Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
- Conditions
- UC (Urothelial Cancer)
- Interventions
- Registration Number
- NCT03361865
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
- Measurable disease based on RECIST v1.1.
- Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
- Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
- Adequate organ function per protocol-defined criteria.
- Disease that is suitable for local therapy administered with curative intent.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
- Known history of or is positive for active hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
- History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption.
- History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
- Use of protocol-defined prior/concomitant therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab 200 mg + epacadostat 100 mg BID Epacadostat Pembrolizumab + epacadostat Pembrolizumab 200 mg + epacadostat 100 mg BID Pembrolizumab Pembrolizumab + epacadostat Pembrolizumab 200 mg + placebo BID Placebo Pembrolizumab + placebo Pembrolizumab 200 mg + placebo BID Pembrolizumab Pembrolizumab + placebo
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo Week 9 ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.
- Secondary Outcome Measures
Name Time Method Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs) Up to approximately 25 months AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE Up to approximately 25 months AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Trial Locations
- Locations (143)
University of California Irvine Medical Center
๐บ๐ธOrange, California, United States
Yale Cancer Center
๐บ๐ธNew Haven, Connecticut, United States
University of Tennessee Medical Center Knoxville
๐บ๐ธKnoxville, Tennessee, United States
GU Research Network-Urology Cancer Center
๐บ๐ธOmaha, Nebraska, United States
Quincy Medical Group
๐บ๐ธQuincy, Illinois, United States
Macquarie University Hospital
๐ฆ๐บMacquarie Park, Australia
Hopital de Jolimont
๐ง๐ชHaine-Saint-Paul, Belgium
Sunnybrook Health Science Centre
๐จ๐ฆToronto, Ontario, Canada
Universitair Ziekenhuis Gent
๐ง๐ชGent, Belgium
Universitaetsklinikum Tuebingen
๐ฉ๐ชTuebingen, Germany
CHU de Besancon
๐ซ๐ทBesanรงon, France
Moncton Hospital - Horizon Health Network
๐จ๐ฆMoncton, New Brunswick, Canada
Calvary Mater Newcastle
๐ฆ๐บWaratah, New South Wales, Australia
CHU de Quebec - Hotel-Dieu de Quebec
๐จ๐ฆQuรฉbec, Quebec, Canada
Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
๐ฉ๐ชLuebeck, Schleswig Holstein, Germany
Institut Bergonie
๐ซ๐ทBordeaux, France
Cork University Hospital
๐ฎ๐ชCork, Ireland
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
๐บ๐ธChattanooga, Tennessee, United States
Austin Health-Austin Hospital
๐ฆ๐บHeidelberg, Victoria, Australia
Adelaide Cancer Centre
๐ฆ๐บKurralta Park, Australia
Centre Jean Perrin
๐ซ๐ทClermont-Ferrand, France
CHU de Strasbourg - Nouvel Hopital Civil
๐ซ๐ทStrasbourg, France
Adelaide & Meath Hospital (Incl NCH)
๐ฎ๐ชDublin, Ireland
University College Hospital Galway
๐ฎ๐ชGalway, Ireland
C.H.U. de Tours - Hopital Bretonneau
๐ซ๐ทTours, France
Kliniken Essen Mitte
๐ฉ๐ชEssen, Germany
Klinikum rechts der Isar der Technischen Universitat
๐ฉ๐ชMuenchen, Germany
Istituto Tumori Giovanni Paolo II
๐ฎ๐นBari, Italy
Rambam Health Care Campus
๐ฎ๐ฑHaifa, Israel
Nagoya University Hospital
๐ฏ๐ตNagoya, Aichi, Japan
University Hospital Waterford
๐ฎ๐ชWaterford, Ireland
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego
๐ต๐ฑKatowice, Poland
Urologica Praktyka Lekarska Adam Marcheluk
๐ต๐ฑSiedlce, Poland
China Medical University Hospital
๐จ๐ณTaichung, Taiwan
VU University Medical Center
๐ณ๐ฑAmsterdam, Netherlands
Catharina Ziekenhuis
๐ณ๐ฑEindhoven, Netherlands
Krankenhaus der Barmherzigen Brueder Trier
๐ฉ๐ชTrier, Germany
Ryazan Regional Clinical Oncology Dispensary
๐ท๐บRyazan, Russian Federation
Rabin Medical Center
๐ฎ๐ฑPetach-Tikwa, Israel
Sourasky Medical Center
๐ฎ๐ฑTel Aviv, Israel
Europejskie Centrum Zdrowia Otwock
๐ต๐ฑOtwock, Poland
Istituto Nazionale dei Tumori
๐ฎ๐นMilan, Italy
Medical Hospital, Tokyo Medical And Dental University
๐ฏ๐ตTokyo, Japan
Soroka Medical Center
๐ฎ๐ฑBe'er Sheva, Israel
Universitaetsklinikum Magdeburg A.o.R.
