A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 23, 2018
End Date:November 5, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or
pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast
growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments,
at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not
containing an anti-PD-(L) 1 agent (cohort 2).

A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or
vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial
cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments,
at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not
containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase
(from randomization until disease progression, intolerable toxicity, withdrawal of consent or
decision by investigator to discontinue treatment, post-treatment followup (from
end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of
study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported
outcomes, medical resource utilization and safety will be assessed.

Inclusion Criteria:

- Histologic demonstration of transitional cell carcinoma of the urothelium. Minor
components ( less than [<] 50 percent [%] overall) of variant histology such as
glandular or squamous differentiation, or evolution to more aggressive phenotypes such
as sarcomatoid or micropapillary change are acceptable

- Metastatic or surgically unresectable urothelial cancer

- Documented progression of disease, defined as any progression that requires a change
in treatment, prior to randomization

- Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination
therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior
treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment.
Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease
progression within 12 months of the last dose are considered to have received systemic
therapy in the metastatic setting.

- A woman of childbearing potential who is sexually active must have a negative
pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or
serum)

- Participants must meet appropriate molecular eligibility criteria

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

- Adequate bone marrow, liver, and renal function

Exclusion Criteria:

- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 30 days prior to randomization

- Active malignancies (that is, requiring treatment change in the last 24 months). The
only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24
months that is considered completely cured, localized prostate cancer with a gleason
score of 6 (treated within the last 24 months or untreated and under surveillance) and
localized prostate cancer with a gleason score of 3+4 that has been treated more than
6 months prior to full study screening and considered to have a very low risk of
recurrence.

- Symptomatic central nervous system metastases

- Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment

- Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients

- Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of
any grade.

- History of uncontrolled cardiovascular disease

- Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers,
known gastric ulcers, or unhealed incisions
We found this trial at
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3225 Gallows Road
Fairfax, Virginia 22031
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Vallejo, California 94589
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30318
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Aurora, Colorado 80045
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119-143 Missenden Road
Camperdown, 2050
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1021 Morehead Medical Drive
Charlotte, North Carolina 28204
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303 East Superior Street
Chicago, Illinois 60611
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Columbia, South Carolina 65212
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Hershey, Pennsylvania 17033
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5000 South 5th Avenue
Hines, Illinois 60141
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Houston, Texas 77030
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Louisville, Kentucky 40207
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Meridian, Idaho 83642
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New York, New York 10021
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Orange, Florida 32763
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625 North 6th Street
Phoenix, Arizona 85004
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Sacramento, California 95817
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Saint Helena, California 94574
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Washington, District of Columbia 20007
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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