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 1-25 of 37
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  • 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: 19 locations

  • Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

    This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
    Location: 10 locations

  • Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

    This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).
    Location: 8 locations

  • Durvalumab and Tremelimumab in Treating Patients with Relapsed or Refractory Germ Cell Tumors

    This phase II trial studies how well durvalumab and tremelimumab work in treating patients with germ cell tumors that have returned after a period of improvement (relapsed) or do not respond to treatment (refractory). 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.
    Location: 7 locations

  • Phase 1b / 2 Study of the Combination of IMCgp100 With Durvalumab and / or Tremelimumab in Cutaneous Melanoma

    This study is a Phase Ib / II, multi-center, open-label study of IMCgp100 as a single agent and in combination with durvalumab (MEDI4736) and / or tremelimumab in metastatic cutaneous melanoma. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and to evaluate the anti-tumor activity of IMCgp100 in combination with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent IMCgp100 alone. The study will enroll patients who have metastatic melanoma that is refractory to treatment with an anti-PD-1 inhibitor in the metastatic setting. This study will also evaluate the safety, tolerability, and anti‐tumor activity of IMCgp100 monotherapy in patients with advanced non‐uveal melanoma who progressed on prior PD‐1 inhibitors approved for the treatment of advanced melanoma; patients with BRAF mutations must be refractory to approved BRAF‐based therapy. Recent biologic evidence indicates that optimal responses to programmed cell death-1 (PD-1) directed therapy require the presence of CD8+ T cells in the tumor microenvironment and thus therapies such as IMCgp100 that recruit these effector cells to the tumor may overcome pre-existing resistance to checkpoint blockade. This emerging biology of checkpoint inhibitor resistance suggests the combination of IMCgp100 with checkpoint inhibition may have enhanced activity in patients with pre-existing resistance.
    Location: 7 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

  • Durvalumab and Tremelimumab for Pediatric Malignancies

    The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.
    Location: 5 locations

  • GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors

    The purpose of this study is to evaluate if the combination of GSK3359609 and tremelimumab is safe and tolerable (Part 1) and provides significant survival benefit to subjects with relapsed / refractory (R / R) Head and Neck Squamous Cell Carcinomas (HNSCC) to warrant further clinical investigation (Part 2). Part 1 (dose escalation) will enroll subjects with advanced, selected solid tumors. Subjects will receive escalating doses of GSK3359609 and tremelimumab in combination in Part 1. Part 2 is randomized expansion and will enroll subjects with R / R HNSCC who have disease progression after receiving at least 1 platinum-based chemotherapy and at least 1 anti-programmed death receptor protein-1 (PD-1) / anti-programmed death-ligand 1 (PD-L1) therapy, whether in combination or separately. In Part 2, subjects will be randomized in a ratio of 2:1 to receive either GSK3359609 in combination with tremelimumab at the recommended Phase 2 dose or investigators choice of a single-agent standard of care (SOC) therapy including paclitaxel, docetaxel or cetuximab. The total duration of subjects in the study will be approximately 4 years.
    Location: 5 locations

  • Tremelimumab in Treating Patients with Previously Treated Metastatic Urothelial Cancer

    This phase II trial studies how well tremelimumab works in treating patients with previously treated urothelial cancer that has spread to other places in the body. 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.
    Location: 5 locations

  • A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

    The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.
    Location: 6 locations

  • Durvalumab, Tremelimumab, and Radiation Therapy in Treating Participants with Unresectable, Locally Advanced, or Metastatic Hepatocellular Carcinoma or Biliary Tract Cancer

    This phase II trial studies how well durvalumab, tremelimumab, and radiation therapy work in treating participants with hepatocellular carcinoma or biliary tract cancer that can't be removed via surgery or that has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving durvalumab, tremelimumab, and radiation therapy may work better than radiation therapy alone in treating participants with hepatocellular carcinoma or biliary tract cancer.
    Location: 3 locations

  • Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants with Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers

    This phase I trial studies how well stereotactic body radiation therapy works in combination with tremelimumab and durvalumab in treating participants with cervical, vaginal, or vulvar cancers that have come back (recurrent) or spread to other areas of the body (metastatic). Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. 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. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy, tremelimumab, and durvalumab may work better in treating participants with cervical, vaginal, or vulvar cancers.
    Location: 2 locations

  • Durvalumab, Tremelimumab, and Radiation Therapy in Treating Patients with Gynecologic Cancer That Is Metastatic or Cannot Be Removed by Surgery

    This phase I trial studies the side effects of durvalumab, tremelimumab, and radiation therapy in treating patients with gynecologic cancer that has spread to other places in the body or cannot be removed by surgery. 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 in treating patients with gynecologic cancer.
    Location: 2 locations

  • Durvalumab and Radiation Therapy with or without Tremelimumab in Treating Patients with Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery

    This phase II trials studies the side effects and best dose of durvalumab and radiation therapy with or without tremelimumab in treating patients with stage III non-small cell lung cancer that can be removed by surgery. 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. It is not yet known whether durvalumab and radiation therapy with or without tremelimumab will work better in treating patients with non-small cell lung cancer.
    Location: 2 locations

