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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004542-15 | EudraCT Number | ||
| MK-3475-A39 | Other Identifier | Merck | |
| KEYNOTE KN-A39 | Other Identifier | Merck | |
| jRCT2031200284 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) | |
| CTR20220974 | Other Identifier | ChinaDrugTrials.org.cn |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Seagen Inc. | INDUSTRY |
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This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan.
This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in subjects with previously untreated locally advanced or metastatic urothelial cancer.
Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol defined reason for study discontinuation occurs. Pembrolizumab may be administered for a maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Enfortumab vedotin + pembrolizumab |
|
| Arm B | Active Comparator | Gemcitabine + cisplatin or carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfortumab vedotin | Drug | Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR) | PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis. | From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months) |
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis. | From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR | ORR as per RECIST v1.1 by BICR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30 percent [%] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. |
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Inclusion Criteria:
Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
Measurable disease by investigator assessment according to RECIST v1.1
Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment
Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of metastatic urothelial carcinoma must be provided for PD-L1 testing prior to randomization
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
Adequate hematologic and organ function
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zejing Wang, MD, PhD | Seagen Inc. | Study Director |
| John Lu, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Research Centers - Chandler | Chandler | Arizona | 85224 | United States | ||
| Arizona Oncology Associates PD - HOPE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41925239 | Derived | Gupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Homet Moreno B, Beaumont JL, Purnajo I, McManus S, Powles T. How enfortumab vedotin plus pembrolizumab affects the quality of life of people with advanced urothelial cancer compared with platinum-based chemotherapy: a plain language summary of patient-reported outcomes from the EV-302 study. Future Oncol. 2026 Apr;22(9):1015-1029. doi: 10.1080/14796694.2026.2645984. Epub 2026 Apr 2. | |
| 41563650 |
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Results are reported only for primary outcome measures at primary completion date (08-Aug-2023). Remaining secondary outcome measures whose analysis are not final, results would be reported at study completion date.
Participants with untreated locally advanced or metastatic urothelial cancer (UC) were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enfortumab Vedotin + Pembrolizumab | Participants received enfortumab vedotin at 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2023 | Jul 30, 2024 |
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| Pembrolizumab | Drug | IV infusion on Day 1 of every 3-week cycle |
|
|
| Cisplatin | Drug | administered as IV infusion on Day 1 of each 3-week cycle |
|
| Carboplatin | Drug | Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle |
|
| Gemcitabine | Drug | IV infusion on Days 1 and 8 of every 3 week cycle |
|
| From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years) |
| Time to Pain Progression (TTPP) | TTPP was defined as the time from the date of randomization to date of pain progression. Pain progression was defined as a participant reporting either of the following, whichever came first: 1) Increase of 2 or more points from baseline on Brief Pain Inventory - Short Form (BPI-SF) Question 3 (i.e., pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels) maintained for at least two consecutive assessments. 2) Initiation of new opioid medication from baseline for pain with usage maintained for at least two consecutive assessments as recorded in BPI-SF Question 7 (i.e., What medications received for pain). | From the date of randomization to date of pain progression (maximum up to approximately 7.4 years) |
| Change From Baseline in Worst Pain Using BPI-SF at Week 26 | Brief Pain Inventory (BPI-SF) was defined as summary of the worst, least, and average pain experienced in the last 24 hours as well as pain right now and number of pain locations were provided for each treatment arm. BPI-sf worst pain measured the severity of pain based on the pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels. | Baseline, Week 26 |
| PFS Per RECIST v1.1 by Investigator Assessment | PFS as per RECIST v1.1 by investigator was defined as the time from date of randomization to first documentation of PD, or to death due to any cause, whichever comes first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. | From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 7.4 years) |
| ORR Per RECIST v1.1 by Investigator Assessment | ORR as per RECIST v1.1 by investigator was defined as the percentage of participants with confirmed CR or PR. CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. | From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years) |
| Duration of Response (DOR) Per RECIST v1.1 by BICR | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per BICR or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years) |
| DOR Per RECIST v1.1 by Investigator Assessment | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. | From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years) |
| Disease Control Rate (DCR) Per RECIST v1.1 by BICR | DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (>30% shrinkage) nor progression (>20% growth). | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years) |
| DCR Per RECIST v1.1 by Investigator Assessment | DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (>30% shrinkage) nor progression (>20% growth). | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years) |
| Mean Scores in Patient Reported Outcome (PRO) Assessment Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) | The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). | End of study (approximately up to 7.4 years) |
| Change From Baseline in PRO Assessment Measured by the EQ-5D-5L | The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). | Baseline, End of study (approximately up to 7.4 years) |
| Mean Scores in PRO Assessment Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. | End of study (approximately up to 7.4 years) |
| Change From Baseline in PRO Assessment Measured by EORTC QLQ-C30 | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. | Baseline, End of study (approximately up to 7.4 years) |
| Number of Participants With Treatment Emergent Adverse Events Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) |
| Number of Participants With Serious TEAE | SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) |
| Number of Participants With Grade 3-5 TEAE | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per common terminology criteria for adverse events (CTCAE) version 4, Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) |
| Number of Participants Related to Treatment AEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment relatedness was assessed by the investigator. | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) |
| Number of Participants With Laboratory Abnormalities | Laboratory abnormalities included Hematology and Serum Chemistry. In Hematology (increased : hemoglobin, lymphocytes, leukocytes, and decreased : hemoglobin, lymphocytes, neutrophils, platelets and leukocytes) and In serum chemistry (increased in : alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, creatinine, glucose (non-fasting), potassium, sodium, and decreased in albumin, calcium corrected for albumin, glucose (non-fasting), potassium, phosphate and sodium). | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) |
| Number of Participants With Treatment Discontinuation Rate Due to AEs | During study (approximately up to 7.4 years) |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Providence St Joseph Medical Center | Burbank | California | 91505 | United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| University of California Los Angeles Medical Center | Los Angeles | California | 90095 | United States |
