NCT05564416

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

Withdrawn Phase 2 Last updated 21 October 2025

What this trial tests

Phase 2 trial testing Atezolizumab in Bladder Carcinoma. Withdrawn.

Timeline

12 October 2023

Primary endpoint
1 January 2024

1 January 2024

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	12 October 2023
Primary completion	1 January 2024
Estimated completion	1 January 2024

Drugs / interventions tested

• Atezolizumab (atezolizumab) — full drug profile →
• Biospecimen Collection — full drug profile →
• Biospecimen Collection — full drug profile →
• Computed Tomography
• Cystoscopy
• Erdafitinib (ERDAFITINIB) — full drug profile →
• Magnetic Resonance Imaging

Conditions studied

• Bladder Carcinoma — all drugs for Bladder Carcinoma →
• Bladder Urothelial Carcinoma — all drugs for Bladder Urothelial Carcinoma →
• Muscle Invasive Bladder Carcinoma — all drugs for Muscle Invasive Bladder Carcinoma →
• Renal Pelvis and Ureter Urothelial Carcinoma — all drugs for Renal Pelvis and Ureter Urothelial Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Bladder Carcinoma or Bladder Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
   Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
2. Targeting cytokine and chemokine signaling pathways for cancer therapy.
   Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
3. Unleashing the potential of combining FGFR inhibitor and immune checkpoint blockade for FGF/FGFR signaling in tumor microenvironment.
   Ruan R, Li L, Li X, Huang C, et al · · 2023 · cited 86× · PMID 36966334 · DOI 10.1186/s12943-023-01761-7
4. FGFR inhibition augments anti-PD-1 efficacy in murine FGFR3-mutant bladder cancer by abrogating immunosuppression.
   Okato A, Utsumi T, Ranieri M, Zheng X, et al · · 2024 · cited 24× · PMID 38226620 · DOI 10.1172/jci169241
5. Treatment approaches for FGFR-altered urothelial carcinoma: targeted therapies and immunotherapy.
   Benjamin DJ, Hsu R. · · 2023 · cited 13× · PMID 37675102 · DOI 10.3389/fimmu.2023.1258388
6. Upper Tract Urothelial Carcinoma: A Rare Malignancy with Distinct Immuno-Genomic Features in the Era of Precision-Based Therapies.
   Evmorfopoulos K, Mitrakas L, Karathanasis A, Zachos I, et al · · 2023 · cited 10× · PMID 37509415 · DOI 10.3390/biomedicines11071775
7. Urinary comprehensive genomic profiling predicts urothelial carcinoma recurrence and identifies responders to intravesical therapy.
   Rac G, Patel HD, James C, Desai S, et al · · 2024 · cited 7× · PMID 37753732 · DOI 10.1002/1878-0261.13530
8. FGFR Inhibitors in Urothelial Cancer: From Scientific Rationale to Clinical Development.
   Kwon WA. · · 2024 · cited 4× · PMID 39536791 · DOI 10.3346/jkms.2024.39.e320