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BRIEF TITLE: Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283 (Cetrelimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Metastatic or Locally Advanced Urothelial Cancer With Selected FGFR Gene Alterations

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer


  • Org Study ID: CR108445
  • Secondary ID: 2017-001980-19,42756493BLC2002
  • NCT ID: NCT03473743
  • NCT Alias:
  • Sponsor: Janssen Research & Development, LLC - Industry
  • Source: Janssen Research & Development, LLC

Description

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

Brief Summary

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.

Detailed Description


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 Outcomes:

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

Condition:

  • Urothelial Carcinoma

Eligibility

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

Official Information

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Study Contact

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

Link: To learn how to participate in this trial please click here.

Locations

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
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
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
Not yet 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
Terminated
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
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
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
Not yet recruiting
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
Lecco, 23900
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
Not yet recruiting
AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto
Piacenza, 29121
Italy
Recruiting
Azienda USL Toscana Nord Ovest
Pontedera (PI), 56025
Italy
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
Recruiting
Azienda Ospedaliera S. Maria Terni
Terni, 05100
Italy
Recruiting
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine, 33100
Italy
Not yet recruiting
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic of
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
Recruiting
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
Not yet recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513
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
Not yet 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
Hacettepe University Medical Faculty
Ankara, 6100
Turkey
Not yet recruiting
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 6200
Turkey
Not yet recruiting
Adnan Menderes University Training and Research Hospital
Aydin, 09100
Turkey
Not yet recruiting
Trakya University Medical Faculty
Edirne, 22030
Turkey
Not yet recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34096
Turkey
Not yet recruiting
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34732
Turkey
Not yet recruiting
Ege University
Izmir, 35100
Turkey
Not yet recruiting
Kocaeli University Medical Faculty
Kocaeli,
Turkey
Not yet recruiting
Necmettin Erbakan University Meram Medical Faculty
Konya, 42080
Turkey
Not yet recruiting
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
Turkey
Not yet 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
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
Withdrawn
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
United Kingdom
Recruiting