Clinical Trials Using Tremelimumab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Tremelimumab. 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 26-36 of 36

  • Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    This phase I / II trial studies the side effects of durvalumab, tremelimumab and hypofractionated radiation therapy in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving durvalumab, tremelimumab, and hypofractionated radiation therapy may work better in treating patients with recurrent or metastatic head and neck squamous cell carcinoma.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Stereotactic Body Radiation Therapy, Durvalumab, and Tremelimumab in Treating Patients with Stage IV Non-small Cell Lung Cancer

    This phase Ib trial studies the side effects of stereotactic body radiation therapy, durvalumab, and tremelimumab and to see how well they work in treating patients with stage IV non-small cell lung cancer. 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. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy, durvalumab, and tremelimumab may work better in treating patients with non-small cell lung cancer.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • A Phase I / II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer

    Background: - Immune-based approaches in colorectal cancer have unfortunately with the notable exception of immune checkpoint inhibition in microsatellite instable (MSI-hi) disease been largely unsuccessful. The reasons for this are unclear but no doubt relate to the fact that in advanced disease colorectal cancer appears to be less immunogenic, as evidenced by the lack of infiltrating lymphocytes with advancing T stage - Pexa-Vec (JX-594) is a thymidine kinase gene-inactivated oncolytic vaccinia virus engineered for the expression of transgenes encoding human granulocyte- macrophage colony-stimulating factor (GM-CSF) and beta-galactosidase. Apart from the direct oncolytic activity, oncolytic viruses such as Pexa-Vec have been shown to mediate tumor cell death via the induction of innate and adaptive immune responses - Tremelimumab is a fully human monoclonal antibody that binds to CTLA-4 expressed on the surface of activated T lymphocytes and causes inhibition of B7-CTLA-4-mediated downregulation of T-cell activation. Durvalumab is a human monoclonal antibody directed against PD-L1. - The aim of the study is to evaluate whether the anti-tumor immunity induced by Pexa-Vec oncolytic viral therapy can be enhanced by immune checkpoint inhibition. Objective: -To determine the safety, tolerability and feasibility of Pexa-Vec oncolytic virus in combination with immune checkpoint inhibition in patients with refractory metastatic colorectal cancer. Eligibility: - Histologically confirmed metastatic colorectal cancer. - Patients must have progressed on, been intolerant of or refused prior oxaliplatin- and irinotecan-containing, fluorouracil-based, chemotherapeutic regimen and have disease that is not amenable to potentially curative resection. Patients who have a known KRAS wild type tumor must have progressed, been intolerant of or refused cetuximab or panitumumabbased chemotherapy. - Patients tumors must be documented to be microsatellite-stable (MSS) either by genetic analysis or immunohistochemistry OR microsatellite-high with documented disease progression following anti-PD1 / PDL1 therapy. - Patients must have at least one focus of metastatic disease that is amenable to pre- and ontreatment biopsy. - Willingness to undergo mandatory tumor biopsy. Design: -The proposed study is Phase I / II study of Pexa-Vec oncolytic virus at two dose levels in combination with immune checkpoint inhibition in patients with metastatic colorectal cancer.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Durvalumab, Tremelimumab, and Radiation Therapy in Treating Participants with High Risk Soft-Tissue Sarcoma

    This phase I / II trial studies the side effects of durvalumab, tremelimumab, and radiation therapy and to see how well they work in treating participants with high risk soft-tissue sarcoma. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab, tremelimumab, and radiation therapy may work better at treating high risk soft-tissue sarcoma.
    Location: University of Maryland / Greenebaum Cancer Center, Baltimore, Maryland

  • Azacitidine, Durvalumab, and Tremelimumab in Treating Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    This phase Ib trial studies the best dose of azacitidine when given together with durvalumab and tremelimumab in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving azacitidine, durvalumab, and tremelimumab may work better in treating patients with head and neck squamous cell carcinoma.
    Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts

  • A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

    BACKGROUND: - Various tumor ablative procedures and techniques have been shown to result in immunogenic cell death and induction of a peripheral immune response. The term ablative therapies applies to trans-arterial catheter chemoembolization (TACE), radiofrequency ablation (RFA) and cryoablation (CA). - The underlying hypothesis of this study is that the effect of immune checkpoint inhibition can be enhanced by TACE, CA and RFA in patients with advanced hepatocellular carcinoma (HCC) and biliary tract carcinomas (BTC). We have already demonstrated proof of principle as well as safety and feasibility of this approach with anti-CTLA4 therapy. - Based on the concept of PDL1-mediated adaptive resistance and the emerging role of PD1 therapy in HCC, we would like to evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in HCC and BTC. Objectives: - To preliminarily evaluate the 6-month progression free survival (PFS) of combining tremelimumab and durvalumab in patients with advanced HCC (either alone or with cryoablation, TACE or RFA) and in patients with advanced biliary tract carcinoma (BTC) (either alone or with cryoablation or RFA). ELIGIBILITY: - Histologically or cytologically confirmed diagnosis of HCC or biliary tract carcinoma OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of HCC (or biliary tract carcinoma). - Childs-Pugh A / B7 cirrhosis only is allowed. If patient does not have cirrhosis, this limitation does not apply. - Patients must have disease that is not amenable to potentially curative resection, radiofrequency ablation, or liver transplantation. DESIGN: We will evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in cohorts A (HCC; N=40) and B (BTC; N=30). The first N=10 patients in both cohorts will receive tremelimumab and durvalumab only (i.e. No interventional radiologic procedures). - A: Advanced HCC, BCLC# Stage B / C - N= 1st 10 pts: No ablative procedure Cryoablation / RFA / TACE## - Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28 days until EOS### - 40 total: 10 trem+ dur alone; 10 trem+ dur + TACE; 10 trem + dur + RFA; 10 trem + dur + cryo - B: Intra / extra-hepatic cholangiocarcinoma - N= 1st 10 pts: No ablative procedure; RFA / cryoablation - Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28 days until EOS### - 30 total: 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem - BCLC = Barcelona clinic liver cancer staging system - For BCLC stage B patients TACE may be repeated as per standard of care - EOS = End of study treatment or meeting any of the off-treatment or off study criteria.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Durvalumab and Tremelimumab, Oleclumab, or Monalizumab in Treating Patients with Colorectal Cancer with Lung or Liver Metastases That Can Be Removed by Surgery

    This phase I trial studies the side effects and how well durvalumab and tremelimumab, oleclumab, or monalizumab work in treating patients with colorectal cancer that has spread to the lungs or liver (lung or liver metastases) and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as durvalumab, tremelimumab, oleclumab, and monalizumab may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Durvalumab with or without Tremelimumab in Treating Participants with Resectable Malignant Pleural Mesothelioma

    This phase II trial studies how well durvalumab with or without tremelimumab works in treating participants with malignant pleural mesothelioma that can be removed by surgery. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.
    Location: Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center, Houston, Texas

  • Brachytherapy with Durvalumab or Tremelimumab for the Treatment of Patients with Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies

    This phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see whether brachytherapy with durvalumab or tremelimumab works better in treating patients with gynecological malignancies.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Hypofractionated Radiotherapy Followed by Durvalumab with or without Tremelimumab for the Treatment of Liver Cancer after Progression on Prior PD-1 Inhibition

    This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing) after treatment with PD-1 inhibitor immunotherapy. In some patients, cancer cells and immune cells start to express signals that stop the body’s immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer

    This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, 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 durvalumab and tremelimumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.
    Location: See Clinical Trials.gov