An Open-label, Single-Arm, Phase II Study to Evaluate Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Participants With Muscle-invasive Bladder Cancer (EV-209)

Study Identifier:
7465-CL-0209
CT.gov Identifier:
NCT07475806
EudraCT Identifier:
202552448818
EU Trial (CTIS) Number:
2025-524488-18-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

People with a type of bladder cancer called muscle-invasive bladder cancer have cancer that has spread into the muscle wall of the bladder. The standard treatment is to have chemotherapy, followed by surgery to completely remove the bladder. This has a significant impact on people with long-term life-altering changes. There are also limited options for people who cannot have chemotherapy or who do not want their bladder removed.

Studies show that enfortumab vedotin, when given with pembrolizumab, can help people with advanced bladder cancer. This treatment has also worked well for people with muscle-invasive bladder cancer who can't receive chemotherapy when it was given before and after bladder-removal surgery. However, some people can't have or won't have this surgery. There is still a need for new treatments that let people keep their bladder. This is especially important for people who respond well to the enfortumab vedotin, when given with pembrolizumab, and may benefit from continuing this study treatment instead of having surgery.

The main aims of this study are to check how many people continue to respond well to enfortumab vedotin with pembrolizumab and how many people have their bladder intact after 2 years.

People in this study will be adults who have muscle-invasive bladder cancer and are able to have surgery to remove the bladder.

People cannot take part if they have nerve damage (sensory or motor neuropathy), have had certain other cancers, have diabetes that is not under control, or have had a transplant.

People will receive infusions of enfortumab vedotin on the 1st and 8th day of 3-week (21-day) cycles. They will also receive pembrolizumab on the 1st day of every 3-week cycle. There will be safety checks at each visit with checks of the tumors at some visits. The doctors will continue to check for medical problems throughout the study.

People will continue to receive study treatment unless their cancer doesn't improve after 9 cycles of study treatment, or until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away.

People's whose cancer gets worse or doesn't improve after 9 cycles may need bladder surgery, radiotherapy or chemotherapy. People will visit the clinic after they stop their study treatment, in which they will be asked about any medical problems and have a health check. After this, people will continue to have scans every 12 weeks (3 months) for the first 2 years until their cancer gets worse. After this, if their cancer doesn't get worse, they will continue to have scans every 24 weeks (6 months) for up to 5 years to check for any changes in their cancer. After people's cancer gets worse, they won't have any more scans but will have telephone health checks every 3 months.

To evaluate: 1) the overall cCR rate after treatment with enfortumab vedotin in combination with pembrolizumab and 2) the 2-year BI-EFS rate in participants who had cCR.

Primary Objectives: ● To evaluate the overall enfortumab vedotin plus pembrolizumab combination therapy, and the 2-year bidirectional emergency response (BI-EFS) rate in participants achieving cCR. Secondary Objectives: ● To evaluate the overall cCR rate after 4 cycles of enfortumab vedotin plus pembrolizumab combination therapy, and the 2-year bidirectional emergency response (BI-EFS) in participants achieving cCR after 4 cycles. ● To evaluate other efficacy endpoints of enfortumab vedotin plus pembrolizumab combination therapy in participants achieving cCR. ● To evaluate the safety and tolerability of enfortumab vedotin plus pembrolizumab combination therapy.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bladder
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • * Participant has histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0. NOTE: urothelial carcinomas (UCs) not originating from the bladder (e.g., upper tract [ureters, renal pelvis], urethra) are not eligible. UCs invading into the prostatic stroma with no histologic muscle invasion is allowed, provided that the extent of disease is confirmed via imaging. * Participant has predominant UC histology (≥ 50%). NOTE: Participants with mixed histology are eligible provided the urothelial component is ≥ 50% (participants whose tumors contain predominant [≥ 50%] plasmacytoid variant are not eligible). Participants whose tumors contain any neuroendocrine histology are not eligible. * Participant is deemed eligible for radical cystectomy and pelvic lymph node dissection. * Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study intervention. If no archival tumor tissue is available, the participant will have a biopsy to obtain tumor tissue prior to study intervention. * Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Have a transurethral resection of a bladder tumor within 60 days (+14 days) prior to screening (from the date of informed consent form signature).
  • CTIS
  • Participant is ≥ 18 years of age at the time of signing the ICF.
  • Participant has histologically-confirmed MIBC, stage cT2–T4aN0M0 or T1-T4aN1M0.
  • Participant has predominant UC histology (≥ 50%).
  • 4Participant is deemed eligible for RC and PLND by a urologist and/or oncologist.
  • Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study intervention. If no archival tumor tissue is available, the participant will have a biopsy to obtain tumor tissue prior to study intervention.
  • Participant has ECOG performance status of 0 to 2.
  • Have a TUR of a bladder tumor within 60 days (+14 days) prior to screening (from the date of ICF signature).
  • 1. Participant has histologically-confirmed muscle-invasive bladder cancer (MIBC), stage cT2-T4aN0M0 or T1-T4aN1M0.
  • NOTE: urothelial carcinomas (UCs) not originating from the bladder (eg, upper tract [ureters, renal pelvis], urethra) are not eligible. UCs invading into the prostatic stroma with no histologic muscle invasion is allowed, provided that the extent of disease is confirmed via imaging.
  • 2. Participant has predominant UC histology (>/= 50%).
  • NOTE: Participants with mixed histology are eligible provided the urothelial component is >/= 50% (participants whose tumors contain predominant [>/= 50%] plasmacytoid variant are not eligible). Participants whose tumors contain any neuroendocrine histology are not eligible.
  • 3. Participant is deemed eligible for radical cystectomy (RC) and pelvic lymph node dissection (PLND).
  • 4. Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study intervention. If no archival tumor tissue is available, the participant will have a biopsy to obtain tumor tissue prior to study intervention.
  • 5. Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • 6. Have a transurethral resection (TUR) of a bladder tumor within 60 days (+14 days) prior to, or during, screening (from the date of ICF signature).
  • Participants Age be ≥18 years old when signing the ICF.
  • Histologically confirmed MIBC (cT2–T4aN0M0 or T1–T4aN1M0 stage). Note: Urinary tract ulcers not originating from the bladder (e.g., upper urinary tract [ureter, renal pelvis], urethra) are not eligible. Patients with UC that have invaded the prostatic stroma but have not shown histological muscle layer infiltration are permitted to be included after the extent of the lesion has been confirmed by imaging.
  • The primary histological type was UC (≥50%). Note: Participants with mixed bladder cancer who had urothelial components ≥50% were eligible for Inclusion criteria(participants whose tumors were predominantly composed of plasmacytoid variant cells [≥50%] were ineligible for Inclusion criteria). Subjects with any neuroendocrine histological components in their tumor tissue were ineligible for Inclusion criteria.
  • The urologist and/or oncologist deemed the participant suitable for receiving RC and PLND.
  • Participants have archived tumor tissue obtained from the primary tumor site, the source and availability of which have been confirmed prior to study treatment. If no archived tumor tissue is available, a biopsy will be performed on the participant prior to study treatment to obtain tumor tissue.
  • Participants' ECOG fitness scores ranged from 0 to 2.
  • Participants' baseline laboratory data must meet the following requirements. If a participant has recently received a transfusion, hematological examinations must be performed ≥14 days after any transfusion. ● ANC ≥1.5 × 10⁹/L ● Platelet count ≥100 × 10⁹/L ● Hemoglobin ≥9 g/dL ● GFR ≥30 mL/min, estimated according to the Cockcroft-Gault criteria or measured via 24-hour urine collection ● Serum TBL ≤1.5 × ULN or ≤3 × ULN (for participants with Gilbert's syndrome) ● ALT and AST ≤2.5 × ULN ● INR or both PT and aPTT ≤1.5 × ULN; if the participant is receiving anticoagulation therapy, PT or aPTT must be within the expected therapeutic range of the anticoagulant. PTT may be used if aPTT cannot be tested at the local laboratory.
  • Female participants: ● Not pregnant and meeting at least one of the following criteria: a. Not WOCBP; b. WOCBP with a negative urine or serum pregnancy test result at screening or within 7 days prior to Day 1, and agreeing to follow contraceptive guidelines from the date of signing the informed consent form until at least 6 months after the last dose of study treatment. ● Not breastfeeding or nursing throughout the study period from the date of screening and for at least 6 months after the last dose of study treatment. ● Not donating eggs throughout the study period from the first dose of study treatment and for 6 months after the last dose of study treatment.
  • Male participants: ● Must agree to use contraception with a female partner of reproductive age (including breastfeeding partners) throughout the treatment period and for 4 months after the last dose of study treatment. ● If the partner is pregnant, must agree to abstain from sex or use condoms throughout the pregnancy, both during the study period and for 4 months after the last dose of study treatment. ● Must not donate sperm during the treatment period and for 4 months after the last dose of study treatment.
  • Participants have provided informed consent, including consent to comply with the requirements and restrictions listed in the ICF and the program.
  • Receive bladder tumor TUR within 60 days (+14 days) prior to screening (from the date of signing ICF).
  • Participants agreed not to participate in other interventional studies during the period of study treatment.
Exclusion criteria
  • Participant has preexisting sensory or motor neuropathy Grade ≥ 2. * Participant has ≥ N2 disease or metastatic disease (M1) as identified by imaging * Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7% and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. The lowest HbA1c during the screening period will be used to determine eligibility. * Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed. * Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated. * Participant has a history of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. * Participant has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. * Participant 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 the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency. * Participant has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Brief (< 7 days) use of systemic corticosteroids is allowed when use is considered standard of care. * Participant with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded. * Participant requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded. * Participant with hypothyroidism that is stable with hormone replacement therapy or Sjögren's syndrome will not be excluded. * Participant has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). * Participant has received prior systemic anti-cancer therapy for MIBC/non-muscle invasive bladder cancer (NMIBC), or received prior systemic anti-cancer therapy including investigational agents (including enfortumab vedotin or other monomethyl auristatin E-based antibody-drug conjugates) within 3 years prior to screening. NOTE: Prior treatment for NMIBC with intravesical instillation therapy such as Bacillus Calmette-Guérin or intravesical chemotherapy is permitted. Prior systemic treatment (including, but not limited to, anti-PD-1/PD-L1 treatment with pembrolizumab, etc.) received for NMIBC is not permitted. * Participant has received a partial cystectomy of the bladder to remove any NMIBC or MIBC. * Participant has received any prior radiotherapy to the bladder.
  • CTIS
  • Participant has preexisting sensory or motor neuropathy Grade ≥ 2
  • Participant 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 coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
  • Participant has received prior systemic anti-cancer therapy for MIBC/NMIBC, or received prior systemic anti-cancer therapy including investigational agents (including enfortumab vedotin or other MMAE-based ADCs) within 3 years prior to screening
  • Participant has received a partial cystectomy of the bladder to remove any NMIBC or MIBC.
  • Participant has received any prior radiotherapy to the bladder.
  • Participant has ≥ N2 disease or metastatic disease (M1) as identified by imaging.
  • Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening. Uncontrolled diabetes (within 3 months before first dose) is defined as HbA1c ≥ 8% or HbA1c between 7% and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. The lowest HbA1c during the screening period will be used to determine eligibility.
  • Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
  • Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator
  • Participant has a history of (non-infectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
  • Participant has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Participant 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 the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency."
  • Participant has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • 1. Participant has preexisting sensory or motor neuropathy Grade >/= 2.
  • 2. Participant has >/= N2 disease or metastatic disease (M1) as identified by imaging
  • 3. Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) >/= 8% or HbA1c between 7% and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. The lowest HbA1c during the screening period will be used to determine eligibility.
  • 4. Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
  • 5. Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.
  • 6. Participant has a history of (non-infectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • 7. Participant has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • 8. Participant 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 the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
  • 9. Participant has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • a) Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • b) Brief (< 7 days) use of systemic corticosteroids is allowed when use is considered standard of care.
  • c) Participant with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded.
  • d) Participant requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.
  • e) Participant with hypothyroidism that is stable with hormone replacement therapy or Sjogren's syndrome will not be excluded.
  • 10. Participant has received prior therapy with an anti- programmed cell death protein 1 (PD-1), anti- programmed death-ligand 1 (PD-L1), or anti- programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic t-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137).
