Bladder Cancer Clinical Trial

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers

Summary

The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2, to determine one or more additional RP2Ds in Parts 3 and 4 and to evaluate JNJ-63723283 subcutaneous (SC) administration pharmacokinetics (PK) compared to JNJ-63723238 intravenous (IV) administration (Part 5).

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Full Description

This is a First in Human (FIH), open-label (all people involved know the identity of the intervention), multicenter (more than 1 study site) study in participants with advanced cancers to establish the recommended Phase 2 dose (RP2D[s]) with IV administration for JNJ-63723283 in Part 1, to evaluate the safety and efficacy of the IV RP2D(s) in Part 2, to determine a SC RP2D in Part 3 and Part 4 and to evaluate JNJ-63723283 SC administration PK compared to JNJ-63723283 IV administration in Part 5. Participant participation will include a Screening Phase (28 Days) during which participant eligibility will be reviewed prior to administration of the first dose of JNJ-63723283; a Treatment Phase that will start at the first dose and continue until treatment is discontinued; and a Survival Follow-up Phase (applicable for Parts 1, 2 and 5) starting upon completion of the End-of-Treatment Visit and ends when the participant completes or withdraws from the study. The end of the study is defined as last study assessment for the last participant on study or if the sponsor terminates the study, whichever comes first. Participants safety will be monitored throughout the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Parts 1-5: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
Parts 1-5: Has thyroid function laboratory values within normal range
Parts 1-5: Females of childbearing potential must have a negative serum pregnancy test
Parts 1-5: Willing and able to adhere to the prohibitions and restrictions specified in this protocol
For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy
Parts 1 to 4: Have evaluable disease; For Part 5 only: at least 1 measurable lesion that can be accurately assessed at baseline by computed tomography (CT) and is suitable for repeated assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
For Part 5 only: Has a histologically or cytologically confirmed diagnosis of unresectable Stage III or Stage IV cutaneous or mucosal melanoma. Individuals with uveal or ocular melanoma are excluded
For Part 5 only: Up to 1 line of prior therapy for melanoma is allowed with the exception of prior anti-programmed-cell death receptor-1 (anti-PD-1) antibody, anti-PD-L1 antibody, or anti-PD-L2 antibody therapy
For Part 5 only- Participants enrolled into Part 5 must have tumor tissue available for central determination of PD-L1 status. The exception is participants who do not have sufficient tissue available for central testing, in which case a Sponsor-approved local assay may be accepted

Exclusion Criteria:

Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody
Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 halflives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration
Grade 3 or higher toxicity effects from previous treatment with immunotherapy
A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

600

Study ID:

NCT02908906

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 107 Locations for this study

