohorts only)
Delayed is defined as greater than 12 weeks after the last dose of treatment.
Time frame: Up to approximately 5 months
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Plan to share: Undecided
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enfortumab vedotin
Carcinoma, Transitional Cell →
Astellas Pharma Global Development, Inc. →