| University of California Irvine - Newport | Orange | California | 92868 | United States |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | United States |
| University of Colorado Hospital / University of Colorado | Aurora | Colorado | 80045 | United States |
| Cancer Centers of Colorado - Denver | Denver | Colorado | 80218 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States |
| Eastern CT Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Lombardi Cancer Center / Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Georgia Cancer Specialists / Northside Hospital Cancer Institute | Marietta | Georgia | 30060 | United States |
| Louisiana State University/ East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| Maine Health Cancer Care | Biddeford | Maine | 04046 | United States |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21231 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | United States |
| New York University (NYU) Cancer Institute | New York | New York | 10016 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | United States |
| Hillman Cancer Center / University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Saint Francis Hospital / Bon Secours - South Carolina | Greenville | South Carolina | 29607 | United States |
| West Cancer Center & Research Institute | Germantown | Tennessee | 38138 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| UT Health East Texas Hope Cancer Center | Tyler | Texas | 75701 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | 98109 | United States |
| Site AR54008 | Buenos Aire | C1019ABS | Argentina |
| Site AR54011 | CABA | C1426ANZ | Argentina |
| Site AR54005 | Córdoba | X5004FHP | Argentina |
| Site AR54006 | La Rioja | 5300 | Argentina |
| Site AR54004 | Mendoza | M5500AYB | Argentina |
| Site AR54001 | Rosario | 2000 | Argentina |
| Site AR54002 | San Miguel | T400GTB | Argentina |
| Site AR54012 | San Miguel de Tucumán | T4000IAK | Argentina |
| Site AR54003 | Viedma | 8500 | Argentina |
| Site AU61003 | Box Hill | 3128 | Australia |
| Site AUS61001 | Douglas | 4814 | Australia |
| Site AUS61004 | Heidelberg | 3084 | Australia |
| Site AUS61002 | Macquarie Park | 2109 | Australia |
| Site AUS61006 | South Australia | 5112 | Australia |
| Site AU61005 | South Brisbane | 4101 | Australia |
| Site BE32003 | Brussels | 1200 | Belgium |
| Site BE32002 | Ghent | 9000 | Belgium |
| Site BE32001 | Liège | 4000 | Belgium |
| Site BE32007 | Lueven | 3000 | Belgium |
| Site BE32006 | Roeselare | 8800 | Belgium |
| Site CA11004 | Calgary | Alberta | T2N 4N2 | Canada |
| Site CA11003 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Site CA11006 | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Site CA11002 | Hamilton | Ontario | L8V 1C3 | Canada |
| Site CA11009 | London | Ontario | N6A 5A5 | Canada |
| Site CA11011 | Oshawa | Ontario | L1G 2B9 | Canada |
| Site CA11012 | Toronto | Ontario | M4N 3M5 | Canada |
| Site CA11005 | Toronto | Ontario | M5G 2M9 | Canada |
| Site CA11010 | Montreal | Quebec | H2X 0A9 | Canada |
| Site CA11001 | Montreal | Quebec | H3T 1E2 | Canada |
| Site CA11008 | Québec | G1R 2J6 | Canada |
| Site CN86009 | Beijing | 100021 | China |
| Site CN86001 | Beijing | 100036 | China |
| Site CN86004 | Beijing | 100050 | China |
| Site CN86005 | Beijing | 100191 | China |
| Site CN86015 | Bengbu | 233000 | China |
| Site CN86003 | Changchun | 130021 | China |
| Site CN86006 | Changsha | 410013 | China |
| Site CN86016 | Changsha | 410013 | China |
| Site CN86010 | Chengdu | 610041 | China |
| Site CN86024 | Chongqing | 400030 | China |
| Site CN86007 | Chongqing | 400038 | China |
| Site CN86028 | Fuzhou | 350005 | China |
| Site CN86002 | Guangzhou | 510120 | China |
| Site CN86020 | Gunagzhou | 510280 | China |
| Site CN86018 | Hangzhou | 0571 | China |
| Site CN86013 | Hangzhou | 310014 | China |
| Site CN86022 | Hangzhou | 310016 | China |
| Site CN86025 | Hefei | 400030 | China |
| Site CN86027 | Jinan | 250021 | China |
| Site CN86017 | Nanjing | 210008 | China |
| Site CN86012 | Nanjing | 210029 | China |
| Site CN86021 | Ningbo | 315016 | China |
| Site CN86014 | Shanghai | 200040 | China |
