UroGen (UGN) -102 (mitomycin) for intravesical solution
(NMIBC Intermediate Risk)
Status: Active, Not Recruiting
This is a research study to evaluate the effectiveness and safety of a drug called UGN-102 FOR PATIENTS WITH NON muscle-invasive bladder cancer (NMIBC) Mitomycin is a type of chemotherapy that is approved by the US Food and drug Administration (FDA) for treating other types of cancers and is commercially available for the treatment of bladder cancer. UGN-102 (a combination of mitomycin and gel) has not been approved by the FDA or other regulatory agencies and is not commercially available. The purpose of this study is to evaluate the effectiveness and safety of UGN-102, an investigational gel which serves as a reservoir for prolonged drug exposure of a type of chemotherapy (mitomycin C or mitomycin)
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer (B8011006 CREST)
(NMIBC High Risk, BCG Naïve)
Status: Active, Not Recruiting
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) on people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).
SWOG- S1602
(NMIBC High Risk, BCG Naïve)
Status: Active, Not Recruiting
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.
SunRISe-3
(NMIBC High Risk, BCG Naïve)
Status: Active, Recruiting
This is a global multicenter, open-label, randomized Phase 3 study comparing the efficacy of an intravesical drug delivery system in combination with a systemic PD-1 inhibitor versus intravesical Bacillus Calmette-Guerin (BCG) in participants with BCG-naive high-risk non- muscle invasive bladder cancer (HR-NMIBC); high risk is defined as high-grade papillary Ta or T1, or carcinoma in-situ (CIS). Participants will be randomly assigned (1:1) to the 2 treatment groups. Study comparator BCG will be provided by the Sponsor. Screening must start within 12 weeks after a diagnostic transurethral resection of the bladder tumor. An intravesical drug delivery system regulated as an investigational drug since the primary mode of action is the drug constituent, gemcitabine. Each intravesical delivery system provides a continuous release of gemcitabine into the bladder urine, with the majority being delivered within the first 7 days.The primary hypothesis of this study is that treatment with a local intravesical drug delivery system in combination with a systemic PD-1 inhibitor in participants with HR-NMIBC who are BCG naïve will result in prolonged event-free survival (EFS) as compared to participants treated with intravesical BCG alone. The study drugs and study comparator will be administered throughout the study at a specified dose, interval, and duration under the supervision of the investigator or a qualified member of the study-site personnel.
BRIDGE
(NMIBC High Risk, BCG Naïve)
Status: Active, Recruiting
The usual approach for patients with high-risk, non-muscle invasive bladder cancer (HR-NMIBC) is treatment with Transurethral surgery of bladder tumor (TURBT) followed by instillations of Bacillus Calmette-Guerin (BCG) immunotherapy into the bladder via a catheter. The purpose of this study is to compare the usual treatment (BCG) to using gemcitabine + docetaxel in order to assess whether the treatments are similar in preventing recurrence of bladder cancer. Subjects will be randomly assigned to one of two treatment groups.
Both groups will receive the study drug through a catheter directly into the bladder weekly for 6 weeks. Subjects that show a response to this induction therapy will proceed to maintenance treatment. Group 1 will be treated with gemcitabine and docetaxel monthly for 2 years as a maintenance therapy. Group 2 will be treated with maintenance BCG therapy once a week for 3 weeks in a row at months 3,6,12,18,24,30, and 36 months after the initial BCG treatment begins.
Patients will be followed on study for 5 years after randomization. White light cystoscopic evaluation of the bladder is the gold standard for bladder cancer surveillance in non-muscle invasive bladder cancer, and is the primary tool utilized to assess therapeutic response. The post-treatment tumor response will be determined based on the bladder biopsy results and urine cytology results obtained during post-treatment tumor assessments.
