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 26-50 of 149

  • First Time in Humans (FTIH) Study of GSK3368715 in Subjects With Solid Tumors and Diffuse Large B-cell Lymphoma (DLBCL)

    Arginine methylation mediated by protein arginine methyl-transferases (PRMTs) is an important post-translational modification of proteins involved in a diverse range of cellular processes. Misregulation and overexpression of PRMT1 (a type I PRMT) has been associated with a number of solid and hematopoietic cancers. GSK3368715 leads to inhibition of tumor cell growth across tumor types with cytotoxic response observed in lymphoma, acute myeloid leukemia (AML) and a subset of solid tumor cell lines. This study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK33368715 in subjects with relapsed / refractory DLBCL and selected solid tumors with frequent methyl-thioadenosine phosphorylase (MTAP)-deficiency. The study will consist of two parts. In Part 1 (Dose Escalation) escalating doses of GSK3368715 will be evaluated and recommended phase 2 dose (RP2D) will be established in subjects with selected solid relapsed / refractory tumors. In Part 2 (Dose Expansion), this RP2D will be further investigated in two expansion cohorts; subjects with DLBCL (Expansion Cohort 2A) and relapsed / refractory solid tumors including pancreatic, bladder, and non-small cell lung cancer (NSCLC)(Expansion Cohort 2B). The study includes a screening period, an intervention period and follow up. Approximately 40 subjects will be enrolled in Part 1 and 141 will be enrolled in Part 2.
    Location: 9 locations

  • A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder

    A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer
    Location: 10 locations

  • A Study of RO7198457 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

    This is a Phase 1a / 1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of RO7198457 as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).
    Location: 13 locations

  • Atezolizumab, Gemcitabine Hydrochloride, and Cisplatin as First-Line Therapy in Treating Patients with Locally Advanced or Metastatic Urothelial Cancer

    This randomized phase II trial studies how well atezolizumab works when given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating patients with urothelial cancer that has spread to nearby tissue or 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 gemcitabine hydrochloride 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 atezolizumab with chemotherapy may kill more tumor cells.
    Location: 8 locations

  • Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced / Metastatic Solid Tumors

    This study is an open-label Phase 1 / Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced / metastatic solid tumors.
    Location: 8 locations

  • Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057 / KEYNOTE-057)

    In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.
    Location: 8 locations

  • Stereotactic Body Radiation Therapy in Treating Patients with Metastatic Cancer with Limited Progression on Immune Checkpoint Inhibitors

    This phase II trial studies how well stereotactic body radiation therapy works in treating patients with cancer that has spread to other places in the body with limited progression while on immune checkpoint blockade. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
    Location: 7 locations

  • Atezolizumab and CYT107 in Treating Participants with Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma

    This phase II trial studies how well atezolizumab when given with glycosylated recombinant human interleukin-7 (CYT107) works in treating participants with urothelial carcinoma that has spread to nearby tissue or lymph nodes, cannot be removed by surgery, or 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. CYT107 is a biological product naturally made by the body that may stimulate the immune system to destroy tumor cells. Giving atezolizumab and CYT107 may work better in treating participants with locally advanced, inoperable, or metastatic urothelial carcinoma.
    Location: 7 locations

  • A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

    The purpose of this study is to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study will also compare progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study will evaluate the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assess the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.
    Location: 7 locations

  • Nivolumab and Ipilimumab in Treating Patients with Advanced Rare Genitourinary Tumors

    This phase II trial studies how well nivolumab and ipilimumab work in treating patients with rare genitourinary tumors that have spread to other anatomic sites or is no longer responding to treatment. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 7 locations

  • PRS-343 in HER2-Positive Solid Tumors

    A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
    Location: 7 locations

  • Atezolizumab and Bevacizumab in Previously Untreated Metastatic / Unresectable Urothelial Cancer

    This phase II trial studies how well atezolizumab and bevacizumab works in treating patients with urothelial cancer that has spread to other places in the body or that cannot be removed by surgery and are ineligible for cisplatin. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 7 locations

