EV-302: Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A Enfortumab vedotin + pembrolizumab |
Drug: Enfortumab vedotin
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
Other Names:
Drug: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle
Other Names:
|
| Active Comparator: Arm B Gemcitabine + cisplatin or carboplatin |
Drug: Cisplatin
administered as IV infusion on Day 1 of each 3-week cycle
Drug: Carboplatin
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
Drug: Gemcitabine
IV infusion on Days 1 and 8 of every 3 week cycle
|
| Experimental: Arm C (Not Recruiting) Enfortumab vedotin + pembrolizumab + Cisplatin or carboplatin |
Drug: Enfortumab vedotin
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
Other Names:
Drug: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle
Other Names:
Drug: Cisplatin
administered as IV infusion on Day 1 of each 3-week cycle
Drug: Carboplatin
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
|
Outcome Measures
Primary Outcome Measures
- Duration of progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR) (Arms A and B only) [Up to approximately 5 years]
Defined as the time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause, whichever comes first.
- Duration of Overall survival (OS) (Arms A and B only) [Up to approximately 5 years]
OS is defined as the time from date of randomization to date of death due to any cause.
Secondary Outcome Measures
- Duration of PFS per RECIST v1.1 by investigator assessment (Arms A and B only) [Up to approximately 5 years]
Defined as the time from randomization to first documentation of disease progression per RECIST v1.1, or to death due to any cause, whichever comes first
- Objective response rate (ORR) per RECIST v1.1 by BICR (Arms A and B only) [Up to approximately 5 years]
Defined as the proportion of subjects with confirmed CR or PR according to RECIST v1.1
- ORR per RECIST v1.1 by investigator assessment (Arms A and B only) [Up to approximately 5 years]
Defined as the proportion of subjects with confirmed CR or PR according to RECIST v1.1
- Duration of response (DOR) per RECIST v1.1 by BICR (Arms A and B only) [Up to approximately 5 years]
Defined as the time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause, whichever comes first
- DOR per RECIST v1.1 by investigator assessment (Arms A and B only) [Up to approximately 5 years]
Defined as the time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause, whichever comes first
- Disease control rate (DCR) per RECIST v1.1 by BICR (Arms A and B only) [Up to approximately 5 years]
Defined as the proportion of subjects with confirmed CR, PR, or SD according to RECIST v1.1
- DCR per RECIST v1.1 by investigator assessment (Arms A and B only) [Up to approximately 5 years]
Defined as the proportion of subjects with confirmed CR, PR, or SD according to RECIST v1.1
- Change from baseline in patient reported outcome assessment measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) [Up to approximately 5 years]
The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale.
- Change from baseline in patient reported outcome assessment measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) [Up to approximately 5 years]
EORTC-QLQ-C30 is a cancer-specific 30-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
- Change from baseline in patient reported outcome assessment measured by Brief Pain Inventory - Short Form (BPI-SF) [Up to approximately 5 years]
The Short Form is a single assessment of overall pain where 0 equals no pain and 10 equals extreme pain. Low pain scores are considered a better outcome than a high pain score.
- Incidence of adverse events (AEs) [Up to approximately 5 years]
Descriptive statistics will be used to summarize results
- Incidence of laboratory abnormalities [Up to approximately 5 years]
Descriptive statistics will be used to summarize results
- Treatment discontinuation rate due to AEs [Up to approximately 5 years]
Descriptive statistics will be used to summarize results
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
-
Measurable disease by investigator assessment according to RECIST v1.1
-
Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy
-
Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
-
Participants that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted
-
Participants that received adjuvant chemotherapy following cystectomy with recurrence >12 months from completion of therapy are permitted
-
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
-
Previously received enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugate (ADCs)
-
Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor for any malignancy, including earlier stage urothelial cancer (UC), defined as a PD-1 inhibitor or PD-L1 inhibitor
-
Received prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor
-
Received anti-cancer treatment with chemotherapy, biologics, or investigational agents not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks prior to first dose of study treatment
-
Uncontrolled diabetes
-
Estimated life expectancy of less than 12 weeks
-
Active central nervous system (CNS) metastases
-
Ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1 or returned to baseline
-
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted.
