Clinical Trials Using Avelumab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Avelumab. 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 51
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  • Testing what Happens when an Immunotherapy Drug (Avelumab) Is Added to a Usual Drug Treatment (Cetuximab) Compared to Avelumab by Itself in the Treatment of Advanced Squamous Cell Carcinoma of the Skin (cSCC)

    This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 385 locations

  • Trying to Find the Correct Length of Treatment with Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma

    This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping the treatment with immune checkpoint inhibitors early in patients who have been responding to such therapy for approximately 1 year, may not change the benefit of treatment. This is because their immune system may continue to attack the tumor cells even if the treatment has stopped. A possible reason may be that the immune system has memory and remembers what it sees, including the cancer cells that it attacks. Stopping treatment with checkpoint inhibitors early may result in similar survival rate as if the treatment had not stopped and may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.
    Location: 283 locations

  • Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy with or without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial

    This phase III trial compares standard systemic treatment alone versus standard systemic treatment plus surgery to remove all or part of the affected kidney (cytoreductive nephrectomy) in treating patients with kidney cancer that has spread to other places in the body (metastatic). Standard systemic therapy for this type of cancer is immunotherapy-based combination therapy which may shrink the tumor and stimulate the immune system to attack the cancer. Systemic therapy is a type of treatment when drugs travel through the blood to cells all over the body. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cytoreductive nephrectomy is a surgical procedure to remove as many cancer cells from the kidney as possible. This study will help determine whether addition of surgery to standard of care systemic therapy is better than systemic therapy alone for the treatment of metastatic kidney cancer.
    Location: 199 locations

  • Fulvestrant with or without Palbociclib and Avelumab in Treating Patients with Hormone Receptor Positive, HER2 Negative Metastatic or Recurrent Breast Cancer That Cannot Be Removed by Surgery Previously Treated with CDK and Endocrine Therapy

    This randomized pilot phase II trial studies how well fulvestrant with or without palbociclib and avelumab works in treating patients with hormone receptor positive, HER2 negative breast cancer that has spread to other parts of the body or that has come back after a period of improvement and cannot be removed by surgery, and have been previously treated with CDK and endocrine therapy. Endocrine therapy with fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of tumor cells by estrogen. Palbociclib is a drug that may stop tumor cells from growing by blocking activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called cyclin dependent kinases 4 and 6 (CDK 4 / 6) which are known to promote tumor cell growth. Monoclonal antibodies, such as avelumab, may help the immune system in detecting and fighting tumor cells. Giving fulvestrant with or without palbociclib and avelumab may work better in treating patients with breast cancer.
    Location: 30 locations

  • Radiation Medication (Radium-223 dichloride) versus Radium-223 dichloride plus Radiation Enhancing Medication (M3814) versus Radium-223 dichloride plus M3814 plus Avelumab (a type of immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy

    This phase I / II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.
    Location: 15 locations

  • A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study

    The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy [paclitaxel] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+) / Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.
    Location: 13 locations

  • Adjuvant Avelumab in Merkel Cell Cancer

    This randomized phase III trial studies how well avelumab works in treating patients with Merkel cell cancer that has spread to the lymph nodes and have undergone surgery and / or radiation therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 10 locations

  • Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer

    This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 / PD-L1 based immunotherapy. At least 321 patients are anticipated to be enrolled across approximately 40 sites from North America and Europe.
    Location: 11 locations

  • Study of Avelumab and / or Radiation Therapy for Treatment of Stage III-IV Merkel Cell Carcinoma

    This phase II trial studies the effects of comprehensive ablative radiation therapy (CART) with or without avelumab in treating patients with stage III-IV Merkel cell carcinoma. CART is a type of radiation therapy that has been shown to shrink tumors and prevent cancer from coming back. Avelumab is a type of drug called a PD-L1 inhibitor; it blocks a protein found on tumor cells and some immune cells, where the protein acts as a shield that prevents the cancer cells from being attacked by the immune system. When avelumab attaches to PD-L1, it can break up the protective shield and help the immune system recognize and kill cancer cells. Giving avelumab with radiation therapy may work better in treating patients with Merkel cell carcinoma compared to radiation therapy alone.
    Location: 7 locations

