Arm II (erdafitinib, atezolizumab) for Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bladder Cancer+7 MoreBiospecimen Collection - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial test whether erdafitinib with or without atezolizumab works in treating patients with bladder cancer that invades the muscular wall of the bladder and has a change or alteration in a specific gene called the FGFR. This alteration of the FGFR gene causes bladder cancer cells to grow and divide abnormally. The usual treatment for someone with bladder cancer invading the muscular wall is chemotherapy with a drug called cisplatin. However, half of the patients cannot get cisplatin due to safety concerns. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the combination of erdafitinib and atezolizumab may help to shrink tumor cells at the time of surgery more than treatment with erdafitinib alone.

Eligible Conditions
  • Bladder Cancer
  • Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Stage II Bladder Cancer
  • Stage IV Bladder Cancer
  • Stage III Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: At 2 years

Year 2
Incidence of adverse events
At 2 years
Overall survival (OS) rate
At week 10
Clinical complete response (cCR) rate among patients who do not undergo RC
Clinical partial response (cPR) rate among patients who do not undergo RC
Pathologic clinical response (pCR)
Year 2
Disease-free survival (DFS)
Year 2
Rate of pathologic downstaging (=< pT1N0M0) among all patients who receive radical cystoscopy (RC)
Up to 2 years
Clinical staging (cT2N0 vs. cT3/T4 or N)
Cell fusion procedure
Fibroblast Growth Factor
Urothelium
Pathological complete response (pCR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm I (erdafitinib)
1 of 2
Arm II (erdafitinib, atezolizumab)
1 of 2

Active Control

Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: Arm II (erdafitinib, atezolizumab) · No Placebo Group · Phase 2

Arm II (erdafitinib, atezolizumab)Experimental Group · 6 Interventions: Biospecimen Collection, Atezolizumab, Erdafitinib, Cystoscopy, Computed Tomography, Magnetic Resonance Imaging · Intervention Types: Procedure, Biological, Drug, Procedure, Procedure, Procedure
Arm I (erdafitinib)ActiveComparator Group · 5 Interventions: Biospecimen Collection, Erdafitinib, Cystoscopy, Computed Tomography, Magnetic Resonance Imaging · Intervention Types: Procedure, Drug, Procedure, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~670
Atezolizumab
2016
Completed Phase 4
~7560
Erdafitinib
2017
Completed Phase 1
~110
Cystoscopy
2016
Completed Phase 4
~800
Computed Tomography
2017
Completed Phase 2
~3410
Magnetic Resonance Imaging
2017
Completed Early Phase 1
~1270

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,084 Previous Clinical Trials
41,141,594 Total Patients Enrolled
Di Maria JiangPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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