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 26-32 of 32

  • 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 in Treating Patients with Metastatic HER2 Negative Breast Cancer

    The main purpose of this study is to determine the anti-tumor activity of durvalumab in combination with tremelimumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called cytotoxic T lymphocyte associated 4 (CTLA-4) on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.
    Location: Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois

  • Durvalumab and Tremelimumab after Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer

    This phase Ib trial investigates the side effects of durvalumab and tremelimumab after radioembolization (radiation particles against liver tumors) and to see how well they work in treating patients with liver cancer that cannot be removed by surgery (unresectable) and has spread to nearby tissues and lymph nodes (locally advanced). Durvalumab and tremelimumab are antibodies (proteins produced by the defense system of the body [immune system]) that have been made in the laboratory and may improve the ability of the immune system to detect and fight cancer.
    Location: City of Hope Comprehensive Cancer Center, Duarte, 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: University of California San Francisco, San Francisco, California

  • Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer

    This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as 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 olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer.
    Location: 20 locations

  • 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