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
🇺🇸Orange, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Tennessee Medical Center Knoxville
🇺🇸Knoxville, Tennessee, United States
GU Research Network-Urology Cancer Center
🇺🇸Omaha, Nebraska, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Macquarie University Hospital
🇦🇺Macquarie Park, Australia
Hopital de Jolimont
🇧🇪Haine-Saint-Paul, Belgium
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
CHU de Besancon
🇫🇷Besançon, France
Moncton Hospital - Horizon Health Network
🇨🇦Moncton, New Brunswick, Canada
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
CHU de Quebec - Hotel-Dieu de Quebec
🇨🇦Québec, Quebec, Canada
Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
🇩🇪Luebeck, Schleswig Holstein, Germany
Institut Bergonie
🇫🇷Bordeaux, France
Cork University Hospital
🇮🇪Cork, Ireland
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
🇺🇸Chattanooga, Tennessee, United States
Austin Health-Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Adelaide Cancer Centre
🇦🇺Kurralta Park, Australia
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
CHU de Strasbourg - Nouvel Hopital Civil
🇫🇷Strasbourg, France
Adelaide & Meath Hospital (Incl NCH)
🇮🇪Dublin, Ireland
University College Hospital Galway
🇮🇪Galway, Ireland
C.H.U. de Tours - Hopital Bretonneau
🇫🇷Tours, France
Kliniken Essen Mitte
🇩🇪Essen, Germany
Klinikum rechts der Isar der Technischen Universitat
🇩🇪Muenchen, Germany
Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Rambam Health Care Campus
🇮🇱Haifa, Israel
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
University Hospital Waterford
🇮🇪Waterford, Ireland
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego
🇵🇱Katowice, Poland
Urologica Praktyka Lekarska Adam Marcheluk
🇵🇱Siedlce, Poland
China Medical University Hospital
🇨🇳Taichung, Taiwan
VU University Medical Center
🇳🇱Amsterdam, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Krankenhaus der Barmherzigen Brueder Trier
🇩🇪Trier, Germany
Ryazan Regional Clinical Oncology Dispensary
🇷🇺Ryazan, Russian Federation
Rabin Medical Center
🇮🇱Petach-Tikwa, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Europejskie Centrum Zdrowia Otwock
🇵🇱Otwock, Poland
Istituto Nazionale dei Tumori
🇮🇹Milan, Italy
Medical Hospital, Tokyo Medical And Dental University
🇯🇵Tokyo, Japan
Soroka Medical Center
🇮🇱Be'er Sheva, Israel
Universitaetsklinikum Magdeburg A.o.R.
🇩🇪Magdeburg, Germany
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Ivanovo Regional Oncology Dispensary
🇷🇺Ivanovo, Russian Federation
Antoni van Leeuwenhoek Ziekenhuis
🇳🇱Amsterdam, Netherlands
Meir Medical Center
🇮🇱Kfar Saba, Israel
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Istituto Nazionale Tumori IRCCS Fondazione Pascale
🇮🇹Napoli, Italy
Hospital Teresa Herrera - Chuac
🇪🇸A Coruña, Spain
Pokrovskaya City Hospital
🇷🇺Saint Petersburg, Russian Federation
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
🇵🇱Jelenia Góra, Poland
GLOBE Badania Kliniczne Oddzial we Wroclawiu
🇵🇱Komorowice, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
🇵🇱Szczecin, Poland
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Russian Scientific Center of Roentgenoradiology
🇷🇺Moscow, Russian Federation
Chang Gung Medical Foundation - Kaohsiung
🇨🇳Kaohsiung, Taiwan
MI Odessa Regional Oncological Centre
🇺🇦Odesa, Ukraine
Erasmus MC
🇳🇱Rotterdam, Netherlands
ICO L Hospitalet
🇪🇸Hospitalet de Llobregat, Spain
Tokushima University Hospital
🇯🇵Tokushima, Japan
National Medical Research Radiological Centre
🇷🇺Moscow, Russian Federation
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
🇺🇦Dnipropetrovsk, Ukraine
Magodent Szpital Elblaska
🇵🇱Warszawa, Poland
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Kharkiv Regional Clinical Oncology Center
🇺🇦Kharkiv, Ukraine
RMI Sumy Regional Clinical Oncology Dispensary
🇺🇦Sumy, Ukraine
GZA Sint Augustinus
🇧🇪Wilrijk, Belgium
Institut Jules Bordet
🇧🇪Bruxelles, Belgium
Grand Hopital de Charleroi - Site Notre Dame - Oncology
🇧🇪Charleroi, Belgium
AZ Maria Middelares Gent
🇧🇪Gent, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology Nashville
🇺🇸Nashville, Tennessee, United States
Texas Oncology-Memorial City
🇺🇸Houston, Texas, United States
Centre d Oncologie de Gentilly
🇫🇷Nancy, France
Institut de Cancerologie de l Ouest Site Paul Papin
🇫🇷Angers, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Arizona Oncology Associates PC- HOPE
🇺🇸Tucson, Arizona, United States
Woodlands Medical Specialists, PA
🇺🇸Pensacola, Florida, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
🇺🇸New York, New York, United States
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Institut Jean Godinot
🇫🇷Reims, France
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Institut Gustave Roussy
🇫🇷Villejuif, France
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
University Hospital Limerick
🇮🇪Limerick, Ireland
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Medical Oncology Ospedale San Donato
🇮🇹Arezzo, Italy
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST
🇮🇹Meldola, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
University of Tsukuba Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Amphia Ziekenhuis
🇳🇱Breda, Brabant, Netherlands
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne
🇵🇱Warszawa, Poland
Leningrad Regional Oncology Dispensary
🇷🇺Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russian Federation
Taipei Veterans General Hospital
🇨🇳Taipei, Beitou, Taiwan
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov
🇺🇦Dnipropetrovsk, Ukraine
Kyiv City Clinical Oncology Center
🇺🇦Kyiv, Ukraine
Royal Marsden NHS Trust
🇬🇧Sutton, Surrey, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
🇬🇧London, United Kingdom
Plymouth Hospitals NHS Trust
🇬🇧Plymouth, United Kingdom
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Medical University of South Carolina-Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Southern Medical Day Care Centre
🇦🇺Wollongong, New South Wales, Australia
Institut Paoli Calmettes
🇫🇷Marseille, France
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Consorci Hospitalari Parc Tauli de Sabadell
🇪🇸Sabadell, Spain
Universitaetsklinikum Jena
🇩🇪Jena, Germany
Hospital General Universitari Vall d Hebron
🇪🇸Barcelona, Spain
Nara Medical University Hospital
🇯🇵Kashihara, Nara, Japan
N.N. Blokhin NMRCO
🇷🇺Moscow, Russian Federation
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Clinic of Bashkortostan State Medical University
🇷🇺Ufa, Russian Federation
Xarxa Assistencial Universitaria Manresa
🇪🇸Manresa, Spain
Beskidzkie Centrum Onkologii im. Jana Pawla II
🇵🇱Bielsko-Biala, Poland
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
University of Washington
🇺🇸Seattle, Washington, United States
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom