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

Use our guide to learn which trials are right for you!

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
32
sites
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Vallejo, California 94589
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
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...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30318
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
119-143 Missenden Road
Camperdown, 2050
?
mi
from
Camperdown,
Click here to add this to my saved trials
1021 Morehead Medical Drive
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbia, South Carolina 65212
?
mi
from
Columbia, SC
Click here to add this to my saved trials
3225 Gallows Road
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
5000 South 5th Avenue
Hines, Illinois 60141
?
mi
from
Hines, IL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
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...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Meridian, Idaho 83642
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orange, Florida 32763
?
mi
from
Orange, FL
Click here to add this to my saved trials
625 North 6th Street
Phoenix, Arizona 85004
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Reno, NV
Click here to add this to my saved trials
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Helena, California 94574
?
mi
from
Saint Helena, CA
Click here to add this to my saved trials
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...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials