To learn more about biomarkers such as the FGFR mutations in this trial, please click here, or copy and paste this link into your browser: https://content.gtc-api.dev/sites/default/files/2020-08/GTC_OnlineEngagement-ENG09_Biomarkers_V1.0_040220_Final.mp4
The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.
This open-label (all people know identity of intervention) and multicenter (when more than
one hospital or medical school team work on a medical research study) study to establish the
recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or platinum (cisplatin or
carboplatin) chemotherapy, and the safety of erdafitinib in combination with cetrelimab and
platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of
erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced
urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations.
Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any
number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib +
cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for
metastatic disease and participants enrolled in Phase 2 will have had no prior systemic
therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation)
will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab +
platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) in
which the erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab
combination are evaluated to further characterize safety and clinical activity. The study
will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study
evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers,
and safety.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | April 5, 2018 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: Phase 1b: Percentage of Participants with Dose-Limiting Toxicity (DLT)
Primary Outcome 1 - Time Frame: Up to 8 weeks
Primary Outcome 2 - Measure: Phase 2: Overall Response Rate (ORR) (Partial Response [PR] or Better) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
Primary Outcome 2 - Time Frame: Up to 2 years
Primary Outcome 3 - Measure: Phase 2: Number of Participants with Adverse Event (AEs)
Primary Outcome 3 - Time Frame: Up to 2 years
Criteria:
Inclusion Criteria:
- Histologic demonstration of transitional cell carcinoma of the urothelium. Variant
urothelial carcinoma histologies such as glandular or squamous differentiation, or
evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change
are acceptable
- Metastatic or locally advanced urothelial cancer
- Must have measurable disease by radiological imaging according to the Response
Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
- Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib
+ cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b
erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for
metastatic disease; and renal function for participants must have a creatinine
clearance (CrCl) greater than (>) 50 milliliter per minute (mL/min) as calculated by
Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and
cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria:
Renal function defined as creatinine clearance (CrCl) ˂60 mL/min as calculated by
Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0;
Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase
1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab +
platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase
2: ECOG 0-2
Exclusion Criteria:
- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b,
participants who have received the following prior antitumor therapy: received
nitrosoureas and mitomycin C within 6 weeks
- Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day
1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior
neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given >12 months
prior to recurrent disease progression and did not result in drug-related toxicity
leading to treatment discontinuation
- Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1),
or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant
checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12
months prior to recurrent disease progression and did not result in drug-related
toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder
cancer is also allowed
- Active malignancies requiring concurrent therapy other than urothelial cancer
- Symptomatic central nervous system metastases
Show More
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Janssen Research & Development, LLC Clinical Trial