  • 11. Participant has received prior systemic anti cancer therapy for MIBC/ non-muscle invasive bladder cancer (NMIBC), or received prior systemic anti cancer therapy including investigational agents (including enfortumab vedotin or other monomethyl auristatin E [MMAE]-based antibody-drug conjugates within 3 years prior to screening.
  • NOTE: Prior treatment for NMIBC with intravesical instillation therapy such as Bacillus Calmette-Guerin or intravesical chemotherapy is permitted. Prior systemic treatment (including, but not limited to, anti-PD-1/PD-L1 treatment with pembrolizumab, etc.) received for NMIBC is not permitted.
  • 12. Participant has received a partial cystectomy of the bladder to remove any NMIBC or MIBC.
  • 13. Participant has received any prior radiotherapy to the bladder. Participants had a history of sensory or motor neuropathy of grade ≥2.
  • Imaging examinations confirmed that participants had ≥N2 disease or metastatic disease (M1).
  • Participants must have a history of uncontrolled diabetes within the 3 months prior to screening. Unless otherwise stated, uncontrolled diabetes (within the 3 months prior to first dose) is defined as HbA1c ≥ 8% or HbA1c in the range of 7% to < 8% accompanied by associated diabetes symptoms (polyuria or polydipsia). Eligibility will be determined using the lowest HbA1c value during the screening period.
  • Participants must have been diagnosed with another malignancy within 3 years prior to the first dose of treatment in the study, or have any evidence of residual disease from a previously diagnosed malignancy. Participants with non-melanoma skin cancer, locally localized prostate cancer that has undergone radical treatment and has no evidence of progression, low-risk or very low-risk (according to standard guidelines) locally localized prostate cancer that is only under active surveillance/observation and has no intention of treatment, or any type of carcinoma in situ (if completely resected) are eligible to participate in this study.
  • Participants had received allogeneic tissue/solid organ transplants.
  • Participants must have active HBV (defined as HBsAg positive and/or anti-HBV core antibody positive) or active HCV (defined as HCV RNA detected [qualitatively]). Participants who are HBsAg positive and/or HBV core antibody positive but have a negative HBV DNA PCR test result may be admitted if they receive appropriate prophylactic antiviral treatment or routine surveillance according to local practice. Participants who have received curative HCV treatment and have demonstrated a sustained virological response for 12 weeks may be admitted to the study. HBV and HCV testing must be performed if mandated by national health regulatory agencies.
  • Participants are known to have a history of HIV infection (HIV 1 or 2). HIV testing is not required unless mandated by local health regulatory authorities.
  • Participants had undergone major surgery within 4 weeks prior to the first dose of the study treatment.
  • Participants had active keratitis or corneal ulcers. Subjects whose superficial punctate keratitis had been adequately treated, as determined by the researchers, were eligible for enrollment.
  • Participants had a history of (non-infectious) lung inflammation/ILD requiring steroid treatment or currently had lung inflammation/ILD.
  • Participants had a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, or idiopathic pneumonia, or their chest CT scan at the time of screening showed evidence of active pneumonia.
  • Participants had an active infection requiring systemic treatment. Participants receiving routine prophylactic antibiotic treatment were eligible to participate in this study.
  • Participants must have a confirmed immunodeficiency or have received prolonged systemic steroid therapy (at a dose exceeding 10 mg prednisone equivalent daily) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Participants with adrenal insufficiency are permitted to use physiological replacement doses of corticosteroids.
  • Participants must have had an active autoimmune disease requiring systemic treatment (i.e., use of disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. ● Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments and are permitted. ● Transient (<7 days) use of systemic corticosteroids is permitted when serving as a SoC. ● Participants with vitiligo, psoriasis, type 1 diabetes, hypothyroidism, or those who have recovered from childhood asthma/specific diseases are not excluded. ● Participants requiring intermittent use of bronchodilators, inhaled steroids, or topical steroid injections are not excluded. ● Participants with stable hypothyroidism or Sjögren's syndrome via HRT are not excluded.
  • Participants had previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drug treatment or drug treatment targeting another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
  • Participants must have received systemic anticancer therapy for MIBC/NMIBC, or prior systemic anticancer therapy, including investigational drugs (such as enfortumab vedotin or other MMAE-containing ADCs), within 3 years prior to screening. Note: Prior bladder instillation therapy (such as BCG) or bladder instillation chemotherapy for NMIBC is permitted. Participants who have previously received systemic therapy for NMIBC (including but not limited to anti-PD-1/PD-L1 therapy drugs such as pembrolizumab) are not eligible to participate in this study.
  • Participants must have received a live or attenuated vaccine within 30 days prior to the first dose of the study treatment. Inactivated vaccines are permitted.
  • Participants had undergone partial cystectomy for NMIBC or MIBC.
  • Participants had previously received any bladder radiation therapy.
  • Participants had received any experimental treatment within 28 days or 5 half-lives (whichever is longer) prior to screening.
  • 20
  • :
  • twenty one Participants had hypersensitivity to enfortumab vedotin or any of the excipients contained in its formulations (including histidine, trehalose dihydrate and polysorbate 20), or to biologics produced using Chinese hamster ovary cells.
  • 21
  • :
  • twenty two Participants had severe hypersensitivity reactions (≥ grade 3) to pembrolizumab and/or any of its excipients.
  • 22
  • :
  • twenty three The researchers believed that some participants were unsuitable for the study.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Bladder