The purpose of this study is to identify the recommended Phase 2 dose (RP2D) and schedule of erdafitinib in combination with cetrelimab (Phase 1b) and to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in first line metastatic urothelial carcinoma (mUC) setting (Phase 2).
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 of erdafitinib
plus cetrelimab in participants with advanced urothelial cancer with selected fibroblast
growth factor receptor (FGFR) gene alterations, will consists of 2 parts. Participants
enrolled in Part 1 may have received any number of lines of prior therapy, and participants
enrolled in Part 2 will have had no prior systemic therapy for metastatic disease and
cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will establish recommended Phase 2 dose
(RP2D) for erdafitinib in combination with cetrelimab, and Part 2 (Phase 2: Dose Expansion)
will evaluate safety and efficacy of RP2D. 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: Approximately up to 8 weeks
Primary Outcome 2 - Measure: Phase 1b: Number of Participants with Adverse Events (AEs)
Primary Outcome 2 - Time Frame: Approximately up to 2 years
Primary Outcome 3 - 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 3 - Time Frame: Approximately up to 2 years
Primary Outcome 4 - Measure: Phase 2: Number of Participants with AEs
Primary Outcome 4 - Time Frame: Approximately 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) Phase 1b: Any number of
lines of prior therapy; (b) Phase 2: No prior systemic therapy for metastatic disease
and cisplatin-ineligible
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: 0, 1, or 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
- Chemotherapy within 3 weeks of Cycle 1 Day 1
- 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
- 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 |
---|---|---|
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 |
Recruiting | |
Maryland Oncology Hematology, PA Rockville, Maryland 20850 United States |
Recruiting | |
Nevada Cancer Institute Las Vegas, Nevada 89169 United States |
Withdrawn | |
Hackensack University Medical Center Hackensack, New Jersey 07601 United States |
Recruiting | |
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 |
Recruiting | |
Levine Cancer Institute, Carolinas HealthCare System Charlotte, North Carolina 28204 United States |
Not yet recruiting | |
Toledo Clinic Cancer Centers Toledo, Ohio 43623-3536 United States |
Recruiting | |
St. Luke's University Health Network Bethlehem, Pennsylvania 18015 United States |
Withdrawn | |
Penn State Hershey Cancer Institute Hershey, Pennsylvania 17033 United States |
Not yet recruiting | |
Texas Oncology, P.A. Fort Worth, Texas 76104 United States |
Recruiting | |
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 | |
Gomel Regional Clinical Hospital Gomel, 246012 Belarus |
Not yet recruiting | |
Grodno Regional Clinical Hospital Grodno, 230017 Belarus |
Not yet recruiting | |
State Institution N.N. Alexandrov Republican Scientific and Lesnoy, 223040 Belarus |
Not yet recruiting | |
Minsk city Clinical Oncological Dispensary Minsk, 220013 Belarus |
Not yet recruiting | |
Mogilev Regional Hospital Mogilev, 212018 Belarus |
Not yet recruiting | |
Vitebsk Regional Clinical Hospital Vitebsk, 210603 Belarus |
Not yet recruiting | |
Cliniques Universitaires Saint-Luc Brussel, 1200 Belgium |
Recruiting | |
ULB Hôpital Erasme Bruxelles, 1070 Belgium |
Not yet 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 |
Not yet recruiting | |
GZA Ziekenhuizen- Campus St Augustinus Wilrijk, 2610 Belgium |
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 |
Not yet recruiting | |
Centre Hospitalier Départemental VENDEE La Roche Sur Yon, 85925 France |
Not yet recruiting | |
Centre hospitalier Saint Louis La Rochelle Cedex 1, 17019 France |
Not yet recruiting | |
Centre Leon Bérard Lyon, 69008 France |
Not yet recruiting | |
APHM Hopital Timone Marseille, 13005 France |
Not yet 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 |