| Site CN86011 | Shenyang | 110022 | China |
| Site CN86023 | Tianjin | 300052 | China |
| Site CN86019 | Tianjin | 453000 | China |
| Site CN86029 | Wenzhou | 325000 | China |
| Site CN86008 | Wuhan | 430030 | China |
| Site CN86030 | Xicheng District | 100034 | China |
| Site CN86026 | Xuzhou | 221009 | China |
| Site CZ42006 | Brno | 656 91 | Czechia |
| Site CZ42001 | Hradec Králové | 500 05 | Czechia |
| Site CZ42004 | Olomouc | 779 00 | Czechia |
| Site CZ42005 | Praha 4-Krc | 140 59 | Czechia |
| Site DK45001 | Aalborg | 9100 | Denmark |
| Site DK45003 | Aarhus N | 8200 | Denmark |
| Site FR33014 | Bordeaux | 33000 | France |
| Site FR33016 | Lyon | 69373 | France |
| Site FR33003 | Nice | 06189 | France |
| Site FR33020 | Pierre-Bénite | 69495 | France |
| Site FR33013 | Strasbourg | 67200 | France |
| Site FR33017 | Tours | 37044 | France |
| Site FR33011 | Villejuif-Cedex-France | 94805 | France |
| Site DE49003 | Berlin | 10117 | Germany |
| Site DE49013 | Bielefeld | 33611 | Germany |
| Site DE49016 | Düsseldorf | 40225 | Germany |
| Site DE49014 | Erlangen | 91054 | Germany |
| Site DE49011 | Essen | 45147 | Germany |
| Site DE49007 | Frankfurt am Main | 60488 | Germany |
| Site DE49015 | Göttingen | 37099 | Germany |
| Site DE49005 | Heidelberg | 69120 | Germany |
| Site DE49009 | Herne | 44649 | Germany |
| Site DE49006 | Jena | 07747 | Germany |
| Site DE49001 | Lübeck | 23538 | Germany |
| Site DE49008 | Magdeburg | 39120 | Germany |
| Site DE49012 | Mannheim | 68167 | Germany |
| Site DE49002 | München | 81675 | Germany |
| Site DE49004 | Tübingen | 72076 | Germany |
| Site DE49010 | Ulm | 89081 | Germany |
| Site HU36003 | Budapest | 1083 | Hungary |
| Site HU36002 | Budapest | 1122 | Hungary |
| Site HU36006 | Debrecen | 4032 | Hungary |
| Site HU36001 | Nyíregyháza | 4400 | Hungary |
| Site HU36005 | Szolnok | 5004 | Hungary |
| Site IL97203 | Beersheba | 84101 | Israel |
| Site IL97201 | Haifa | 31096 | Israel |
| Site IL97209 | Holon | 58100 | Israel |
| Site IL97206 | Jerusalem | 91120 | Israel |
| Site IL97202 | Kfar Saba | 44281 | Israel |
| Site IL97208 | Petah Tikva | 49414 | Israel |
| Site IL97211 | Rehovot | 76100 | Israel |
| Site IL97210 | Tel Aviv | 64239 | Israel |
| Site IL97204 | Tel Litwinsky | 52621 | Israel |
| Site IL97205 | Ẕerifin | 70300 | Israel |
| Site IT39005 | Areezo | 52100 | Italy |
| Site IT39008 | Candiolo | 10060 | Italy |
| Site IT39009 | Cremona | 26100 | Italy |
| Site IT39006 | Genova | 16132 | Italy |
| Site IT39003 | Meldola | 47014 | Italy |
| Site IT39014 | Milan | 20132 | Italy |
| Site IT39007 | Milan | 20141 | Italy |
| Site IT39004 | Pisa | 56126 | Italy |
| Site IT39002 | Terni | 05100 | Italy |
| Site IT39011 | Torrette | 60126 | Italy |
| Site IT39001 | Verona | 37134 | Italy |
| Site JP81002 | Bunkyō City | Japan |
| Site JP81009 | Chiba | Japan |
| Site JP81018 | Chiba | Japan |
| Site JP81013 | Fukuoka | Japan |
| Site JP81020 | Fukuoka | Japan |
| Site JP81011 | Hirosaki | Japan |
| Site JP81006 | Kawasaki-shi | Japan |
| Site JP81001 | Kōtoku | Japan |
| Site JP81017 | Kyoto | Japan |
| Site JP81015 | Niigata | Japan |
| Site JP81005 | Okayama | Japan |
| Site JP81008 | Osaka | Japan |
| Site JP81016 | Osakasayama-Shi | Japan |
| Site JP81007 | Sapporo | Japan |
| Site JP81012 | Sendai | Japan |
| Site JP81014 | Tokushima | Japan |
| Site JP81019 | Tokyo | Japan |
| Site JP81003 | Toyama | Japan |
| Site JP81004 | Tsukuba | Japan |
| Site JP81010 | Ube | Japan |
| Site NL31002 | Amsterdam | 1066 CX | Netherlands |
| Site NL31001 | Amsterdam | 1081 HV | Netherlands |
| Site NL31005 | Amsterdam, Noord-Holland | 1066 CX | Netherlands |
| Site NL31007 | Leeuwarden | 8934 AD | Netherlands |
| Site NL31004 | Nieuwegein | 3435 CM | Netherlands |
| Site NL31003 | Rotterdam | 3075 EA | Netherlands |
| Site NL31006 | Utrecht | 3584 CX | Netherlands |
| Site PL48002 | Warsaw | 01-748 | Poland |
| Site RU70016 | Arkhangelsk | 163045 | Russia |
| Site RU70013 | Barnaul | 656049 | Russia |
| Site RU70020 | Ivanovo | 153040 | Russia |
| Site RU70014 | Krasnoyarsk | 660133 | Russia |
| Site RU70006 | Leningradskaya Oblast' | 188663 | Russia |
| Site RU70004 | Moscow | 105077 | Russia |
| Site RU70011 | Moscow | 123056 | Russia |
| Site RU70003 | Moscow | 125284 | Russia |
| Site RU70017 | Nizhny Novgorod | 603074 | Russia |