  • MAGE-A4ᶜ¹º³²T for Multi-Tumor

    This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid / round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors.
    Location: 8 locations

  • A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

    The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF / FGFR alterations.
    Location: 8 locations

  • Phase Ib Feasibility Trial of Neoadjuvant Nivolumab / Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

    Patients with muscle-invasive bladder cancer (MIBC) who can not receive cisplatin or refuse cisplatin therapy will receive nivolumab or nivolumab / lirilumab before a planned surgical procedure called a radical cystectomy (RC) to remove the bladder. Nivolumab works by attaching to and blocking a molecule called Programmed Death-1 (PD-1). Lirilumab attaches to and blocks a group of molecules called Killer Cell Immunoglobulin-Like Receptor (KIR). PD-1 and KIR are proteins present mainly on immune system cells, and each controls part of the immune system by shutting it down. It is hoped that by binding to and inactivating these proteins, these drugs can enhance the body's ability to detect, attack and destroy cancer cells. The purpose of this research study is to see whether nivolumab alone or combination of nivolumab and lirilumab given before surgery is effective in treating people who have bladder cancer, and to examine the side effects, good and bad, associated with nivolumab and lirilumab.
    Location: 7 locations

  • Nivolumab with or without Ipilimumab before Surgery in Treating Patients with Muscle Invasive Bladder Cancer

    This phase II trial studies how well nivolumab works with or without ipilimumab before surgery in treating patients with muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab and ipilimumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: 6 locations

  • Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors

    The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype. The secondary objectives of this study are to characterize the pharmacokinetics (PK) of rogaratinib and copanlisib alone and in combination, and to assess the anti-tumor efficacy of rogaratinib in combination with copanlisib for locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.
    Location: 7 locations

  • Gemcitabine Hydrochloride and Nivolumab with Carboplatin or Oxaliplatin in Treating Patients with Locally Advanced or Metastatic Urothelial Cancer

    This phase II trial studies how well gemcitabine hydrochloride and nivolumab with carboplatin or oxaliplatin work in treating patients with urothelial cancer that has spread from its original site of growth to nearby tissues or lymph nodes or that has spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, and oxaliplatin, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and nivolumab with carboplatin or oxaliplatin may work better in treating patients with urothelial cancer.
    Location: 6 locations

  • Dose Escalation and Expansion Study of GSK3359609 in Subjects With Selected Advanced Solid Tumors (INDUCE-1)

    GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.
    Location: 6 locations

  • A Phase 1 / 2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers

    This is an open-label, multicenter Phase 1 / 2 study of the CTLA-4 antibody, tremelimumab, and the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers.
    Location: 6 locations

  • An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

    The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
    Location: 6 locations

  • Durvalumab+ Gemcitabine / Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

    A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
    Location: 6 locations

  • Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676 / KEYNOTE-676)

    This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is persistent or recurrent following adequate BCG induction. The primary hypothesis is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS).
    Location: 7 locations

  • Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Subjects With Resected Solid Tumors and in Combination With Pembrolizumab in Subjects With Unresectable Solid Tumors

    The purpose of this study is to assess the safety, tolerability and immunogenicity of mRNA-4157 alone in subjects with resected solid tumors, and in combination with pembrolizumab in subjects with unresectable solid tumors.
    Location: 5 locations

  • Recombinant EphB4-HSA Fusion Protein and Pembrolizumab in Treating Patients with Metastatic or Recurrent Urothelial Cancer That Is Refractory to Certain Chemotherapy Drugs

    This phase II trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab work in treating patients with urothelial (bladder) cancer that has spread from the primary site to other places in the body or has come back and does not respond to certain chemotherapy drugs. Combinations of biological substances in recombinant EphB4-HSA fusion protein may be able to carry tumor-killing substances directly to urothelial cancer cells. 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. Giving recombinant EphB4-HSA fusion protein and pembrolizumab together may be a better treatment for patients with urothelial cancer.
    Location: 5 locations