Clinical Trials Using BCG Vaccine

Clinical trials are research studies that involve people. The clinical trials on this list are studying BCG Vaccine. 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 1-7 of 7
  • QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

    This is a Phase II, open-label, single-arm, multicenter study of intravesical BCG plus ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. The study duration is 24 months.
    Location: 13 locations

  • Bacillus Calmette-Guerin (BCG) Vaccine and Gemcitabine for the Treatment of BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer

    This phase I / II trial studies the side effects and best dose of gemcitabine when given together with BCG vaccine and to see how well they work in treating patients with high-grade non-muscle invasive bladder cancer that has come back after previous BCG treatment (BCG-relapsing). Drugs used in chemotherapy, such as 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. BCG vaccine may help the body build an effective immune response to kill tumor cells. Re-treatment with BCG in combination with gemcitabine may be an effective way to treat patients with BCG-relapsing high-grade non-muscle invasive bladder cancer.
    Location: 7 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: 12 locations

  • ADAPT-BLADDER: Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder

    A multi-arm multi-stage (MAMS) phase 1 / 2 study. Phase 1 will be conducted in BCG-unresponsive NMIBC patients to establish the safety of durvalumab monotherapy (cohort 1) and durvalumab in combination with BCG (cohort 2a) and external beam radiation therapy (EBRT) (cohort 2b). Provided safety is demonstrated and recommended phase 2 doses (RP2D) are established in phase 1, the study will proceed to phase 2 testing. Phase 2 will be conducted in the BCG-relapsing or persistent NMIBC population. In phase 2, BCG-relapsing or persistent NMIBC subjects will be randomized between treatment arms examining intravesical BCG in combination with novel immunotherapy agents (durvalumab), novel immunotherapy in combination with radiation (durvalumab + EBRT), or retreatment with intravesical BCG. In addition to providing additional safety data on the combination regimens studied, phase 2 will provide preliminary efficacy profiles for BCG-relapsing or persistent NMIBC subjects with and without CIS treated with each regimen. For regimens demonstrating a tolerable safety profile and encouraging clinical activity in this phase 1 / 2 design, a randomized phase 3 trial of experimental arm therapy versus re-treatment with intravesical BCG therapy would be considered.
    Location: 6 locations

  • Avelumab and Bacille Calmette-Guerin for the Treatment of Recurrent Non-muscle Invasive Bladder Cancer, ABC Study

    This phase I / II trial studies the side effects of avelumab and Bacille Calmette-Guerin (BCG) and how well they work for the treatment of non-muscle invasive bladder cancer that has come back (recurrent). 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. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. BCG is used in a solution to stimulate the immune system in the treatment of bladder cancer. It is unclear whether the addition of avelumab may or may not potentially negate, rather than add to, the treatment effect of BCG alone in recurrent non-muscle invasive bladder cancer.
    Location: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma

  • A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

    A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.
    Location: University of Colorado Hospital, Aurora, Colorado

  • BCG Vaccine for Health Care Workers as Defense Against COVID 19

    SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.
    Location: M D Anderson Cancer Center, Houston, Texas