LEGEND- Cohort 1
(NMIBC High Risk, BCG Unresponsive)
Status: Active, Recruiting
Study EG-70-101 is a Phase 1/2, open-label, multicenter, safety and dose-finding study to determine the safety, tolerability, and efficacy of EG-70 in adult patients with NMIBC who have failed BCG therapy and are recommended for radical cystectomy or high-risk NMIBC patients who are BCG-naïve or have received incomplete BCG treatment. The study consists of two phases, a Dose-Escalation Phase (Phase 1), followed by a Phase 2 study at the RP2D and an Efficacy Expansion of the Phase 2 study. All patients in Phase 1 will receive one cycle of treatment with EG-70. Cycles will be 12 weeks in duration. Those patients who have a stable disease (SD) or complete response (CR) at the end of Cycle 1 (Week 10) may continue on treatment for up to a total of 4 cycles provided they do not have progressive disease (PD) or lose their CR based on evaluation for response at the end of each cycle. Patients who complete all 4 cycles without PD Will be followed until PD or for 2 years following their End-of-Treatment Visit (whichever occurs first).
KEYNOTE-057
(NMBIC, High Risk, BCG Unresponsive)
Status: Active, Recruiting
Subjects will participate in the trial from the time the subject provides documented informed consent through the final contact. After a screening phase of approximately 28 days, subjects in Cohorts A and B will receive pembrolizumab, and subjects in Cohort C Arm 1 will receive MK-7684A and Arm 2 will receive MK-4280A.
Subjects will be treated with pembrolizumab, MK-7684A, or MK-4280A for up to 35 administrations (approximately 2 years). Subjects who complete study treatment will continue into the posttreatment tumor assessment period for an additional 3 years. The final evaluation in the tumor assessment period of 5 years will be Week 264. The total duration of the study is estimated to be approximately 14 years.
Subjects who do not complete up to 35 administrations (approximately 2 years) of study treatment and discontinue for reasons other than pathology-confirmed persistent high-risk disease, high-risk recurrence, or disease progression will continue to have posttreatment tumor assessments until disease progression is documented, initiation of a non-study cancer treatment, withdrawal of consent, becomes lost to follow-up, or follow-up for a maximum of 5 years, whichever occurs first.
Subjects who discontinue study treatment for pathology-confirmed persistent high-risk disease, high-risk recurrence, or disease progression will not continue to have study defined posttreatment tumor assessments and will instead enter Survival Follow-up.
All participants will be followed for overall survival and bladder status until death, withdrawal of consent, or the end of the study
SENTINEL-1
(MIBC)
Status: Active, Recruiting
This research study aims to find out if we can safely administer a drug called Hexaminolevulinate (HCl) dye and look for possible cancer spread in the abdomen using blue light. Currently, Hexaminolevulinate (HCl) is used to look at the main bladder tumor during surgery, because it makes bladder cancer cells appear pink under blue light. The standard of care therapy for muscle-invasive bladder cancer (MIBC) is radical cystectomy to remove the bladder, followed by pelvic lymph node dissection to remove possible areas of cancer spread to the lymph nodes. In this study, we want to see if any of the lymph nodes appear to contain cancer under blue light before we remove them during surgery.
Keynote-B15
(MIBC Cisplatin Eligible)
Status: Active, Recruiting
This trial is testing enfortumab vedotin (EV) + pembrolizumab (pembro) given before and after surgery in people with muscle-invasive bladder cancer (MIBC). Pembro has been approved alone or with other drugs for certain cancers. Pembro in combination with other drugs has not been approved for people with bladder cancer. EV has been approved in the USA only for people with bladder cancer. Getting pembro with EV before and after surgery for MIBC is considered experimental.
RAD-VACCINE MIBC
(MIBC Cisplatin Ineligible)
Status: Active, Recruiting
The purpose of this research is to determine if we can safely treat muscle-invasive bladder cancer with SASNLIMAB (also known as PF-06801591) and radiation therapy in combination. The standard of care therapy for most muscle-invasive bladder cancers (MIBC) is to administer chemotherapy before RC. However, chemotherapy is not recommended for certain patients, mainly due to pre-existing medical conditions like poor kidney function. If you are ineligible to receive chemotherapy or do not wish to, then you will be considered for this clinical trial. During this clinical trial, we will see if giving the study drug and radiation therapy works better than surgery alone.