Role: Study Director
Affiliation: Janssen Research & Development, LLC
Name: Study Contact
Phone: 844-434-4210
Email: JNJ.CT@sylogent.com
Link: To learn how to participate in this trial please click here.
Facility | Status | Contact |
---|---|---|
University of California Irvine Orange, California 92868 United States |
Not yet recruiting | |
Rocky Mountain Cancer Centers Aurora, Colorado 80012 United States |
Recruiting | |
University of Iowa Hospital and Clinic Iowa City, Iowa 52242 United States |
Withdrawn | |
Norton Cancer Institute Louisville, Kentucky 40202 United States |
Completed | |
Maryland Oncology Hematology, PA Rockville, Maryland 20850 United States |
Recruiting | |
University of Michigan Health System Ann Arbor, Michigan 48109-5000 United States |
Withdrawn | |
Nevada Cancer Institute Las Vegas, Nevada 89169 United States |
Withdrawn | |
Hackensack University Medical Center Hackensack, New Jersey 07601 United States |
Completed | |
Weill Cornell Medical College - NY Presbyterian Hospital New York, New York 10021 United States |
Recruiting | |
White Plains Hospital Center for Cancer Care White Plains, New York 10601 United States |
Completed | |
Levine Cancer Institute, Carolinas HealthCare System Charlotte, North Carolina 28204 United States |
Recruiting | |
Toledo Clinic Cancer Centers Toledo, Ohio 43623-3536 United States |
Completed | |
St. Luke's University Health Network Bethlehem, Pennsylvania 18015 United States |
Withdrawn | |
Penn State Hershey Cancer Institute Hershey, Pennsylvania 17033 United States |
Recruiting | |
Texas Oncology, P.A. Fort Worth, Texas 76104 United States |
Completed | |
The University of Texas MD Anderson Cancer Center Houston, Texas 77030 United States |
Recruiting | |
The University of Texas MD Anderson Cancer Center San Antonio, Texas 78229-3931 United States |
Withdrawn | |
University of Oklahoma Health Sciences Center San Antonio, Texas 78229 United States |
Withdrawn | |
Virginia Oncology Associates Norfolk, Virginia 23502 United States |
Recruiting | |
Brest Regional Oncology Dispensary Brest, 224027 Belarus |
Recruiting | |
Gomel Regional Clinical Oncology Dispensary Gomel, 246012 Belarus |
Recruiting | |
Grodno University Hospital Grodno, 230017 Belarus |
Recruiting | |
State Institution N.N. Alexandrov Republican Scientific and Lesnoy, 223040 Belarus |
Recruiting | |
Minsk city Clinical Oncological Dispensary Minsk, 220013 Belarus |
Recruiting | |
Mogilev Regional Hospital Mogilev, 212018 Belarus |
Recruiting | |
Vitebsk Regional Clinical Hospital Vitebsk, 210603 Belarus |
Recruiting | |
Cliniques Universitaires Saint-Luc Brussel, 1200 Belgium |
Completed | |
ULB Hôpital Erasme Bruxelles, 1070 Belgium |
Recruiting | |
Jolimont Haine-Saint-Paul, La Louviere, 7100 Belgium |
Recruiting | |
Az Groeninge Kortrijk, 8500 Belgium |
Recruiting | |
CHU de Liège - Domaine Universitaire du Sart Tilman Liege, 4000 Belgium |
Recruiting | |
AZ Nikolaas - Campus Sint-Niklaas Moerland Sint-Niklaas, 9100 Belgium |
Recruiting | |
GZA Ziekenhuizen- Campus St Augustinus Wilrijk, 2610 Belgium |
Recruiting | |
Fundacao Pio Xii - Hospital De Cancer De Barretos Barreto, 14784-400 Brazil |
Not yet recruiting | |
Santa Casa de Misericordia de Belo Horizonte Belo Horizonte, 30150-221 Brazil |
Not yet recruiting | |
Hospital Erasto Gaertner Curitiba, 81520-060 Brazil |
Not yet recruiting | |
Oncocentro Ceará Fortaleza, 60170-170 Brazil |
Not yet recruiting | |
Hospital de Clínicas de Porto Alegre Porto Alegre, 90035-903 Brazil |
Not yet recruiting | |
INCA - Instituto Nacional Do Cancer Rio De Janeiro, 20230-130 Brazil |
Not yet recruiting | |
Oncoclínicas Rio De Janeiro, 22250-905 Brazil |
Not yet recruiting | |
COI - Clinicas Oncologicas Integradas Rio De Janeiro, 22793-080 Brazil |
Not yet recruiting | |
CEPHO - Faculdade de Medicina do ABC Santo Andre, 09060-650 Brazil |
Not yet recruiting | |
Instituto do Cancer do Estado de Sao Paulo ICESP São Paulo, 01246-000 Brazil |
Not yet recruiting | |
Institut de Cancerologie de Ouest (ICO) Site Paul Papin Angers Cedex 02, 49055 France |
Recruiting | |
Hopital Saint André Bordeaux, 33075 France |
Recruiting | |
Centre Francois Baclesse Caen, 14000 France |
Recruiting | |
Centre Hospitalier Départemental VENDEE La Roche Sur Yon, 85925 France |
Withdrawn | |
Centre hospitalier Saint Louis La Rochelle Cedex 1, 17019 France |
Recruiting | |
Centre Leon Bérard Lyon, 69008 France |
Recruiting | |
APHM Hopital Timone Marseille, 13005 France |
Recruiting | |
