WithdrawnPhase 2

Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial

Stopped: Feasibility issues

0Started 2023-10-12

Plain-language summary

This phase II trial compares the effect of erdafitinib alone to using the combination of erdafitinib and atezolizumab in treating patients with bladder cancer whose tumor invades the muscular bladder wall (muscle invasive)and who are ineligible for treatment with a chemotherapy drug called cisplatin. This trial also determines whether these treatment approaches are better than the usual approach for treating this type of cancer. The usual approach for treatment of someone with muscle invasive bladder cancer is chemotherapy with a drug called cisplatin followed by surgery (most common), or chemoradiation (radiation combined with chemotherapy) to the bladder (in some patients). However, half of the patients cannot get cisplatin due to safety concerns. This study has a screening step. The purpose of this step is to test patient's tumor to find out if it has a specific change (alteration) in the fibroblast growth factor receptor (FGFR) gene to determine patient's eligibility for this trial. Alteration of the FGFR gene causes bladder cancer cells to grow and divide abnormally. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein. 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 erdafitinib alone or in combination with atezolizumab may help to shrink tumor cells at the time of surgery better than the usual treatment in muscle invasive bladder cancer.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patients must have muscle-invasive disease, tumor stage T2-T4, N0-1, based on transurethral resection of bladder tumor (TURBT) performed within 8 weeks prior to enrollment * Clinical stage T2-T4, N0 or N1, M0 by CT chest abdomen pelvis (or CT chest and MRI abdomen pelvis). Ultrasound, fluorine-18-fluorodeoxyglucose positron emission tomography (FDG-PET), and plain x-rays are not acceptable methods of evaluating clinical staging in the absence of CT or MRI scans * Histologically-confirmed urothelial carcinoma. Urothelial carcinoma with variant differentiation is allowed regardless of percentage. Other variant histology is allowed if urothelial carcinoma is the predominant histology (\>= 50%), except neuroendocrine (any neuroendocrine carcinoma would be an exclusion criteria) * Patients must be eligible and planned for curative-intent RC, as determined by a urologic oncologist * Patients who are ineligible for or decline cisplatin-based chemotherapy. * Cisplatin-ineligibility defined as \>= 1 of the following criteria (modified from the Galsky criteria): Eastern Cooperative Oncology Group (ECOG) performance status (PS) of \>= 2, either estimated or measured creatinine clearance (CrCl) or glomerular filtrate rate (GFR) \< 60 mL/min, Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 grade \>= 2 audiometric hearing loss or grade \>= 2 peripheral neuropathy * For cisplatin-eligible patients who decline cisplatin-based neoadjuvant chemo…

What they're measuring

Pathological complete response (pCR)

Timeframe: Up to 2 years

Trial details

NCT IDNCT05564416

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-01-01