| Site RU70002 | Omsk | 644013 | Russia |
| Site RU70019 | Pyatigorsk | 357502 | Russia |
| Site RU70010 | Saint Petersburg | 195271 | Russia |
| Site RU70007 | Saint Petersburg | 197082 | Russia |
| Site RU70008 | Saint Petersburg | 197758 | Russia |
| Site RU70012 | Saint Petersburg | 197758 | Russia |
| Site RU70009 | Saransk | 430032 | Russia |
| Site RU70015 | Tyumen | 625041 | Russia |
| Site RU70005 | Ufa | 450000 | Russia |
| Site SG65001 | Singapore | 119074 | Singapore |
| Site SG65002 | Singapore | 169610 | Singapore |
| Site SG65003 | Singapore | 308433 | Singapore |
| Site KR82001 | Daejeon | 301-721 | South Korea |
| Site KR82002 | Goyang-si | 10408 | South Korea |
| Site KR82008 | Hwasun | 519-763 | South Korea |
| Site KR82004 | Seongnam-si | 13605 | South Korea |
| Site KR82003 | Seoul | 03722 | South Korea |
| Site KR82005 | Seoul | 05505 | South Korea |
| Site KR82007 | Seoul | 135-710 | South Korea |
| Site KR82006 | Seoul | 137-701 | South Korea |
| Site ES34017 | Barcelona | 08003 | Spain |
| Site ES34010 | Barcelona | 08035 | Spain |
| Site ES34006 | Barcelona | 08036 | Spain |
| Site ES34001 | Barcelona | 08041 | Spain |
| Site ES34008 | Barcelona | 08907 | Spain |
| Site ES34013 | Córdoba | 14004 | Spain |
| Site ES34021 | Lugo | 27003 | Spain |
| Site ES34018 | Madrid | 28007 | Spain |
| Site ES34002 | Madrid | 28034 | Spain |
| Site ES34003 | Madrid | 28040 | Spain |
| Site ES34015 | Madrid | 28041 | Spain |
| Site ES34004 | Manresa | 08243 | Spain |
| Site ES34020 | Pamplona | 31008 | Spain |
| Site ES34016 | Sabadell | 08208 | Spain |
| Site ES34012 | Santander | 39008 | Spain |
| Site ES34007 | Seville | 41013 | Spain |
| Site ES34019 | Valencia | 46009 | Spain |
| Site ES34009 | Valencia | 46014 | Spain |
| Site CH41004 | Basel | 4031 | Switzerland |
| Site CH41002 | Bern | 3010 | Switzerland |
| Site CH41001 | Chur | 7000 | Switzerland |
| Site CH41003 | Winterthur | 8401 | Switzerland |
| Site TW88603 | Kaohsiung City | 83301 | Taiwan |
| Site TW88602 | Kweishan | 333 | Taiwan |
| Site TW88607 | Taichung | 40447 | Taiwan |
| Site TW88606 | Taichung | 40705 | Taiwan |
| Site TW88604 | Tainan | 70403 | Taiwan |
| Site TW88605 | Taipei | 10002 | Taiwan |
| Site TW88601 | Taipei | 11217 | Taiwan |
| Site TH66004 | Bangkok | 10330 | Thailand |
| Site TH66003 | Bangkok | 10400 | Thailand |
| Site TH66006 | Bangkok | 10700 | Thailand |
| Site TH66005 | Chiang Mai | 50200 | Thailand |
| Site TH66002 | Hat Yai | 90110 | Thailand |
| Site TH66007 | Muang | 40002 | Thailand |
| Site TH66001 | Ratchathewi | 10400 | Thailand |
| Site TR90007 | Ankara | 6100 | Turkey (Türkiye) |
| Site TR90009 | Ankara | 6230 | Turkey (Türkiye) |
| Site TR90005 | Antalya | 07059 | Turkey (Türkiye) |
| Site TR90004 | Edirne | 22030 | Turkey (Türkiye) |
| Site TR90008 | Istanbul | 34093 | Turkey (Türkiye) |
| Site TR90003 | Istanbul | 34214 | Turkey (Türkiye) |
| Site TR90002 | Istanbul | 81450 | Turkey (Türkiye) |
| Site TR90001 | Konya | 42080 | Turkey (Türkiye) |
| Site TR90006 | Malatya | 44280 | Turkey (Türkiye) |
| Site UK44005 | Glasgow | G12 0YN | United Kingdom |
| Site UK44001 | London | EC1M 6BQ | United Kingdom |
| Site UK44009 | London | W6 8RF | United Kingdom |
| Site UK44006 | Oxford | OX3 7LE | United Kingdom |
| Site UK44010 | Plymouth | PL6 8DH | United Kingdom |
| Site UK44002 | Preston | PR2 9HT | United Kingdom |
| Site UK44003 | Sheffield | S10 2RX | United Kingdom |
| Site UK44008 | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Kikuchi E, Van der Heijden MS, Valderrama BP, Gupta S, Bedke J, Shin SJ, Li JR, Guo J, Danchaivijitr P, Kanesvaran R, Park SH, Su WP, Kandori S, Bae WK, Wong A, Gorla S, Bavle A, Yu X, Lu YT, Powles T. Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma. Int J Clin Oncol. 2026 Mar;31(3):436-446. doi: 10.1007/s10147-025-02950-8. Epub 2026 Jan 21. |
| 41039930 | Derived | Meng Y, Zhang S, Aout M, Babcock A, Li H, Lai Y, Brand-Wiita S, Notinger S, Bavle A, Mamtani R. Cost-effectiveness of enfortumab vedotin plus pembrolizumab as a first-line treatment of locally advanced or metastatic urothelial carcinoma in the United States. J Med Econ. 2025 Dec;28(1):1779-1797. doi: 10.1080/13696998.2025.2567190. Epub 2025 Oct 14. |