Not yet 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 |
Not yet recruiting | |
Policlinico Universitario Di Cagliari Cagliari, 09134 Italy |
Not yet recruiting | |
Istituto di Candiolo, IRCCS Candiolo, 10060 Italy |
Not yet recruiting | |
Ospedale Di Zona B Ramazzini Carpi, 41012 Italy |
Not yet recruiting | |
UOS Oncologia Medica, A.O. Cannizzaro Catania, 95126 Italy |
Not yet recruiting | |
P.O. Ss. Annunziata Chieti Scalo, 66013 Italy |
Not yet recruiting | |
Arcispedale S. Anna Ferrara Ferrara, 44124 Italy |
Not yet recruiting | |
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco Lecco, 23900 Italy |
Not yet 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 |
Not yet recruiting | |
AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto Piacenza, 29121 Italy |
Not yet recruiting | |
Azienda USL Toscana Nord Ovest Pontedera (PI), 56025 Italy |
Not yet recruiting | |
Arcispedale Santa Maria Nuova - IRCCS Reggio Emilia, 42123 Italy |
Not yet recruiting | |
Campus Bio-Medico di Roma Roma, 00128 Italy |
Not yet 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 |
Not yet recruiting | |
Azienda Ospedaliera S. Maria Terni Terni, 05100 Italy |
Not yet recruiting | |
Azienda Ospedaliero Universitaria S.Maria Della Misericordia Udine, 33100 Italy |
Not yet 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 |
Not yet recruiting | |
Kangbuk Samsung Hospital Seoul, 03181 Korea, Republic of |
Not yet recruiting | |
Severance Hospital Seoul, 03722 Korea, Republic of |
Not yet recruiting | |
Asan Medical Center Seoul, 05505 Korea, Republic of |
Not yet recruiting | |
The Catholic University of Korea, Seoul St.Mary's Hospital Seoul, 06591 Korea, Republic of |
Not yet recruiting | |
SMG - SNU Boramae Medical Center Seoul, 07061 Korea, Republic of |
Not yet recruiting | |
The Catholic University of Korea St. Vincent's Hospital Suwon-si, 16247 Korea, Republic of |
Not yet recruiting | |
Pusan National University Yangsan Hospital Yangsan, 50612 Korea, Republic of |
Not yet recruiting | |
Altai Regional Oncology Dispensary Barnaul, 656049 Russian Federation |
Recruiting | |
Ivanovo Regional Oncology Dispensary Ivanovo, 153040 Russian Federation |
Not yet recruiting | |
GUZ Kursk Regional Oncology Dispensary Kislino Village, Ryshkovsky Ru, 305524 Russian Federation |
Not yet recruiting | |
Leningrad Regional Oncology Dispensary Kuzmolovsky, 188663 Russian Federation |
Not yet recruiting | |
City Clinical Hospital n.a. D.D.Pletnev Moscow, 105077 Russian Federation |
Not yet recruiting | |
Russian Scientific Center of Roentgenoradiology Moscow, 117997 Russian Federation |
Not yet recruiting | |
Moscow City Clinical Hospital # 62 Moscow, 125130 Russian Federation |
Recruiting | |
Privolzhsky District Medical Centre Nizhny Novgorod, 603074 Russian Federation |
Not yet 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 |
Not yet 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 |
Not yet recruiting | |
GBUZ 'Regional clinical oncologic dispensary of Volgograd' Volgograd, 400138 Russian Federation |
Withdrawn | |
Hosp. Del Mar Barcelona, 08003 Spain |
Not yet recruiting | |
Hosp. Clinic I Provincial de Barcelona Barcelona, 08036 Spain |
Recruiting | |
Hosp. Univ. Ramon Y Cajal Madrid, 28034 Spain |
Not yet recruiting | |
Hosp. Clinico San Carlos Madrid, 28040 Spain |
Not yet 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 |
Not yet recruiting | |
Complexo Hosp. Univ. de Ourense Ourense, 32005 Spain |
Not yet recruiting | |
Complejo Hospitalario de Vigo Pontevedra, 36204 Spain |
Not yet 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 | |
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 |
Not yet recruiting | |
St Bartholomew's Hospital London, EC1A 7BE United Kingdom |
Not yet recruiting | |
University College London Hospitals Nhs Foundation Trust / Division Of Gi Services London, NW1 2PG United Kingdom |
Not yet recruiting | |
Kings College London at Guy's Hospital London, W1G 6AD United Kingdom |
Not yet recruiting | |
Nottingham University Hospitals NHS Trust Nottingham, NG5 1PB United Kingdom |
Recruiting |