๐ฉ๐ชMagdeburg, Germany
Chaim Sheba Medical Center
๐ฎ๐ฑRamat Gan, Israel
Ivanovo Regional Oncology Dispensary
๐ท๐บIvanovo, Russian Federation
Antoni van Leeuwenhoek Ziekenhuis
๐ณ๐ฑAmsterdam, Netherlands
Meir Medical Center
๐ฎ๐ฑKfar Saba, Israel
University Medical Center Groningen
๐ณ๐ฑGroningen, Netherlands
Istituto Nazionale Tumori IRCCS Fondazione Pascale
๐ฎ๐นNapoli, Italy
Hospital Teresa Herrera - Chuac
๐ช๐ธA Coruรฑa, Spain
Pokrovskaya City Hospital
๐ท๐บSaint Petersburg, Russian Federation
Hospital Infanta Cristina
๐ช๐ธBadajoz, Spain
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
๐ต๐ฑJelenia Gรณra, Poland
GLOBE Badania Kliniczne Oddzial we Wroclawiu
๐ต๐ฑKomorowice, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
๐ต๐ฑSzczecin, Poland
Severance Hospital Yonsei University Health System
๐ฐ๐ทSeoul, Korea, Republic of
Russian Scientific Center of Roentgenoradiology
๐ท๐บMoscow, Russian Federation
Chang Gung Medical Foundation - Kaohsiung
๐จ๐ณKaohsiung, Taiwan
MI Odessa Regional Oncological Centre
๐บ๐ฆOdesa, Ukraine
Erasmus MC
๐ณ๐ฑRotterdam, Netherlands
ICO L Hospitalet
๐ช๐ธHospitalet de Llobregat, Spain
Tokushima University Hospital
๐ฏ๐ตTokushima, Japan
National Medical Research Radiological Centre
๐ท๐บMoscow, Russian Federation
Hospital Virgen del Rocio
๐ช๐ธSevilla, Spain
Hospital Universitario Lucus Augusti
๐ช๐ธLugo, Spain
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
๐บ๐ฆDnipropetrovsk, Ukraine
Magodent Szpital Elblaska
๐ต๐ฑWarszawa, Poland
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Abramson Cancer Center of the University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
Kharkiv Regional Clinical Oncology Center
๐บ๐ฆKharkiv, Ukraine
RMI Sumy Regional Clinical Oncology Dispensary
๐บ๐ฆSumy, Ukraine
GZA Sint Augustinus
๐ง๐ชWilrijk, Belgium
Institut Jules Bordet
๐ง๐ชBruxelles, Belgium
Grand Hopital de Charleroi - Site Notre Dame - Oncology
๐ง๐ชCharleroi, Belgium
AZ Maria Middelares Gent
๐ง๐ชGent, Belgium
AZ Nikolaas
๐ง๐ชSint-Niklaas, Belgium
Comprehensive Cancer Centers of Nevada
๐บ๐ธLas Vegas, Nevada, United States
Sarah Cannon Research Institute
๐บ๐ธNashville, Tennessee, United States
Tennessee Oncology Nashville
๐บ๐ธNashville, Tennessee, United States
Texas Oncology-Memorial City
๐บ๐ธHouston, Texas, United States
Centre d Oncologie de Gentilly
๐ซ๐ทNancy, France
Institut de Cancerologie de l Ouest Site Paul Papin
๐ซ๐ทAngers, France
Centre Hospitalier Lyon Sud
๐ซ๐ทPierre-Bรฉnite, France
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
๐จ๐ฆMontreal, Quebec, Canada
Kindai University Hospital
๐ฏ๐ตOsakasayama, Osaka, Japan
The Cancer Institute Hospital of JFCR
๐ฏ๐ตTokyo, Japan
Yamaguchi University Hospital
๐ฏ๐ตUbe, Yamaguchi, Japan
Arizona Oncology Associates PC- HOPE
๐บ๐ธTucson, Arizona, United States
Woodlands Medical Specialists, PA
๐บ๐ธPensacola, Florida, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
๐บ๐ธNew York, New York, United States
Cancer Centre of Southeastern Ontario at Kingston General Hospital
๐จ๐ฆKingston, Ontario, Canada
Institut Jean Godinot
๐ซ๐ทReims, France
Universitaetsklinikum Duesseldorf
๐ฉ๐ชDuesseldorf, Germany
Institut Gustave Roussy
๐ซ๐ทVillejuif, France
Universitatsklinikum Hamburg-Eppendorf
๐ฉ๐ชHamburg, Germany
University Hospital Limerick
๐ฎ๐ชLimerick, Ireland
Assaf Harofeh Medical Center
๐ฎ๐ฑZerifin, Israel
Medical Oncology Ospedale San Donato
๐ฎ๐นArezzo, Italy
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST
๐ฎ๐นMeldola, Italy
Istituto Oncologico Veneto
๐ฎ๐นPadova, Italy
University of Tsukuba Hospital
๐ฏ๐ตTsukuba, Ibaraki, Japan
Amphia Ziekenhuis
๐ณ๐ฑBreda, Brabant, Netherlands
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne
๐ต๐ฑWarszawa, Poland
Leningrad Regional Oncology Dispensary
๐ท๐บSaint Petersburg, Leningrad Region, Vsevolozhsky District, Russian Federation
Taipei Veterans General Hospital
๐จ๐ณTaipei, Beitou, Taiwan
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov
๐บ๐ฆDnipropetrovsk, Ukraine
Kyiv City Clinical Oncology Center
๐บ๐ฆKyiv, Ukraine
Royal Marsden NHS Trust
๐ฌ๐งSutton, Surrey, United Kingdom
Imperial College Healthcare NHS Trust
๐ฌ๐งLondon, United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
๐ฌ๐งLondon, United Kingdom
Plymouth Hospitals NHS Trust
๐ฌ๐งPlymouth, United Kingdom
The Beatson West of Scotland Cancer Centre
๐ฌ๐งGlasgow, United Kingdom
Sunderland Royal Hospital
๐ฌ๐งSunderland, United Kingdom
Levine Cancer Institute
๐บ๐ธCharlotte, North Carolina, United States
Fox Chase Cancer Center
๐บ๐ธPhiladelphia, Pennsylvania, United States
Willamette Valley Cancer Institute and Research Center
๐บ๐ธEugene, Oregon, United States
Medical University of South Carolina-Hollings Cancer Center
๐บ๐ธCharleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center
๐บ๐ธNashville, Tennessee, United States
Southern Medical Day Care Centre
๐ฆ๐บWollongong, New South Wales, Australia
Institut Paoli Calmettes
๐ซ๐ทMarseille, France
The Ottawa Hospital Cancer Centre
๐จ๐ฆOttawa, Ontario, Canada
National Cancer Center Hospital East
๐ฏ๐ตKashiwa, Chiba, Japan
Hopital Europeen Georges Pompidou
๐ซ๐ทParis, France
Institut Claudius Regaud
๐ซ๐ทToulouse, France
Consorci Hospitalari Parc Tauli de Sabadell
๐ช๐ธSabadell, Spain
Universitaetsklinikum Jena
๐ฉ๐ชJena, Germany
Hospital General Universitari Vall d Hebron
๐ช๐ธBarcelona, Spain
Nara Medical University Hospital
๐ฏ๐ตKashihara, Nara, Japan
N.N. Blokhin NMRCO
๐ท๐บMoscow, Russian Federation
Chungnam National University Hospital
๐ฐ๐ทDaejeon, Korea, Republic of
Seoul National University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Clinic of Bashkortostan State Medical University
๐ท๐บUfa, Russian Federation
Xarxa Assistencial Universitaria Manresa
๐ช๐ธManresa, Spain
Beskidzkie Centrum Onkologii im. Jana Pawla II
๐ต๐ฑBielsko-Biala, Poland
National Cheng Kung University Hospital
๐จ๐ณTainan, Taiwan
National Taiwan University Hospital
๐จ๐ณTaipei, Taiwan
University of Washington
๐บ๐ธSeattle, Washington, United States
Royal Free London NHS Foundation Trust
๐ฌ๐งLondon, United Kingdom