Muscle Invasive Bladder Carcinoma Clinical Trial
Official title:
A Pilot Window of Opportunity Trial: FL-101 in Non-Metastatic Muscle Invasive Bladder Cancer
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
This is a pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy. The target recruitment will be 5 evaluable patients, with a possible expansion. Eligible patients will be enrolled to receive two doses of FL-101 prior to RC. FL-101 will be administered intravenously (IV) every two weeks (i.e., on Day 1 and Day 15). Safety will be assessed by monitoring and recording all TEAEs graded by the NCI CTCAE v.5.0. In addition, laboratory assessments (hematology, serum chemistry, coagulation, and urinalysis), vital signs, physical exams, and 12-lead electrocardiogram (ECG) findings will be used to evaluate the safety of FL-101. The PK of FL-101 will be characterized by analyzing samples collected at the time points. To assess the immunogenicity of FL-101, ADAs will be measured as indicated in the Schedule of Assessments. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06074484 -
A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
|
Phase 2 | |
| Withdrawn |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 |
NCT04383743 -
Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer
|
Phase 2 | |
| Recruiting |
NCT05297552 -
A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
|
Phase 2 | |
| Recruiting |
NCT03775265 -
Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
|
Phase 3 | |
| Recruiting |
NCT05581589 -
Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06263153 -
Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
|
Phase 2 | |
| Recruiting |
NCT05406713 -
Pembrolizumab in Muscle-invasive Bladder Cancer
|
Phase 2 | |
| Terminated |
NCT02145390 -
Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy
|
N/A | |
| Recruiting |
NCT06040762 -
A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial
|
N/A | |
| Not yet recruiting |
NCT06290687 -
Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
|
Phase 2 |