Hôpital Européen Georges Pompidou Paris, 75015 France |
Recruiting | |
Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré Reims, 51092 France |
Withdrawn | |
Clinique Sainte Anne Strasbourg, 67000 France |
Recruiting | |
Institut Universitaire du Cancer Toulouse Oncopole Toulouse, 31000 France |
Withdrawn | |
CHRU de Tours Tours, 37044 France |
Recruiting | |
Institut de Cancérologie de Lorraine Vandoeuvre lès Nancy, 54519 France |
Recruiting | |
Institut Gustave Roussy Villejuif, 94800 France |
Recruiting | |
LTD 'Aversi Clinic' T'bilisi, 0160 Georgia |
Withdrawn | |
Institute for Personalized Medicine LTD Tbilisi, 0186 Georgia |
Withdrawn | |
Research Institute of Clinical Medicine Tbilisi, 112 Georgia |
Withdrawn | |
LTD Mammological Center Named after K Madichi Tblisi, 0159 Georgia |
Withdrawn | |
Cliniche Humanitas Gavazzeni Bergamo, 24125 Italy |
Recruiting | |
Policlinico Universitario Di Cagliari Cagliari, 09134 Italy |
Not yet recruiting | |
Istituto di Candiolo, IRCCS Candiolo, 10060 Italy |
Recruiting | |
Ospedale Di Zona B Ramazzini Carpi, 41012 Italy |
Recruiting | |
UOS Oncologia Medica, A.O. Cannizzaro Catania, 95126 Italy |
Recruiting | |
P.O. Ss. Annunziata Chieti Scalo, 66013 Italy |
Withdrawn | |
Arcispedale S. Anna Ferrara Ferrara, 44124 Italy |
Recruiting | |
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco Lecco, 23900 Italy |
Recruiting | |
Ospedale Civile Di Livorno Livorno, 57122 Italy |
Recruiting | |
IRCCS Ospedale San Raffaele Milano, 20132 Italy |
Recruiting | |
ASST Grande Ospedale Metropolitano Niguarda Milano, 20162 Italy |
Recruiting | |
Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica Perugia, 06132 Italy |
Recruiting | |
AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto Piacenza, 29121 Italy |
Recruiting | |
Arcispedale Santa Maria Nuova - IRCCS Reggio Emilia, 42123 Italy |
Not yet recruiting | |
Campus Bio-Medico di Roma Roma, 00128 Italy |
Recruiting | |
PO Ospedale S.Anna, ASST Lariana San Fermo della Battaglia, 22042 Italy |
Not yet recruiting | |
Azienda Socio Sanitaria Territoriale (ASST) della Valtellin Sondrio, 23100 Italy |
Recruiting | |
Azienda Ospedaliera S. Maria Terni Terni, 05100 Italy |
Recruiting | |
Azienda Ospedaliero Universitaria S.Maria Della Misericordia Udine, 33100 Italy |
Recruiting | |
Chungnam National University Hospital Daejeon, 35015 Korea, Republic of |
Recruiting | |
Chonnam National University Hospital Gwangju, 61469 Korea, Republic of |
Recruiting | |
Chonnam National University Hwasun Hospital Jeonnam, 58128 Korea, Republic of |
Withdrawn | |
CHA Bundang Medical center, CHA University Seongnam, 13496 Korea, Republic of |
Withdrawn | |
Seoul National University Hospital Seoul, 03080 Korea, Republic of |
Completed | |
Kangbuk Samsung Hospital Seoul, 03181 Korea, Republic of |
Recruiting | |
Severance Hospital Seoul, 03722 Korea, Republic of |
Recruiting | |
Asan Medical Center Seoul, 05505 Korea, Republic of |
Recruiting | |
The Catholic University of Korea, Seoul St.Mary's Hospital Seoul, 06591 Korea, Republic of |
Recruiting | |
SMG - SNU Boramae Medical Center Seoul, 07061 Korea, Republic of |
Recruiting | |
The Catholic University of Korea St. Vincent's Hospital Suwon-si, 16247 Korea, Republic of |
Recruiting | |
Pusan National University Yangsan Hospital Yangsan, 50612 Korea, Republic of |
Recruiting | |
Przychodnia Lekarska KOMED Roman Karaszewski Konin, 62-500 Poland |
Recruiting | |
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz, 93-513 Poland |
Not yet recruiting | |
LUX MED Onkologia Sp. z o.o. Warszawa, 01-748 Poland |
Not yet recruiting | |
Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa, 02-507 Poland |
Not yet recruiting | |
Altai Regional Oncology Dispensary Barnaul, 656049 Russian Federation |
Recruiting | |
Ivanovo Regional Oncology Dispensary Ivanovo, 153040 Russian Federation |
Recruiting | |
GUZ Kursk Regional Oncology Dispensary Kislino Village, Ryshkovsky Ru, 305524 Russian Federation |
Recruiting | |
Leningrad Regional Oncology Dispensary Kuzmolovsky, 188663 Russian Federation |
Recruiting | |
City Clinical Hospital n.a. D.D.Pletnev Moscow, 105077 Russian Federation |
Recruiting | |
Russian Scientific Center of Roentgenoradiology Moscow, 117997 Russian Federation |
Recruiting | |
Moscow City Clinical Hospital # 62 Moscow, 125130 Russian Federation |
Recruiting | |
Clinical Diagnostic Centre of Nizhny Novgorod Region Nizhny Novgorod, 603000 Russian Federation |
Recruiting | |