-
Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
-
History of another invasive malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy
-
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to randomization
-
Receipt of radiotherapy within 2 weeks prior to randomization
-
Received major surgery (defined as requiring general anesthesia and >24 hour inpatient hospitalization) within 4 weeks prior to randomization
-
Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
-
Active keratitis or corneal ulcerations
-
History of autoimmune disease that has required systemic treatment in the past 2 years
-
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
-
Prior allogeneic stem cell or solid organ transplant
-
Received a live attenuated vaccine within 30 days prior to randomization
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ironwood Cancer & Research Centers - Chandler | Chandler | Arizona | United States | 85224 |
| 2 | Arizona Oncology Associates PD - HOPE | Tucson | Arizona | United States | 85710 |
| 3 | Providence St Joseph Medical Center | Burbank | California | United States | 91505 |
| 4 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
| 5 | University of California Los Angeles Medical Center | Los Angeles | California | United States | 90095 |
| 6 | University of California Irvine - Newport | Orange | California | United States | 92868 |
| 7 | Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | United States | 80012 |
| 8 | University of Colorado Hospital / University of Colorado | Aurora | Colorado | United States | 80045 |
| 9 | Cancer Centers of Colorado - Denver | Denver | Colorado | United States | 80218 |
| 10 | Yale Cancer Center | New Haven | Connecticut | United States | 06520 |
| 11 | Eastern CT Hematology and Oncology Associates | Norwich | Connecticut | United States | 06360 |
| 12 | Lombardi Cancer Center / Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 13 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 14 | Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | United States | 30322 |
| 15 | Georgia Cancer Specialists / Northside Hospital Cancer Institute | Marietta | Georgia | United States | 30060 |
| 16 | Louisiana State University/ East Jefferson General Hospital | Metairie | Louisiana | United States | 70006 |
| 17 | Maine Health Cancer Care | Biddeford | Maine | United States | 04046 |
| 18 | Johns Hopkins Medical Center | Baltimore | Maryland | United States | 21231 |
| 19 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
| 20 | New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87109 |
| 21 | New York University (NYU) Cancer Institute | New York | New York | United States | 10016 |
| 22 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 23 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 24 | Vidant Medical Center | Greenville | North Carolina | United States | 27834 |
| 25 | The Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 26 | Toledo Clinic Cancer Center | Toledo | Ohio | United States | 43623 |
| 27 | Hillman Cancer Center / University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 28 | Saint Francis Hospital / Bon Secours - South Carolina | Greenville | South Carolina | United States | 29607 |
| 29 | West Cancer Center & Research Institute | Germantown | Tennessee | United States | 38138 |
| 30 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 31 | UT Health East Texas Hope Cancer Center | Tyler | Texas | United States | 75701 |
| 32 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
| 33 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 34 | Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | United States | 98109 |
| 35 | Site AR54008 | Buenos Aire | Argentina | C1019ABS | |
| 36 | Site AR54006 | La Rioja | Argentina | 5300 | |
| 37 | Site AR54001 | Rosario | Argentina | 2000 | |
| 38 | Site AR54002 | San Miguel | Argentina | T400GTB | |
| 39 | Site AR54012 | Tucuman | Argentina | T4000IAK | |
| 40 | Site AR54003 | Viedma | Argentina | 8500 | |
| 41 | Site AU61003 | Box Hill | Australia | 3128 | |
| 42 | Site AUS61001 | Douglas | Australia | 4814 | |
| 43 | Site AUS61004 | Heidelberg | Australia | 3084 | |
| 44 | Site AUS61002 | Macquarie Park | Australia | 2109 | |
| 45 | Site AUS61006 | South Australia | Australia | 5112 | |
| 46 | Site AU61005 | South Brisbane | Australia | 4101 | |
| 47 | Site BE32003 | Brussels | Belgium | 1200 | |
| 48 | Site BE32002 | Ghent | Belgium | 9000 | |
| 49 | Site BE32001 | Liege | Belgium | 4000 | |
| 50 | Site BE32007 | Lueven | Belgium | 3000 | |
| 51 | Site BE32006 | Roeselare | Belgium | 8800 | |
| 52 | Site CA11004 | Calgary | Alberta | Canada | T2N 4N2 |
| 53 | Site CA11003 | Edmonton | Alberta | Canada | T6G 1Z2 |
| 54 | Site CA11006 | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 55 | Site CA11002 | Hamilton | Ontario | Canada | L8V 1C3 |
| 56 | Site CA11009 | London | Ontario | Canada | N6A 5A5 |
| 57 | Site CA11011 | Oshawa | Ontario | Canada | L1G 2B9 |
| 58 | Site CA11012 | Toronto | Ontario | Canada | M4N 3M5 |
| 59 | Site CA11005 | Toronto | Ontario | Canada | M5G 2M9 |
| 60 | Site CA11010 | Montreal | Quebec | Canada | H2X 0A9 |
| 61 | Site CA11001 | Montreal | Quebec | Canada | H3T 1E2 |
| 62 | Site CA11008 | Quebec | Canada | G1R 2J6 | |
| 63 | Site CZ42006 | Brno | Czechia | 656 91 | |
| 64 | Site CZ42001 | Hradec Kralove | Czechia | 500 05 | |
| 65 | Site CZ42004 | Olomouc | Czechia | 779 00 | |
| 66 | Site CZ42005 | Praha 4-Krc | Czechia | 140 59 | |
| 67 | Site DK45001 | Aalborg | Denmark | 9100 | |
| 68 | Site DK45003 | Aarhus N | Denmark | 8200 | |
| 69 | Site FR33014 | Bordeaux | France | 33000 | |
| 70 | Site FR33016 | Lyon | France | 69373 | |
| 71 | Site FR33003 | Nice Cedex 2 | France | 06189 | |
| 72 | Site FR33020 | Pierre-Bénite | France | 69495 | |
| 73 | Site FR33013 | Strasbourg | France | 67200 | |
| 74 | Site FR33017 | TOURS Cedex 09 | France | 37044 | |
| 75 | Site FR33011 | Villejuif-Cedex-France | France | 94805 | |
| 76 | Site DE49003 | Berlin | Germany | 10117 | |
| 77 | Site DE49013 | Bielefeld | Germany | 33611 | |
| 78 | Site DE49016 | Düsseldorf | Germany | 40225 | |
| 79 | Site DE49014 | Erlangen | Germany | 91054 | |
| 80 | Site DE49011 | Essen | Germany | 45147 | |
| 81 | Site DE49007 | Frankfurt am Main | Germany | 60488 | |
| 82 | Site DE49005 | Heidelberg | Germany | 69120 | |
| 83 | Site DE49009 | Herne | Germany | 44649 | |
| 84 | Site DE49001 | Lubeck | Germany | 23538 | |
| 85 | Site DE49008 | Magdeburg | Germany | 39120 | |
| 86 | Site DE49012 | Mannheim | Germany | 68167 | |
| 87 | Site DE49002 | Munchen | Germany | 81675 | |
| 88 | Site DE49004 | Tübingen | Germany | 72076 | |
| 89 | Site DE49010 | Ulm | Germany | 89081 | |
| 90 | Site HU36003 | Budapest | Hungary | 1083 | |
| 91 | Site HU36002 | Budapest | Hungary | 1122 | |
| 92 | Site HU36006 | Debrecen | Hungary | 4032 | |
| 93 | Site HU36001 | Nyiregyhaza | Hungary | 4400 | |
| 94 | Site HU36005 | Szolnok | Hungary | 5004 | |
| 95 | Site IL97203 | Beer Sheva | Israel | 84101 | |
| 96 | Site IL97201 | Haifa | Israel | 31096 | |
| 97 | Site IL97209 | Holon | Israel | 58100 | |
| 98 | Site IL97206 | Jerusalem | Israel | 91120 | |
| 99 | Site IL97202 | Kfar Saba | Israel | 44281 | |
| 100 | Site IL97208 | Petach Tikva | Israel | 49414 | |
| 101 | Site IL97211 | Rehovot | Israel | 76100 | |
| 102 | Site IL97210 | Tel Aviv | Israel | 64239 | |
| 103 | Site IL97204 | Tel Hashomer | Israel | 52621 | |
| 104 | Site IL97205 | Zerifin | Israel | 70300 | |
| 105 | Site IT39005 | Areezo | Italy | 52100 | |
| 106 | Site IT39008 | Candiolo | Italy | 10060 | |
| 107 | Site IT39009 | Cremona | Italy | 26100 | |
| 108 | Site IT39006 | Genova | Italy | 16132 | |
| 109 | Site IT39003 | Meldola | Italy | 47014 | |
| 110 | Site IT39007 | Milano | Italy | 20141 | |
| 111 | Site IT39004 | Pisa | Italy | 56126 | |
| 112 | Site IT39002 | Terni | Italy | 05100 | |
| 113 | Site IT39011 | Torrette | Italy | 60126 | |
| 114 | Site IT39001 | Verona | Italy | 37134 | |
| 115 | Site JP81002 | Bunkyo City | Japan | ||
| 116 | Site JP81009 | Chiba | Japan | ||
| 117 | Site JP81018 | Chiba | Japan | ||
| 118 | Site JP81013 | Fukuoka | Japan | ||
| 119 | Site JP81020 | Fukuoka | Japan | ||
| 120 | Site JP81011 | Hirosaki | Japan | ||
| 121 | Site JP81006 | Kawasaki-shi | Japan | ||
| 122 | Site JP81001 | Koto-ku | Japan | ||
| 123 | Site JP81017 | Kyoto | Japan | ||
| 124 | Site JP81015 | Niigata | Japan | ||
| 125 | Site JP81005 | Okayama | Japan | ||
| 126 | Site JP81016 | Osakasayama-Shi | Japan | ||
| 127 | Site JP81008 | Osaka | Japan | ||
| 128 | Site JP81007 | Sapporo | Japan | ||
| 129 | Site JP81012 | Sendai-city | Japan | ||
| 130 | Site JP81014 | Tokushima | Japan | ||
| 131 | Site JP81019 | Tokyo | Japan | ||
| 132 | Site JP81003 | Toyama | Japan | ||
| 133 | Site JP81004 | Tsukuba | Japan | ||
| 134 | Site JP81010 | Ube | Japan | ||
| 135 | Site KR82001 | Daejeon | Korea, Republic of | 301-721 | |
| 136 | Site KR82002 | Goyang-si | Korea, Republic of | 10408 | |
| 137 | Site KR82008 | Hwasun | Korea, Republic of | 519-763 | |
| 138 | Site KR82004 | Seongnam-si | Korea, Republic of | 13605 | |
| 139 | Site KR82003 | Seoul | Korea, Republic of | 03722 | |
| 140 | Site KR82005 | Seoul | Korea, Republic of | 05505 | |
| 141 | Site KR82007 | Seoul | Korea, Republic of | 135-710 | |
| 142 | Site KR82006 | Seoul | Korea, Republic of | 137-701 | |
| 143 | Site NL31005 | Amsterdam, Noord-Holland | Netherlands | 1066 CX | |
| 144 | Site NL31002 | Amsterdam | Netherlands | 1066 CX | |
| 145 | Site NL31001 | Amsterdam | Netherlands | 1081 HV | |
| 146 | Site NL31007 | Leeuwarden | Netherlands | 8934 AD | |
| 147 | Site NL31004 | Nieuwegein | Netherlands | 3435 CM | |
| 148 | Site NL31003 | Rotterdam | Netherlands | 3075 EA | |
| 149 | Site NL31006 | Utrecht | Netherlands | 3584 CX | |
| 150 | Site PL48002 | Warszawa | Poland | 01-748 | |
| 151 | Site RU70016 | Arkhangelsk | Russian Federation | 163045 | |
| 152 | Site RU70013 | Barnaul | Russian Federation | 656049 | |
| 153 | Site RU70020 | Ivanovo | Russian Federation | 153040 | |
| 154 | Site RU70014 | Krasnoyarsk | Russian Federation | 660133 | |
| 155 | Site RU70006 | Leningradskaya Oblast' | Russian Federation | 188663 | |
| 156 | Site RU70004 | Moscow | Russian Federation | 105077 | |
| 157 | Site RU70011 | Moscow | Russian Federation | 123056 | |
| 158 | Site RU70003 | Moscow | Russian Federation | 125284 | |
| 159 | Site RU70017 | Nizhniy Novgorod | Russian Federation | 603074 | |
| 160 | Site RU70002 | Omsk | Russian Federation | 644013 | |
| 161 | Site RU70019 | Pyatigorsk | Russian Federation | 357502 | |
| 162 | Site RU70010 | Saint Petersburg | Russian Federation | 195271 | |
| 163 | Site RU70007 | Saint Petersburg | Russian Federation | 197082 | |
| 164 | Site RU70012 | Saint-Petersburg | Russian Federation | 197758 | |
| 165 | Site RU70009 | Saransk | Russian Federation | 430032 | |
| 166 | Site RU70008 | St. Petersburg | Russian Federation | 197758 | |
| 167 | Site RU70015 | Tyumen | Russian Federation | 625041 | |
| 168 | Site RU70005 | Ufa | Russian Federation | 450000 | |
| 169 | Site SG65001 | Singapore | Singapore | 119074 | |
| 170 | Site SG65002 | Singapore | Singapore | 169610 | |
| 171 | Site SG65003 | Singapore | Singapore | 308433 | |
| 172 | Site ES34017 | Barcelona | Spain | 08003 | |
| 173 | Site ES34010 | Barcelona | Spain | 08035 | |
| 174 | Site ES34006 | Barcelona | Spain | 08036 | |
| 175 | Site ES34001 | Barcelona | Spain | 08041 | |
| 176 | Site ES34008 | Barcelona | Spain | 08907 | |
| 177 | Site ES34013 | Cordoba | Spain | 14004 | |
| 178 | Site ES34021 | Lugo | Spain | 27003 | |
| 179 | Site ES34018 | Madrid | Spain | 28007 | |
| 180 | Site ES34002 | Madrid | Spain | 28034 | |
| 181 | Site ES34015 | Madrid | Spain | 28041 | |
| 182 | Site ES34004 | Manresa | Spain | 08243 | |
| 183 | Site ES34020 | Pamplona | Spain | 31008 | |
| 184 | Site ES34016 | Sabadell | Spain | 08208 | |
| 185 | Site ES34012 | Santander | Spain | 39008 | |
| 186 | Site ES34007 | Sevilla | Spain | 41013 | |
| 187 | Site ES34019 | Valencia | Spain | 46009 | |
| 188 | Site ES34009 | Valencia | Spain | 46014 | |
| 189 | Site CH41004 | Basel | Switzerland | 4031 | |
| 190 | Site CH41002 | Bern | Switzerland | 3010 | |
| 191 | Site CH41001 | Chur | Switzerland | 7000 | |
| 192 | Site CH41003 | Winterthur | Switzerland | 8401 | |
| 193 | Site TW88603 | Kaohsiung | Taiwan | 83301 | |
| 194 | Site TW88602 | Kweishan | Taiwan | 333 | |
| 195 | Site TW88607 | Taichung | Taiwan | 40447 | |
| 196 | Site TW88606 | Taichung | Taiwan | 40705 | |
| 197 | Site TW88604 | Tainan | Taiwan | 70403 | |
| 198 | Site TW88605 | Taipei | Taiwan | 10002 | |
| 199 | Site TW88601 | Taipei | Taiwan | 11217 | |
| 200 | Site TH66004 | Bangkok | Thailand | 10330 | |
| 201 | Site TH66003 | Bangkok | Thailand | 10400 | |
| 202 | Site TH66005 | Chiang Mai | Thailand | 50200 | |
| 203 | Site TH66002 | HatYai | Thailand | 90110 | |
| 204 | Site TH66006 | Krung Thep Maha Nakhon | Thailand | 10700 | |
| 205 | Site TH66007 | Muang | Thailand | 40002 | |
| 206 | Site TH66001 | Ratchathewi | Thailand | 10400 | |
| 207 | Site TR90007 | Ankara | Turkey | 6100 | |
| 208 | Site TR90009 | Ankara | Turkey | 6230 | |
| 209 | Site TR90005 | Antalya | Turkey | 07059 | |
| 210 | Site TR90008 | Istanbul | Turkey | 34093 | |
| 211 | Site TR90003 | Istanbul | Turkey | 34214 | |
| 212 | Site TR90002 | Istanbul | Turkey | 81450 | |
| 213 | Site TR90001 | Konya | Turkey | 42080 | |
| 214 | Site TR90006 | Malatya | Turkey | 44280 | |
| 215 | Site UK44005 | Glasgow | United Kingdom | G12 0YN | |
| 216 | Site UK44001 | London | United Kingdom | EC1M 6BQ | |
| 217 | Site UK44009 | London | United Kingdom | W6 8RF | |
| 218 | Site UK44006 | Oxford | United Kingdom | OX3 7LE | |
| 219 | Site UK44010 | Plymouth | United Kingdom | PL6 8DH | |
| 220 | Site UK44002 | Preston | United Kingdom | PR2 9HT | |
| 221 | Site UK44003 | Sheffield | United Kingdom | S10 2RX |
Sponsors and Collaborators
- Astellas Pharma Global Development, Inc.
- Merck Sharp & Dohme LLC
- Seagen Inc.
Investigators
- Study Director: Sujata Narayanan, MD, MS, Seagen Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGN22E-003
- 2019-004542-15
- MK-3475-A39
- KEYNOTE KN-A39
- jRCT2031200284