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).
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.
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
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There are 123 Locations for this study
Saint Louis Missouri, 63110, United States
Pittsburgh Pennsylvania, 15232, United States
Buenos Aires , C1027, Argentina
Córdoba , X5000, Argentina
Córdoba , X5008, Argentina
Córdoba , X5016, Argentina
La Plata , 1900, Argentina
Rosario , 2000, Argentina
Rosario , 2000, Argentina
Barretos , 14784, Brazil
Belo Horizonte , 30130, Brazil
Belo horizonte , 30150, Brazil
Goiania , 74605, Brazil
Itajaí , 88301, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90610, Brazil
Rio de Janeiro , 20220, Brazil
Rio de Janeiro , 22250, Brazil
Rio de Janeiro , 22281, Brazil
Salvador , 41253, Brazil
Santa Maria , 97015, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01509, Brazil
Sao Paulo , 04004, Brazil
São Paulo , 01455, Brazil
Pleven , 5800, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1756, Bulgaria
Marseille , 13005, France
Nice Cedex 3 , 06200, France
Berlin , 10117, Germany
Frankfurt am Main , 60590, Germany
Tübingen , 72076, Germany
Budapest , 1085, Hungary
Pécs , 7632, Hungary
Bangalore N/a , 56002, India
Bengaluru , 56007, India
Gurugram , 12200, India
Hyderabad , 50008, India
Lucknow , 22600, India
Mumbai , 40001, India
New Delhi , 11002, India
Odisha , 75100, India
Pune , 41100, India
Raipur , 49200, India
Surat , 39500, India
Vellore , 63200, India
Ancona , 60126, Italy
Avellino , 83100, Italy
Meldola , 47014, Italy
Milano , 20141, Italy
Monza , 20052, Italy
Napoli , 80131, Italy
Napoli , 80138, Italy
Orbassano , 10043, Italy
Roma , 00128, Italy
Rozzano , 20089, Italy
Siena , 53100, Italy
Siena , 53100, Italy
Hidaka , 350-1, Japan
Niigata , 951-8, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Cancun , 77506, Mexico
Chihuahua , 31000, Mexico
Ciudad de Mexico , 03810, Mexico
Guadalajara , 44280, Mexico
Merida , 97134, Mexico
Mexico , 14080, Mexico
Monterrey , 64460, Mexico
Monterrey , 64710, Mexico
Veracruz , C.P. , Mexico
Chisinau , MD-20, Moldova, Republic of
Bialystok , 15-54, Poland
Warszawa , 02-78, Poland
Lisboa , 1099-, Portugal
Lisboa , 1649-, Portugal
Lisboa , 1998-, Portugal
Porto , 4200-, Portugal
Moscow , 11547, Russian Federation
Pyatigorsk , 35750, Russian Federation
St. Petersburg , 19734, Russian Federation
St. Petersburg , 19825, Russian Federation
St. Petersburg , 19825, Russian Federation
Badalona , 8916, Spain
Barcelona , 8035, Spain
Donostia , 20014, Spain
Las Palmas de Gran Canaria , 35016, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Murcia , 30120, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Valencia , 46014, Spain
Goteborg , 41345, Sweden
Bangkok , 10300, Thailand
Bangkok , 10330, Thailand
Bangkok , 10700, Thailand
Chiangmai , 50200, Thailand
Khon Kaen , 40000, Thailand
Adana , 01170, Turkey
Adana , 01250, Turkey
Ankara , 06520, Turkey
Ankara , 06560, Turkey
Ankara , 06680, Turkey
Ankara , 6800, Turkey
Edirne , 22030, Turkey
Istabul , 34098, Turkey
Istabul , 34214, Turkey
Istanbul , 34093, Turkey
İstanbul , 34147, Turkey
Istanbul , 34384, Turkey
Istanbul , 34722, Turkey
Istanbul , 34899, Turkey
Izmir , 35100, Turkey
Glasgow , G12 0, United Kingdom
London , W1G 6, United Kingdom
Manchester , M20 4, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
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