Treatment Clinical Trials for Bladder Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for bladder cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 126-142 of 142
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  • A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer

    The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for Instillation (VAX014) in patients with low-grade Non-Muscle Invasive Bladder Cancer (NMIBC). VAX014 is a targeted oncolytic agent designed to kill tumor cells following instillation into the urinary bladder.
    Location: University of Iowa / Holden Comprehensive Cancer Center, Iowa City, Iowa

  • Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non-Muscle Invasive Bladder Cancer

    This is a single-arm, phase 1 / 2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder. Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established). Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (uni-or multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study. May meet definition of low grade without histological tissue diagnosis if on cystoscopic assessment they have a solitary papillary tumor. Part 3 of the study will continue to track subjects enrolled in Parts 1 and 2 to determine rates of disease-free survival.
    Location: See Clinical Trials.gov

  • Tesetaxel for Previously Treated Patients With Bladder Cancer

    The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients. Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.
    Location: See Clinical Trials.gov

  • Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Na(SqrRoot) ve and Refractory Subjects With Urothelial Carcinoma

    Background: Metastatic urothelial carcinoma is lethal and has no cure. Response rates to current treatments are modest. Researchers want to find new strategies to treat the disease. In this study, they will test a drug called M7824. The drug is a new immunotherapy that blocks the pathways that cancer cells use to stop the immune system from fighting cancer. Objective: To learn if M7824 can help the immune system s ability to fight urothelial cancer. Eligibility: People age 18 and older who have urothelial cancer that has spread to other parts of their body and they have been previously treated with chemotherapy or immunotherapy Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests. They will have imaging scans. They will have an electrocardiogram to measure heart function. Their ability to perform their normal activities will be evaluated. They may have a tumor biopsy. They will take a pregnancy test if needed. Participants will repeat some of the screening tests during the study. Treatment will be given in a series of 28-day cycles. Participants will get M7824 once every 2 weeks. It is given through an intravenous infusion. For this, a small plastic tube is put into an arm vein. They will get M7824 until their disease gets worse, they have unacceptable side effects, or they decide to stop treatment. Participants will have a follow-up visit 30 days after treatment ends. Then they will be followed every 12 weeks in the clinic or by telephone / email. Follow-up will last indefinitely.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Pembrolizumab and Combination Chemotherapy before Surgery for the Treatment of Muscle-Invasive Bladder Cancer

    This pilot study is evaluating how well pembrolizumab and combination chemotherapy before surgery work for the treatment of specific types of muscle-invasive bladder cancer that have unusual appearance (variants). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, adriamycin, and cisplatin 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. Giving pembrolizumab and combination chemotherapy before surgery may work better in treating patients with these muscle invasive bladder cancer variants compared to chemotherapy alone.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Vaccine Response With NT-I7

    Background: People with cancer, and especially older people, have a weakened immune system (the defense system of the body). This is often caused by the treatments for cancer. Older cancer survivors are therefore more prone to getting infections, some of which are preventable through vaccines. But because their immune systems are weakened, their response to vaccines is poor. Researchers want to see if a new drug, NT-17, can help. Objective: To see if NT-I7 can boost the immune system. Eligibility: Adults 60 and older who have recently finished chemotherapy for breast, colorectal, or bladder cancer. Design: Participants will be screened with a physical exam, medical history, and blood and urine samples. Their heart s electrical activity will be checked. They will have an ultrasound of their spleen. They may give a tissue sample from a previous biopsy. Participants in phase 1a of the study will get 1 dose of NT-I7. It will be given by injection with a needle into the muscle of the upper arm, thigh, or buttocks. Participants in phase 1b will get 5 vaccines over a few months. They may get an optional booster and / or 6th vaccine. They will also get NT-17. Participants will repeat the screening tests during the study. They may get a peripheral intravenous catheter in a vein in their hand or arm for blood draws. Participants may have apheresis. For this, blood is taken from an arm vein. The white blood cells are separated from the blood. The rest of the blood, minus the white blood cells, is returned into a vein in the other arm. A catheter may be used. Participants will have follow-up visits for 1 year.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer

    The purpose of this study is to evaluate bintrafusp alfa in participants with metastatic or locally advanced urothelial cancer. This trial provides the first evaluation of bintrafusp alfa in participants with urothelial cancer that has progressed following platinum therapy
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

