Clinical Trials Using Durvalumab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Durvalumab. 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 101-123 of 123

  • Durvalumab before Surgery in Treating Patients with Oral Cavity or Oropharynx Cancer

    This pilot early phase I clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Immunotherapy with durvalumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread.
    Location: Wake Forest University Health Sciences, Winston-Salem, North Carolina

  • 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 for the Treatment of Relapsed or Refractory Solid Tumors, Lymphoma, or Central Nervous System Tumors

    This phase I trial studies the side effects and best dose of durvalumab in treating patients with solid tumors, lymphoma, or central nervous system tumors that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: Children's Hospital Los Angeles, Los Angeles, California

  • 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

  • JCAR014 and Durvalumab in Treating Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

    This phase Ib trial studies whether anti-CD19-chimeric antigen receptor (CAR) lentiviral vector-transduced autologous T cells (JCAR014) and durvalumab are safe in combination and can work together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). JCAR014 is made of each patient's immune cells (T cells) that have a new gene added to them in a laboratory, which programs them to kill lymphoma cells. Durvalumab is a type of drug called a monoclonal antibody, targeted to PD-L1 that may help immune cells attack cancer cells more effectively and thus help JCAR014 work better.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • 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

  • Durvalumab and Combination Chemotherapy in Treating Patients with Stage I-III Triple Negative Breast Cancer

    This phase I / II trial studies the side effects and best dose of durvalumab when given together with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients with stage I-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor (HER)2 / neu protein. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide, 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. Giving durvalumab together with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide may kill more tumor cells.
    Location: Yale University, New Haven, Connecticut

  • Phase I / II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib and / or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancers

    Background: - MEDI4736 is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer. Objectives: - Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer. Eligibility: - Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment. Design: - Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies. - Phase 2 part of the study requests the participants to have tumor samples removed. - Participants will get MEDI4636 through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression. - Participants will take olaparib or cediranib by mouth every day. - Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures. - Patients will keep a drug and diarrhea diary. - Patients on cediranib will monitor their blood pressure and keep a blood pressure diary. - Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control. - After 12 cycles, participants will have 1-3 months of follow-up.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

    This study is designed to determine the efficacy and safety of durvalumab and / or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)
    Location: University of Iowa / Holden Comprehensive Cancer Center, Iowa City, Iowa

  • Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC

    This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in subjects with locally-advanced NSCLC (stage II / III) and treated with Stereotactic Body Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without consolidation chemotherapy. A total of 60 subjects will be enrolled to this study over a 4 year accrual period.
    Location: See Clinical Trials.gov

  • Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors

    Background: Lung cancers with EGFR mutations may develop resistance to therapies targeting this protein by evolving / being transformed into small cell or neuroendocrine cancers. There are no standard treatments for it. Researchers want to see if a new combination of drugs can help. Objective: To see if the combination of durvalumab and olaparib will cause tumors to shrink. Eligibility: Adults age 18 and older who had EGFR-mutated non-small-cell lung carcinoma (NSCLC) that was treated and now transformed to SCLC or another neuroendocrine tumor. Design: Participants will be screened under a separate protocol. They may have a tumor biopsy. Participants will have a physical exam. They will have a review of their symptoms, their medicines, and their ability to do their normal activities. They will have blood tests. They will have an electrocardiogram to evaluate their heart. Participants will have a computed tomography (CT) scan, a series of x-rays taken of parts of the body. Participants will get durvalumab on Day 1 of each 28-day cycle. It is given through a small plastic tube that is put in an arm vein. They will take olaparib by mouth twice every day. They will keep a medicine diary. Participants will take the study drugs until their disease gets worse or they have unacceptable side effects. About 30 days after they stop taking the study drugs, participants will have a follow-up visit. Then they will be contacted every 6 months for the rest of their life....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • ADMIRAL Trial: Adaptive Mediastinal Radiation with Chemo-Immunotherapy

    This phase II trial studies two questions in patients with stage III NSCLC: 1) does it improve cancer control to add the drug Durvalumab, a type of immunotherapy, earlier in the treatment course; and 2) by intensifying treatment with durvalumab, is it possible to avoid mediastinal radiation to decrease side effects, without decreasing cancer control?
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Immunotherapy (Durvalumab) Combined with Radiation Therapy (Yttrium-90 Radioembolization) for the Treatment of Colorectal Cancer Metastatic to the Liver, iRE-C Trial

    This phase I trial studies the side effects and best dose of durvalumab when given together with yttrium-90 radioembolization in treating patients with colorectal cancer that has spread to the liver (liver metastases). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Yttrium-90 radio embolization is a therapy that injects radioactive beads directly into an artery that feeds liver tumors to cut off their blood supply. Giving durvalumab together with yttrium-90 radioembolization may work better than surgery for the treatment of metastatic colorectal cancer with liver metastases.
    Location: University of Iowa / Holden Comprehensive Cancer Center, Iowa City, Iowa

  • Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

    This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1 / PD-L1 based regimens
    Location: 3 locations

  • Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma

    Background: Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months. Researchers are evaluating a combination of treatment drugs to delay the progression of HCC; aiming to help people with HCC live longer. Objective: To study the 6-month progression-free survival in people with advanced HCC treated with bevacizumab, durvalumab, and TACE. Eligibility: Adults ages 18 and older with intermediate or advanced HCC Design: Participants will be screened with a physical exam and medical history. They will have tests to evaluate their hearts as well as blood and urine. A CT and / or MRI scans will be done during the study. If a prior tumor sample is not available; participants may undergo a biopsy. They may undergo an endoscopy of their esophagus and stomach. Participants will get the study drugs in 21-day cycles: Two treatment drugs will be injected into a vein every 3 weeks. Patients will have an interventional treatment procedure done by interventional radiology under sedation; chemotherapy beads will be infused into artery branches in the liver. Participants may have to stay in the hospital for 24 hours for observation, after this procedure. This interventional procedure may be done more than once during the study. Participants may need to repeat some of the screening tests throughout the study. Participants may have to stop taking some of their cancer treatment drugs during the study. Participants will continue on the study until their cancer progresses or until the side effects of the treatment drugs are not tolerable....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Acalabrutinib and Durvalumab for the Treatment of Primary or Secondary Central Nervous System Lymphoma

    This phase I trial evaluates the best dose and side effects of acalabrutinib when given together with durvalumab in treating patients with primary or secondary central nervous system lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and durvalumab may kill more tumor cells.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • 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

  • Sirolimus and Durvalumab for the Treatment of Stage I-IIIA Non-small Cell Lung Cancer

    This trial studies the side effects of sirolimus and durvalumab and to see how well they work in treating patients with stage I-IIIA non-small cell lung cancer. Sirolimus is an oral medication that blocks the mTOR cellular pathway which may help the immune system work better. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sirolimus before durvalumab may help the immune system get rid of cancer.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia

  • Restorative Microbiota Therapy and Durvalumab with or without Chemotherapy for the Treatment of Stage IIIB-IV Non-small Cell Lung Cancer

    This phase II trial studies the effect of restorative microbiota therapy and durvalumab with or without chemotherapy in treating patients with stage IIIB-IV non-small cell lung cancer. Restorative microbiota therapy is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth, and might make immunotherapy more effective. Durvalumab is a type of anti-cancer therapy that uses the patient’s own immune system to attack tumor cells. Chemotherapy drugs, such as cisplatin, pemetrexed, and carboplatin, 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. Giving restorative microbiota therapy, durvalumab, and chemotherapy may restore the gut microbiota to a better balance and result in better disease control in patients with non-small cell lung cancer.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Durvalumab with or without Oleclumab before Surgery in Treating Patients with Bladder Urothelial Carcinoma

    This phase I trial studies how well durvalumab with or without oleclumab works in treating patients with bladder urothelial carcinoma when given before standard of care surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and oleclumab, 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 Patients 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 patients with hepatocellular carcinoma or biliary tract cancer that cannot be removed via surgery (unresectable) or that has spread to other parts of the body (metastatic). 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 patients with hepatocellular carcinoma or biliary tract cancer.
    Location: 3 locations

  • Danvatirsen and Durvalumab in Treating Patients with Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer

    This phase II trial studies how well danvatirsen and durvalumab work in treating patients with pancreatic cancer, non-small cell lung cancer and mismatch repair deficient colorectal cancer that has spread to other places in the body (advanced) and does not respond to treatment (refractory). Danvatirsen may be used to block the production of proteins needed for tumor cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving danvatirsen and durvalumab may work better at treating pancreatic cancer, non-small cell lung cancer and mismatch repair deficient colorectal cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Short-term Fasting prior to Standard of Care PD-1 / PD-L1 Inhibitor Therapy for the Treatment of Advanced or Metastatic Skin Malignancy

    This phase I trial studies the side effects of short-term fasting in patients with skin malignancy that has spread to other places in the body (advanced or metastatic) treated with a PD-L1 or PD-1 inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab, cemiplimab, avelumab, atezolizumab, or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Undergoing short-term fasting prior to treatment with one of these PD-L1 or PD-1 inhibitors may potentially reduce the side effects of immunotherapy or even improve the effectiveness of immunotherapy in patients with skin malignancy.
    Location: 2 locations