Study Summary
This trial is testing a combination of two drugs to treat bladder cancer that has spread to other places in the body and has genetic alterations in FGFR2/3 genes. The first drug, erdafitinib, works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. The second drug, enfortumab vedotin, is a monoclonal antibody that attaches to a protein called nectin-4 on cancer cells and delivers an anticancer drug to kill them. The combination of these two drugs may help to shrink or stabilize the cancer.
Eligible Conditions
- Renal Pelvis Urothelial Carcinoma
- Stage IV Ureter Cancer
- Urothelial Carcinoma Recurrent
- Bladder Cancer
- Stage IV Urethral Cancer
- Stage IV Renal Pelvis Cancer
- Urethral Urothelial Carcinoma
- Stage IV Bladder Cancer
- Urothelial Carcinoma
- Metastatic Urothelial Carcinoma of the Ureter
- Metastatic Urothelial Carcinoma of the Renal Pelvis
- Urothelial Carcinoma Bladder Recurrent
- Ureter Urothelial Carcinoma
- Recurrent Ureteral Urothelial Carcinoma
- Stage IVA Bladder Cancer
- Stage IVB Bladder Cancer
- Recurrent Urothelial Carcinoma of the Renal Pelvis
- Recurrent Urethral Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: Up to 2 years
Year 2
Duration of response
Year 2
Progression free survival
Up to 2 years
Assessment of tumor subtyping, tumor microenvironment, and mutations associated with treatment response
Incidence of adverse events
Year 2
Mechanisms of resistance and response
Overall response rate
Overall survival
PD-L1 and Nectin-4 expression
Pharmacokinetics (PK)
Pharmakinetics (PK)
Tumor subtyping, tumor microenvironment, and mutations associated with treatment response
Up to 28 days
Maximum tolerated dose of enfortumab vedotin
Recommended phase II dose
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (erdafitinib, enfortumab vedotin)
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Erdafitinib · No Placebo Group · Phase 1
Treatment (erdafitinib, enfortumab vedotin)Experimental Group · 4 Interventions: Computed Tomography, Biospecimen Collection, Enfortumab Vedotin, Erdafitinib · Intervention Types: Procedure, Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Biospecimen Collection
2004
Completed Phase 1
~670
Erdafitinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,076 Previous Clinical Trials
41,139,518 Total Patients Enrolled
1 Trials studying Renal Pelvis Urothelial Carcinoma
54 Patients Enrolled for Renal Pelvis Urothelial Carcinoma
Rohit JainPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have disease progression during or following treatment with at least one platinum-containing regimen (e.g.
You have received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease.
You have had local muscle-invasive UC for 12 months or less.
Patients who received immune checkpoint inhibitor therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 12 months of therapy completion are eligible.
Patients with metastatic urothelial carcinoma who are cisplatin-ineligible and progressed on upfront immune checkpoint inhibitor therapy; or ineligible/refused immune checkpoint inhibitor therapy will be eligible for this trial.
Patients who received prior antibody drug conjugate such as sacituzumab govitecan are allowed.
Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Patients must have FGFR2/3 activating alterations identified by tumor tissue or plasma ctDNA profiling using a Clinical Laboratory Improvement Act (CLIA) certified College of American Pathologists (CAP) accredited platform.
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Conditions
Cancer Related
Treatments