Clinical Trials Using Rilimogene Galvacirepvec

Clinical trials are research studies that involve people. The clinical trials on this list are studying Rilimogene Galvacirepvec. 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 1-5 of 5
  • Prostvac in Patients With Biochemically Recurrent Prostate Cancer

    Background: Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer. Objective: To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone. Eligibility: Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Bone scan CT scan, or MRI and PET scan: They lie in a machine that takes pictures of the body. Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals. Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months. During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months. Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests. Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.
    Location: 2 locations

  • DNA Vaccine, Nivolumab, Ipilimumab, and PROSTVAC in Treating Participants with Metastatic Hormone Sensitive-Prostate Cancer

    This phase I trial studies the side effects and how well deoxyribonucleic acid (DNA) vector pPRA-PSM vaccine (DNA vaccines), nivolumab, ipilimumab, and rilimogene galvacirepvec / recombinant fowlpox-PSA(L155) / TRICOM vaccine (PROSTVAC) work in treating participants with prostate cancer that has spread to other places in the boday and that responds to hormone treatment. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells that express prostate 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. Vaccines like PROSTVAC made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving DNA vaccine, nivolumab, ipilimumab, and PROSTVAC may work better at treating hormone-sensitive prostate cancer.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Combination Immunotherapy in Biochemically Recurrent Prostate Cancer

    Background: Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people. Objective: To see if the combination treatment of PROSTVAC, CV301, and MSB0011359C (M7824) can induce an anti-tumor attack in people with biochemically recurrent prostate cancer. Eligibility: People ages 18 and older with certain kinds of prostate cancer Design: Participants will be screened with - Medical history - Physical exam - Blood and urine tests - A scan of the neck, chest, abdomen, and pelvis - A bone scan A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status. Some participants will have close monitoring with four monthly PSA checks. All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after. Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans. Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer

    Background: Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body. This is called androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They think this may work better against prostate cancer than ADT alone. Objective: To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than ADT alone. Eligibility: Men ages 18 years and over with metastatic castrate-sensitive prostate cancer Design: Participants will be screened with: Physical exam Medical history Blood tests Possible CT, MRI, or bone scan: Participants lie in a machine. The machine takes pictures of the body. Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals. Participants will have 2 optional tumor biopsies during the study. Participants will join 1 of 2 groups. Both groups will get: ADT Docetaxel by vein Steroids by mouth or vein before each docetaxel infusion PROSTVAC injection Both groups first have ADT. One to 4 months after, they have: Group A: Docetaxel every 3 weeks for 6 cycles PROSTVAC 3 weeks after the last infusion Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total Group B: PROSTVAC Booster 2 weeks later Docetaxel hours later Docetaxel and the booster every 3 weeks for 6 cycles Participants will have a visit 4-5 weeks after the last treatment. They will then have visits every 12 weeks. Participants will be followed for up to 15 years. This includes physical exams every year for 5 years.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Rilimogene Galvacirepvec and Recombinant Fowlpox-PSA(L155) / TRICOM Vaccine in Preventing Relapse in Patients with Prostate Cancer after Radical Prostatectomy

    This phase II trial studies how well rilimogene galvacirepvec and recombinant fowlpox-prostate specific antigen (PSA)(L155) / triad of costimulatory molecules (B7-1, ICAM-1 and LFA-3) (TRICOM) vaccine work in preventing prostate cancer from coming back in patients who have undergone radical prostatectomy. Vaccines made from a gene-modified virus such as, rilimogene galvacirepvec and recombinant fowlpox-PSA(L155) / TRICOM vaccine, may help the body build an effective immune response to kill tumor cells. Giving vaccine after surgery may kill any remaining tumor cells.
    Location: 2 locations