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A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer (ADVANCED-2)
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: -Participants with CIS (± Ta/T1) who are BCG naive, or -Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: -Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)
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A Study Of Intravesical Bacillus Calmette-Guerin (BCG) In Combination With ALT-803 (N-803) In Patients With Non-Muscle Invasive Bladder Cancer
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
For Cohort A, the purpose of this study is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with CIS disease (with or without Ta/T1) in terms of complete response (CR) rate using cystoscopy, confirmatory bladder biopsy, and urine cytology. For Cohort B, the purpose is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with high-grade papillary disease (Ta/T1 only) in terms of disease-free survival (DFS) using cystoscopy, confirmatory bladder biopsy, and urine cytology.
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ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (ABLE-41)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to collect data on the early use of ADSTILADRIN. Data will be collected from participants, caregivers and prescribing physicians in a real-world setting.
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MC240502: Cancer CARE (Connected Access And Remote Expertise) Beyond Walls In-home INtraVesIcal ThErapy (INVITE) Study - A Phase Ib/II, Single-Arm Trial Of Delivering Intravesical Therapy For Bladder Cancer In Patients' Homes
Jacksonville, Fla.
This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.
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A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
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GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone For Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (GAIN-BCG)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.
Closed for Enrollment
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A PhAse 1a/b, Dose finding, open-label study to eValuate sAfety and toxicity, of iNtravesiCal
instillation of TARA-002 in adults with high-gradE non-muscle invasive blaDder cancer (ADVANCED-1)
Rochester, Minn.,
Jacksonville, Fla.
The primary objective of this study is to characterize the safety and toxicity profile of TARA-002 administered intravesically.
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A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy (SunRISe-4)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with cetrelimab and cetrelimab alone.
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A Phase 3, Randomized Study Of Adjuvant Cretostimogene Grenadenorepvec Versus Observation For The Treatment Of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection Of Bladder Tumor (TURBT)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
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An Open-Label, Single Arm, Phase II Study of Intraoperative GEMcitabine INtravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma
Rochester, Minn.,
Jacksonville, Fla.
The primary purpose of this study is to assess the effectiveness of a single intraoperative intravesical instillation of gemcitabine at time of radical nephroureterectomy (RNU) to prevent intravesical recurrence of urothelial carcinoma (UC) at 1 year in patients with clinically localized upper tract urothelial carcinoma (UTUC).
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CG3002S, A Phase 3 Study of Cretostimogene Grenadenorepvec in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) (BOND-003)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the activity of intravesical (IVE) administration of Cretostimogene Grenadenorepvec in patients with tissue pathology confirmed non-muscule invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease.
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Exploring MRI for Local Staging in Bladder Cancer
Jacksonville, Fla.
The purposes of this study are to assess image quality of a multiparametric MRI protocol for local staging imaging among patients with bladder cancer, and to assess accuracy of MR imaging in determining muscle invasion.
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MK-3475-676, A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is either Persistent or Recurrent Following BCG Induction or that is Naïve to BCG Treatment (KEYNOTE-676) (KEYNOTE-676)
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction or that is naïve to BCG treatment.
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Qualitative Research with Bladder Cancer Patients: What are Largest Patient-Reported Barriers in Radical Cystectomy Care? (QualBC)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to explore thoughts and experiences of bladder cancer patients who underwent radical cystectomy at Mayo Clinic Florida through qualitative interviews.
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S1600, A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes (SIMmune)
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to evaluate how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
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Sexual Function in Women Undergoing Radical Cystectomy
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary purpose of this study is to characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.
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