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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05564416
Phase
PHASE2
Status
Withdrawn

Conditions

  • Bladder Carcinoma
  • Bladder Urothelial Carcinoma
  • Muscle Invasive Bladder Carcinoma
  • Renal Pelvis and Ureter Urothelial Carcinoma
  • Stage II Bladder Cancer AJCC v8
  • Stage III Bladder Cancer AJCC v8
  • Stage IVA Bladder Cancer AJCC v8
  • Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Biospecimen Collection — PROCEDURE
    Correlative studies
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cystoscopy — PROCEDURE
    Undergo cystoscopy
  • Erdafitinib — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Oct 12, 2023
Status verified
Oct 2025
Primary completion
Jan 1, 2024
Completion
Jan 1, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (erdafitinib)
    Patients receive erdafitinib orally (PO). Patients undergo collection of blood and computed tomography (CT)/magnetic resonance imaging (MRI) at various time points throughout the trial and colposcopy at baseline.
  • Experimental: Arm II (erdafitinib, atezolizumab)
    Patients receive erdafitinib PO and atezolizumab intravenously (IV). Patients undergo collection of blood and CT/MRI at various time points throughout the trial and colposcopy at baseline.

Primary Outcome Measure

Pathological complete response (pCR) [ Time Frame: Up to 2 years ]

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