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 52
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  • Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

    This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.
    Location: 15 locations

  • A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

    This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.
    Location: 14 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 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. 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: 9 locations

  • Durvalumab with or without Tremelimumab in Treating Patients with Recurrent or Persistent Endometrial Cancer

    This randomized phase II trial studies how well durvalumab with or without tremelimumab works in treating patients with endometrial cancer that has come back after a period of time or remains despite treatment. 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 than durvalumab alone in treating patients with recurrent or persistent endometrial cancer.
    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

  • 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: 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: 4 locations

  • Durvalumab and Tremelimumab in Treating Patients with Metastatic Urinary Tract Cancer

    This phase II trial studies how well durvalumab and tremelimumab work in treating patients with urinary tract cancer that has spread to other places in the body. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.
    Location: 4 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: 3 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

  • Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

    This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
    Location: 3 locations

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

    This phase I / II trial studies the side effects and best dose of tremelimumab when given together with olaparib in treating patients confirmed to carry a breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) germline mutation with ovarian, fallopian tube, or primary peritoneal cancer that has has come back. Tremelimumab is an antibody that may stimulate the immune system to fight cancer. Olaparib may block an enzyme that affects how cancer cells grow and divide. Giving tremelimumab and olaparib may work better in treating BRCA mutation carrier patients with ovarian, fallopian tube, or primary peritoneal cancer.
    Location: 3 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: 2 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: 2 locations

  • Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

    This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors
    Location: 3 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

  • 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

  • Study of Durvalumab and Tremelimumab After Radiation for Microsatellite Stable Metastatic Colorectal Cancer Progressing on Chemotherapy

    This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune system to destroy the cancer cells. In order to learn more about certain characteristics of colorectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, fresh tumor samples from an area where the cancer has spread, and blood samples.
    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 or has not responded to treatment. 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

  • Immune Checkpoint Inhibition (Tremelimumab and / or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

    Background: - Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving very focused beams of radiation to tumors. Researchers think that the drugs being used in this study might work better when combined with SBRT in people with pancreatic cancer. Objective: - To study the safety and effectiveness of MEDI4736 and / or tremelimumab with SBRT. Eligibility: - People 18 and older who have pancreatic cancer that has not responded or to chemotherapy. They must be candidates for radiation but not resection. Design: - Participants will be screened with medical history and physical exam. They will have blood tests. Their tumor will be measured using computerized tomography (CT) or magnetic resonance imaging (MRI). - Participants will have their tumor biopsied with a needle. They will have also have a biopsy after cycle 1. - Participants will get 1 or 2 drugs in combination with the SBRT. - For MEDI4736, the duration of each cycle will be 28-days. Participants will get the drug through an intravenous (IV) infusion twice in each cycle (Days 1 and 15). - For tremelimumab, the duration of the first 6 cycles will each last 28 days. Then the duration of the last 3 cycles will change to 12 weeks. Participants will get the drug through an IV once in each cycle. - All participants will have SBRT. Some will get 1 dose of radiation and some will get 5. CT scans will map their tumor. - Participants will have medical history, physical exam, and blood tests in each cycle. They will have a CT scan or MRI every 8 weeks. Cycles will continue for up to 12 months. - Participants will be contacted yearly for follow-up.
    Location: 2 locations

  • 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

  • Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Patients With Advanced Malignancies

    The clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA 2752 in patients with relapsed / refractory solid tumor malignancies or lymphoma.
    Location: University of Colorado Hospital, Aurora, Colorado

  • 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

  • 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


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