  • Phase 1 / 2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC

    This is an open-label multicenter 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC. Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 [durvalumab] Arm B: mRNA Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 [tremelimumab] For each arm of the study, there is a dose evaluation phase in which the Recommended Combination Dose (RCD) is determined according to a standard 3 + 3 design. The dose evaluation phase is followed by an expansion phase, in which the cohort at the RCD is expanded to 20 subjects (inclusive of the subjects from the dose evaluation cohort).
    Location: 2 locations

  • Durvalumab and Tremelimumab in Treating Patients with Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    This phase II trial studies how well durvalumab and tremelimumab work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) or does not respond to treatment (refractory). 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. It is not yet known whether give durvalumab and tremelimumab in combination or sequential administration works better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
    Location: 2 locations

  • Olaparib, Durvalumab, and Tremelimumab in Treating Patients with Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer with BRCA1 or BRCA2 Mutation

    This phase I / II trial studies the side effects and best dose of olaparib when give together with durvalumab and tremelimumab and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation that has come back (recurrent) or has not responded to treatment (refractory). Drugs, such as olaparib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and kill tumors cells with BRCA1 or BRCA2 mutation. 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 olaparib with durvalumab and tremelimumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
    Location: 2 locations

  • 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: 2 locations

  • Durvalumab and Tremelimumab in Combination with Platinum-based Chemotherapy for the Treatment of Patients with Untreated Extensive-Stage Small Cell Lung Cancer

    This phase I trial studies how well durvalumab and tremelimumab given in combination with platinum-based chemotherapy work in treating patients with untreated extensive-stage small cell lung cancer. Extensive-stage small cell lung cancer is associated with aggressive biology and poor outcomes. Each study drug, durvalumab and tremelimumab, targets a different signal that may be stopping the body's immune system from killing the cancer. Durvalumab targets a signal on tumor cells and tremelimumab targets a signal on immune cells. It is hoped that by blocking these signals, the immune cells will once again be able to prevent or slow down cancer growth. Chemotherapy drugs such as carboplatin and etoposide, work in 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. The information learned from the combination of immune boosting drugs may be identified as not excessively toxic and may be studied further to determine the benefit of using these as a therapy for extensive-stage small cell lung cancer.
    Location: University of Nebraska Medical Center, Omaha, Nebraska

  • Durvalumab with or without Tremelimumab or Olaparib after Thoracic Radiation Therapy in Treating Patients with Extensive Stage-Small Cell Lung Cancer

    This phase I / Ib trial studies the side effects and how well durvalumab with or without tremelimumab or olaparib works after thoracic radiation therapy in treating patients with extensive stage-small cell lung cancer. 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. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if all / any of the combinations of study treatment following thoracic radiation therapy will improve 6-month progression-free survival compared with a similar historical control group.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Durvalumab and Tremelimumab in Treating Patients with Somatically Hypermutated Recurrent or Refractory Solid Tumors

    This phase II trial studies how well durvalumab works in combination with tremelimumab in treating patients with somatically hypermutated solid tumors that have come back or have not responded to treatment. Somatic hypermutation is a cellular mechanism that happens when the immune system adapts to a new foreign element (e.g. microbes). 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 durvalumab with tremelimumab may work better in treating patients with somatically hypermutated solid tumors compared to standard treatment (chemotherapy, immunotherapy [using your immune system to treat your cancer] with other agents, or palliative care [no treatment]).
    Location: University of Kentucky / Markey Cancer Center, Lexington, Kentucky

  • Durvalumab and Tremelimumab in Treating Patients with Liver Cancer Undergoing Drug-Eluting Bead Transarterial Chemoembolization

    This phase II trial studies how well durvalumab and tremelimumab work in treating patients with liver cancer undergoing drug-eluting bead transarterial chemoembolization. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body’s immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Stereotactic Body Radiation Therapy and Durvalumab with or without Tremelimumab before Surgery in Treating Participants with Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner

    This phase Ib / II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating participants with human papillomavirus positive oropharyngeal squamous cell 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. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery may work better, and cause fewer short and long-term side-effects, in participants with oropharyngeal squamous cell cancer.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Radiation Therapy and Durvalumab with or without Tremelimumab in Treating Participants with Unresectable, Locally Advanced, or Metastatic Bladder Cancer

    This phase II trial studies the side effects and how well radiation therapy and durvalumab with or without tremelimumab work in treating participants with bladder cancer that cannot be removed by surgery, has spread to nearby tissue or lymph nodes, or that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and durvalumab with or without tremelimumab will work better in treating participants with bladder cancer.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Durvalumab, Tremelimumab, and Selumetinib in Treating Patients with Recurrent or Stage IV Non-small Cell Lung Cancer

    This phase I / II trial studies the best dose of selumetinib and how well it works with durvalumab and tremelimumab in treating patients with stage IV non-small cell lung cancer or that has come back (recurrent). 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. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving durvalumab, tremelimumab and selumetinib may work better in treating patients with non-small lung cancer.
    Location: M D Anderson Cancer Center, Houston, Texas


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