| 40449498 | Derived | Gupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Moreno BH, Beaumont JL, Purnajo I, McManus S, Powles T. Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2025 Jun;26(6):795-805. doi: 10.1016/S1470-2045(25)00158-5. |
| 38446680 | Derived | Niegisch G. Enfortumab Vedotin and Pembrolizumab - A New Perspective on Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):944-946. doi: 10.1056/NEJMe2400311. No abstract available. |
| 38446675 | Derived | Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, Castellano D, Fornarini G, Li JR, Gumus M, Mar N, Loriot Y, Flechon A, Duran I, Drakaki A, Narayanan S, Yu X, Gorla S, Homet Moreno B, van der Heijden MS; EV-302 Trial Investigators. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):875-888. doi: 10.1056/NEJMoa2312117. |
| 36041086 | Derived | Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30. |
| FG001 | Standard of Care | Participants received gemcitabine at 1000 mg/m^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m^2) or carboplatin (area under curve [AUC] 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) analysis set include all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enfortumab Vedotin + Pembrolizumab | Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks. |
| BG001 | Standard of Care | Participants received gemcitabine at 1000 mg/m^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR) | PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis. | ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months) |
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| Primary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis. | ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months) |
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| Secondary | Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR | ORR as per RECIST v1.1 by BICR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30 percent [%] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. | Not Posted | Sep 2027 | From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Pain Progression (TTPP) | TTPP was defined as the time from the date of randomization to date of pain progression. Pain progression was defined as a participant reporting either of the following, whichever came first: 1) Increase of 2 or more points from baseline on Brief Pain Inventory - Short Form (BPI-SF) Question 3 (i.e., pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels) maintained for at least two consecutive assessments. 2) Initiation of new opioid medication from baseline for pain with usage maintained for at least two consecutive assessments as recorded in BPI-SF Question 7 (i.e., What medications received for pain). | Not Posted | Sep 2027 | From the date of randomization to date of pain progression (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Worst Pain Using BPI-SF at Week 26 | Brief Pain Inventory (BPI-SF) was defined as summary of the worst, least, and average pain experienced in the last 24 hours as well as pain right now and number of pain locations were provided for each treatment arm. BPI-sf worst pain measured the severity of pain based on the pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels. | Not Posted | Sep 2027 | Baseline, Week 26 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Per RECIST v1.1 by Investigator Assessment | PFS as per RECIST v1.1 by investigator was defined as the time from date of randomization to first documentation of PD, or to death due to any cause, whichever comes first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. | Not Posted | Sep 2027 | From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR Per RECIST v1.1 by Investigator Assessment | ORR as per RECIST v1.1 by investigator was defined as the percentage of participants with confirmed CR or PR. CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. | Not Posted | Sep 2027 | From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST v1.1 by BICR | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per BICR or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Not Posted | Sep 2027 | From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR Per RECIST v1.1 by Investigator Assessment | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. | Not Posted | Sep 2027 | From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Per RECIST v1.1 by BICR | DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (>30% shrinkage) nor progression (>20% growth). | Not Posted | Sep 2027 | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DCR Per RECIST v1.1 by Investigator Assessment | DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (>30% shrinkage) nor progression (>20% growth). | Not Posted | Sep 2027 | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Scores in Patient Reported Outcome (PRO) Assessment Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) | The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). | Not Posted | Sep 2027 | End of study (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in PRO Assessment Measured by the EQ-5D-5L | The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). | Not Posted | Sep 2027 | Baseline, End of study (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Scores in PRO Assessment Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. | Not Posted | Sep 2027 | End of study (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in PRO Assessment Measured by EORTC QLQ-C30 | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. | Not Posted | Sep 2027 | Baseline, End of study (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Not Posted | Sep 2027 | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious TEAE | SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Not Posted | Sep 2027 | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3-5 TEAE | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per common terminology criteria for adverse events (CTCAE) version 4, Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. | Not Posted | Sep 2027 | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Related to Treatment AEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment relatedness was assessed by the investigator. | Not Posted | Sep 2027 | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities | Laboratory abnormalities included Hematology and Serum Chemistry. In Hematology (increased : hemoglobin, lymphocytes, leukocytes, and decreased : hemoglobin, lymphocytes, neutrophils, platelets and leukocytes) and In serum chemistry (increased in : alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, creatinine, glucose (non-fasting), potassium, sodium, and decreased in albumin, calcium corrected for albumin, glucose (non-fasting), potassium, phosphate and sodium). | Not Posted | Sep 2027 | From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Discontinuation Rate Due to AEs | Not Posted | Sep 2027 | During study (approximately up to 7.4 years) | Participants |
From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enfortumab Vedotin + Pembrolizumab | Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks. | 133 | 442 | 220 | 440 | 435 | 440 |
| EG001 | Standard of Care | Participants received gemcitabine at 1000 mg/m^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks. | 226 | 444 | 169 | 433 | 418 | 433 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute right ventricular failure | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Large intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Malignant gastrointestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rectal ulcer haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract stoma complication | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diabetic hyperglycaemic coma | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune-mediated neuropathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Postrenal failure | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urinoma | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pharyngeal dyskinesia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute generalised exanthematous pustulosis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| SJS-TEN overlap | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Toxic erythema of chemotherapy | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seagen Inc. | (855) 473-2436 | medinfo@seagen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2023 | Jul 30, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000632577 | enfortumab vedotin |
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Multiple |
|
| Unknown |
|
| Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|