    This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a CR with anti-PD-1 / PD-L1 based regimens
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • sEphB4-HSA in Treating Participants with BCG-Unresponsive or Refractory Bladder Cancer

    This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein (sEphB4-HSA), and to see how well it works in treating participants with bladder cancer that has come back or that isn't responding to bacillus Calmette-Guerin (BCG) vaccine treatment. sEphB4-HAS prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. Giving sEphB4-HSA may work better in treating participants with bladder cancer.
    Location: USC / Norris Comprehensive Cancer Center, Los Angeles, California

  • AGEN1884 and AGEN2034 in Combination with Cisplatin and Gemcitabine for the Treatment of Muscle-invasive Bladder Cancer before Radical Cystectomy

    This phase II trial investigates how well AGEN1884 and AGEN2034 work in combination with cisplatin and gemcitabine in treating patients with muscle-invasive bladder cancer before surgery that removes all of the bladder as well as nearby tissues and organs (radical cystectomy). AGEN1884 (a CTLA-4 blocking agent) and AGEN2034 (a PD-1 blocking agent) are a class of drugs called immune checkpoint inhibitors that may help the body's immune system attack the cancer and interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin and gemcitabine, 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 treatment of muscle-invasive bladder cancer is chemotherapy followed by surgery and a cystectomy. Adding AGEN1884 and AGEN2034 to this standard treatment may improve the rate of the bladder cancer coming back.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

  • Encapsulated Rapamycin for the Treatment of Non-Muscle Invasive Bladder Cancer

    This phase II trial investigates how well encapsulated rapamycin works in treating patients with bladder cancer. Rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to see if encapsulated rapamycin may decrease the risk of cancer coming back (relapse) in patients with non-muscle invasive bladder cancer, and to learn if encapsulated rapamycin may help improve cognition and physical function without negatively affecting patient-reported outcomes and quality of life.
    Location: 2 locations

  • 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

    This phase II trial studies how well chemotherapy and radiation therapy alone works compared to chemotherapy and radiation therapy plus MEDI4736 (durvalumab) immunotherapy in treating bladder cancer which has spread to the lymph nodes. Drugs used in standard chemotherapy 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with durvalumab may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy and radiation therapy with the addition of durvalumab may work better in helping tumors respond to treatment compared to chemotherapy and radiation therapy alone.
    Location: Location information is not yet available.

  • Durvalumab with or without Oleclumab before Surgery in Treating Patients with Bladder Urothelial Carcinoma

    This phase I trial studies how well durvalumab with or without oleclumab works in treating patients with bladder urothelial carcinoma when given before standard of care surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and oleclumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 3 locations

  • Avelumab and Docetaxel in Treating Patients with Platinum Refractory or Ineligible Metastatic Urothelial Cancer

    This phase Ib trial studies the best dose of avelumab and how well it works when given together with docetaxel in treating patients with urothelial cancer that has spread to other places in the body and does not respond to platinum chemotherapy or cannot receive platinum chemotherapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as docetaxel, 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. Giving avelumab and docetaxel may work better in treating patients with locally advanced or metastatic urothelial cancer.
    Location: University of Iowa / Holden Comprehensive Cancer Center, Iowa City, Iowa

  • Atezolizumab with or without Eribulin Mesylate in Treating Patients with Recurrent Locally Advanced or Metastatic Urothelial Cancer

    This phase II trial studies the side effects of atezolizumab with or without eribulin mesylate and how well they work in treating patients with urothelial cancer that has come back, spread to nearby tissues and lymph nodes, or other places in the body. 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. Drugs used in chemotherapy, such as eribulin mesylate, 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. Giving atezolizumab and eribulin mesylate may work better at treating urothelial cancer.
    Location: 7 locations

  • Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

    This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.
    Location: 332 locations

  • Atezolizumab and Guadecitabine in Treating Patients with Advanced or Metastatic Urothelial Cancer

    This phase II trial studies the side effects and best dose of atezolizumab and guadecitabine and how well they work in treating patients with urothelial cancer that has spread to other places in the body. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Guadecitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and guadecitabine together may work betting in treating patients with urothelial cancer.
    Location: 3 locations


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