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Washington University School of Medicine
Saint Louis Missouri, 63110, United States
UPMC Cancer Centers
Pittsburgh Pennsylvania, 15232, United States
CINME - Centro de Investigaciones Metabolicas
Buenos Aires , C1027, Argentina
Sanatorio Allende
Córdoba , X5000, Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba , X5008, Argentina
Hospital Privado Universitario de Córdoba
Córdoba , X5016, Argentina
Hospital Italiano de La Plata
La Plata , 1900, Argentina
Sanatorio de la Mujer
Rosario , 2000, Argentina
Fundacao Pio XII
Barretos , 14784, Brazil
PERSONAL - Oncologia de Precisão e Personalizada
Belo Horizonte , 30130, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo horizonte , 30150, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiania , 74605, Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí , 88301, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre , 90035, Brazil
União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS
Porto Alegre , 90610, Brazil
Ministerio da Saude - Instituto Nacional do Cancer
Rio de Janeiro , 20220, Brazil
Oncoclínicas Rio de Janeiro S.A.
Rio de Janeiro , 22250, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Rio de Janeiro , 22281, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Salvador , 41253, Brazil
Clinica de Hematologia e Oncologia Viver Ltda
Santa Maria , 97015, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
Sao Paulo , 01246, Brazil
Fundação Antônio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Hospital do Coração - HCor
Sao Paulo , 04004, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Multiprofile Hospital for Active Treatment Heart and Brain, Pleven
Pleven , 5800, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv , 4004, Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia , 1756, Bulgaria
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
Charite Universitaetsmedizin Berlin
Berlin , 10117, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main , 60590, Germany
Semmelweis Egyetem AOK
Budapest , 1085, Hungary
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Pécs , 7632, Hungary
Kidwai Memorial Institute of Oncology
Bangalore N/a , 56002, India
Srinivasam Cancer Care & Multispeciality Hospitals (I) Pvt Ltd
Bengaluru , 56007, India
Artemis Hospital
Gurugram , 12200, India
Nizams Institute of Medical Sciences NIMS
Hyderabad , 50008, India
Kgmu Hospital
Lucknow , 22600, India
Tata Memorial Hospital
Mumbai , 40001, India
All India Institute of Medical Sciences
New Delhi , 11002, India
IMS and SUM Hospital
Odisha , 75100, India
Deenanath Mangeshkar Hospital and Research Centre
Pune , 41100, India
Sanjeevani CBCC USA Cancer Hospital
Raipur , 49200, India
Surat Institute of Digestive Sciences Hospitals
Surat , 39500, India
Christian medical
Vellore , 63200, India
Ospedali Riuniti Di Ancona
Ancona , 60126, Italy
Ospedale San Giuseppe Moscati di Avellino
Avellino , 83100, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , 47014, Italy
Istituto Europeo di Oncologia Servizio Radioterapia
Milano , 20141, Italy
San Gerardo Hospital
Monza , 20052, Italy
IRCCS-Fondazione Pascale
Napoli , 80131, Italy
Aou San Luigi Gonzaga
Orbassano , 10043, Italy
Istituto Clinico Humanitas
Rozzano , 20089, Italy
Azienda Ospedaliera Universitaria Senese
Siena , 53100, Italy
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
CIAME
Cancun , 77506, Mexico
Centro Estatal de Cancerología de Chihuahua
Chihuahua , 31000, Mexico
ONCARE Viaducto Napoles
Ciudad de Mexico , 03810, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara , 44280, Mexico
Centro de Atención e Investigación Clínica en Oncología
Merida , 97134, Mexico
Instituto Nacional de Cancerologia
Mexico , 14080, Mexico
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
Monterrey , 64460, Mexico
i Can Oncology Center
Monterrey , 64710, Mexico
Arensia Exploratory Medicine
Chisinau , MD-20, Moldova, Republic of
Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc i Gruzlicy
Bialystok , 15-54, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Instituto Portugues de Oncologia
Lisboa , 1099-, Portugal
Chln - Hosp. Santa Maria
Lisboa , 1649-, Portugal
FSBSI 'N. N. Blokhin Russian Cancer Research Center'
Moscow , 11547, Russian Federation
Pyatigorsky Oncology Dispensary
Pyatigorsk , 35750, Russian Federation
BioEk, LLC
St. Petersburg , 19734, Russian Federation
City Oncology Dispensary
St. Petersburg , 19825, Russian Federation
City Oncology Dispensary
St. Petersburg , 19825, Russian Federation
Hosp. Univ. Germans Trias I Pujol
Badalona , 8916, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 8035, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28009, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Virgen de La Victoria
Malaga , 29010, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Sahlgrenska University Hospital
Goteborg , 41345, Sweden
Vajira Hospital
Bangkok , 10300, Thailand
King Chulalongkorn Memorial Hospital
Bangkok , 10330, Thailand
Siriraj Hospital
Bangkok , 10700, Thailand
Chiang Mai University
Chiangmai , 50200, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen , 40000, Thailand
Adana City Hospital
Adana , 01170, Turkey
Başkent University Medical Faculty Adana Application and Research Center
Adana , 01250, Turkey
Memorial Ankara Hospital
Ankara , 06520, Turkey
Gazi University Medical Faculty
Ankara , 06560, Turkey
Liv Hospital Ankara
Ankara , 06680, Turkey
Ankara Bilkent City Hospital
Ankara , 6800, Turkey
Trakya University Medical Faculty
Edirne , 22030, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istabul , 34098, Turkey
Medipol Mega University Hospital
Istabul , 34214, Turkey
Bezmialem Vakif University Medical Faculty Hospital
Istanbul , 34093, Turkey
Bakirkoy Training and Research Hospital
İstanbul , 34147, Turkey
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul , 34384, Turkey
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul , 34722, Turkey
Marmara University Medical Faculty
Istanbul , 34899, Turkey
Ege University Medical Faculty
Izmir , 35100, Turkey
Beatson West Of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Sarah Cannon Research Institute
London , W1G 6, United Kingdom
The Christie Nhs Foundation Trust
Manchester , M20 4, United Kingdom
Sir Bobby Robson Unit, Northern Centre for Cancer Care
Newcastle upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

600

Study ID:

NCT02908906

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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