Bladder Urothelial Carcinoma Clinical Trial
Official title:
A Phase II Trial of Futibatinib in Combination With Durvalumab Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy
This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.
PRIMARY OBJECTIVE: I. Determine the pathologic complete response rate of neoadjuvant futibatinib and durvalumab combination in patients with MIBC and fibroblast growth factor receptor (FGFR) overexpression. SECONDARY OBJECTIVES: I. Determine the safety of this neoadjuvant regimen. II. Assess the pathologic downstaging rate. III. Evaluate overall survival (OS) and progression free survival (PFS). IV. Evaluate delay in cystectomy. EXPLORATORY OBJECTIVES: I. Evaluate potential predictive biomarkers. II. Assess changes in the tumor microenvironment in pre- and post-treatment tumor samples in participants. OUTLINE: Patients receive futibatinib orally (PO) once daily (QD) on days 1-28 and durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo radical cystectomy within 4-12 weeks. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) during screening and on the trial and also undergo blood sample collection on the trial. After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 2 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03039413 -
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
|
Early Phase 1 | |
| Active, not recruiting |
NCT03601455 -
Radiation Therapy and Durvalumab With or Without Tremelimumab in Treating Participants With Unresectable, Locally Advanced, or Metastatic Bladder Cancer
|
Phase 2 | |
| Completed |
NCT02989064 -
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers
|
Phase 1 | |
| Terminated |
NCT00072137 -
Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
|
Phase 1 | |
| Withdrawn |
NCT05564416 -
Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial
|
Phase 2 | |
| Recruiting |
NCT04570410 -
Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma
|
Phase 2 | |
| Recruiting |
NCT06167356 -
Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.
|
||
| Terminated |
NCT05052372 -
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
|
||
| Terminated |
NCT03266900 -
A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
|
Early Phase 1 | |
| Terminated |
NCT05012397 -
Milademetan in Advanced/Metastatic Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03473730 -
Daratumumab in Treating Patients With Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer
|
Early Phase 1 | |
| Active, not recruiting |
NCT03138824 -
Storz Professional Image Enhancement System Versus White Light Imaging Assisted TURBT for Treatment of NMIBC
|
N/A | |
| Recruiting |
NCT05788484 -
A Study of CDX-585 in Patients With Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05669430 -
A Study of GV20-0251 in Patients With Solid Tumor Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT04216290 -
A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes (The INSPIRE Study)
|
Phase 2 | |
| Recruiting |
NCT03775265 -
Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
|
Phase 3 | |
| Completed |
NCT00238420 -
Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02496208 -
Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors
|
Phase 1 | |
| Recruiting |
NCT04985604 -
Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04129606 -
Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy
|
N/A |