Privolzhsky District Medical Centre Nizhny Novgorod, 603074 Russian Federation |
Recruiting | |
Clinical Oncology Dispensary Omsk, 644013 Russian Federation |
Recruiting | |
LLC Novaya Clinica Pyatigorsk, 357500 Russian Federation |
Recruiting | |
Clinical Hospital #122 n.a. after L.G. Sokolov Saint Petersburg, 194291 Russian Federation |
Withdrawn | |
City Polyprofiled Hospital #2 Saint Petersburg, 194354 Russian Federation |
Withdrawn | |
Private Medical Institution Euromedservice Saint Petersburg, 196603 Russian Federation |
Recruiting | |
Clinical and research Oncological Center Saint Petersburg, 197758 Russian Federation |
Withdrawn | |
Russian Scientific Center of Radiology and Surgical Technologies Saint-Petersburg, 197758 Russian Federation |
Recruiting | |
City Pokrovskaya Hospital St Petersburg, 199106 Russian Federation |
Withdrawn | |
Tambov Regional Oncology Clinical Dispansary Tambov, 392013 Russian Federation |
Recruiting | |
Multifunctional clinical medical center 'Medical city' Tyumen, 625041 Russian Federation |
Recruiting | |
GBUZ 'Regional clinical oncologic dispensary of Volgograd' Volgograd, 400138 Russian Federation |
Withdrawn | |
Hosp. Del Mar Barcelona, 08003 Spain |
Recruiting | |
Hosp. Clinic I Provincial de Barcelona Barcelona, 08036 Spain |
Recruiting | |
Hosp. Univ. Ramon Y Cajal Madrid, 28034 Spain |
Recruiting | |
Hosp. Clinico San Carlos Madrid, 28040 Spain |
Recruiting | |
Hosp. Univ. Fund. Jimenez Diaz Madrid, 28050 Spain |
Recruiting | |
Hosp. Univ. Hm Sanchinarro Madrid, 28050 Spain |
Recruiting | |
Hosp. Virgen de La Victoria Málaga, 29010 Spain |
Recruiting | |
Complexo Hosp. Univ. de Ourense Ourense, 32005 Spain |
Recruiting | |
Complejo Hospitalario de Vigo Pontevedra, 36204 Spain |
Recruiting | |
Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcon, 28223 Spain |
Recruiting | |
Corporacio Sanitari Parc Tauli Sabadell, 08208 Spain |
Recruiting | |
Hosp. Univ. Marques de Valdecilla Santander, 39008 Spain |
Recruiting | |
H. Clinico Universitario de Santiago de Compostela Santiago de Compostela, 15706 Spain |
Recruiting | |
Hosp. Virgen Macarena Sevilla, 41009 Spain |
Recruiting | |
Hosp. Virgen Del Rocio Sevilla, 41013 Spain |
Recruiting | |
Instituto Valenciano de Oncologia Valencia, 46009 Spain |
Recruiting | |
Hosp. Clinico Univ. de Valencia Valencia, 46010 Spain |
Recruiting | |
Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, 83301 Taiwan |
Not yet recruiting | |
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung, 807 Taiwan |
Not yet recruiting | |
China Medical University Hospital Taichung City, 40447 Taiwan |
Not yet recruiting | |
National Cheng Kung University Hospital Tainan, 70403 Taiwan |
Recruiting | |
National Taiwan University Hospital Taipei City, 10002 Taiwan |
Not yet recruiting | |
Chang-Gung Memorial Hospital, LinKou Branch Taoyuan, 333 Taiwan |
Not yet recruiting | |
Adana Baskent Yuregir Hospital Adana, 01250 Turkey |
Not yet recruiting | |
Adana Acibadem Hospital Adana, 1130 Turkey |
Not yet recruiting | |
Memorial Ankara Hastanesi Ankara, 06520 Turkey |
Not yet recruiting | |
Hacettepe University Medical Faculty Ankara, 6100 Turkey |
Recruiting | |
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, 6200 Turkey |
Recruiting | |
Adnan Menderes University Training and Research Hospital Aydin, 09100 Turkey |
Recruiting | |
Trakya University Medical Faculty Edirne, 22030 Turkey |
Recruiting | |
Istanbul University Cerrahpasa Medical Faculty Istanbul, 34096 Turkey |
Recruiting | |
Istanbul Medeniyet University Goztepe Training and Research Hospital Istanbul, 34732 Turkey |
Recruiting | |
Ege University Izmir, 35100 Turkey |
Not yet recruiting | |
Kocaeli University Medical Faculty Kocaeli, Turkey |
Recruiting | |
Necmettin Erbakan University Meram Medical Faculty Konya, 42080 Turkey |
Recruiting | |
Karadeniz Teknik University Medical Faculty Trabzon, 61080 Turkey |
Recruiting | |
Addenbrooke's Hospital Cambridge, CB2 0QQ United Kingdom |
Withdrawn | |
Colchester Hospital University NHS Colchester, CO4 5JL United Kingdom |
Withdrawn | |
Royal Lancaster Infirmary Lancaster, LA1 4rp United Kingdom |
Recruiting | |
St Bartholomew's Hospital London, EC1A 7BE United Kingdom |
Recruiting | |
University College London Hospitals Nhs Foundation Trust / Division Of Gi Services London, NW1 2PG United Kingdom |
Recruiting | |
Kings College London at Guy's Hospital London, W1G 6AD United Kingdom |
Withdrawn | |
Nottingham University Hospitals NHS Trust Nottingham, NG5 1PB United Kingdom |
Recruiting |