  • Talazoparib and Avelumab for the Treatment of Metastatic Renal Cell Carcinoma

    This phase II trial studies how well talazoparib and avelumab work in treating patients with renal cell carcinoma (the most common kidney cancer) that has spread to other places in the body (metastatic). Avelumab is an antibody that recognizes and attaches to a molecule called PD-L1. PD-L1 is found on the surface of some tumor cells, where it functions like a shield to prevent the tumor cells from being attacked by the immune system. When avelumab attaches to PD-L1, it may break up the protective shield and may help the immune system recognize and kill tumor cells. Talazoparib inhibits (stops) the normal activity of certain molecules called PARPs. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body’s instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control. But PARP inhibitors like talazoparib have been shown to keep PARP from working, so tumor cells can’t repair themselves, and they stop growing. Giving avelumab and talazoparib together may be more effective than giving either drug alone in treating patients with renal cell cancer.
    Location: 7 locations

  • Study of Avelumab-M3814 Combinations

    The main purpose of the study is to evaluate a safe, tolerable recommended Phase II dose (RP2D) and / or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.
    Location: 6 locations

  • Testing the Combination of New Anti-cancer Drug Peposertib with Avelumab and Radiation Therapy for Advanced / Metastatic Solid Tumors and Hepatobiliary Malignancies

    This phase I / II trial studies the best dose and side effects of peposertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced / metastatic). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, 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 peposertib in combination with avelumab and hypofractionated radiation therapy may work better than other standard chemotherapy, hormonal, targeted, or immunotherapy medicines available in treating patients with solid tumors and hepatobiliary malignancies.
    Location: 7 locations

  • Avelumab with Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients with Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

    This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
    Location: 10 locations

  • A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

    This is a Phase 1b / 2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.
    Location: 5 locations

  • Avelumab, Talazoparib, and Axitinib in Treating Patients with MSS, MSI-H, and POLE-Mutated Recurrent or Persistent Endometrial Cancer

    This phase II trial studies how well avelumab together with talazoparib or axitinib work in treating patients with microsatellite stable (MSS), high frequency microsatellite instability (MSI-H), and polymerase e (POLE)-mutated endometrial cancer that has come back (recurrent) or does not go to remission despite treatment (persistent). Immunotherapy with monoclonal antibodies, such as avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Talazoparib and axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab together with talazoparib or axitinib may work better in treating MSS endometrial cancer compared to avelumab alone.
    Location: 5 locations

  • GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

    This is a phase I / Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.
    Location: 4 locations

  • FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

    This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in subjects with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
    Location: 3 locations

  • Talazoparib and Avelumab for the Treatment of Advanced Breast Cancer, the TALAVE study

    This phase I / II trial studies the side effects of talazoparib and avelumab for the treatment of breast cancer that has spread to other places in the body (advanced). Avelumab is a type of protein that recognizes and attaches to other proteins in the body. It specifically recognizes and attaches to a protein called PD-L1 which is found on the surface of some cancer cells, where it acts to protect those cells from being attacked by the immune system (the part of the body that fights infection but which is also involved in fighting cancer). When avelumab attaches to PD-L1, it stops PD-L1 from working and so allows the immune system to recognize and kill the cancer cells. Talazoparib is a drug that stops the activity of a protein called PARP. PARP is involved in repairing damage to the deoxyribonucleic acid (DNA) within cells. When PARP is turned off by talazoparib in cancer cells, DNA damage cannot be repaired and leads to the death of the cancer cells. Giving talazoparib and avelumab may have the capacity to increase the response to immunotherapy.
    Location: 3 locations

  • QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy

    Phase 2, single-arm study to evaluate combination therapy of avelumab, haNK and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR. Patients will receive treatment for a maximum of two years.
    Location: 4 locations

  • Avelumab Program Rollover Study

    The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
    Location: 3 locations

  • Avelumab and Bladder-Directed Radiation in Treating Cisplatin-Ineligible Patients with Muscle-Invasive Bladder Urothelial Cancer

    This phase II trial studies the side effects and how well avelumab works when given together with bladder-targeted radiation in treating cisplatin-ineligible patients with muscle-invasive bladder urothelial cancer. Immunotherapy with monoclonal antibodies, such as avelumab, 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, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. Giving avelumab and bladder-directed radiation may work better in treating patients with muscle-invasive bladder urothelial cancer.
    Location: 3 locations

  • Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Patients With Refractory Solid Tumors

    This is a three-part open label phase 1 study designed to determine the safety profile, MTD, PK and tumor and biomarker response after IT or IV administration of a single dose of VSV-IFNβ-NIS, or combined IT followed by IV VSV-IFNβ-NIS, with or without IV avelumab every two weeks, in patients with refractory advanced / metastatic solid tumors. The study consists of three parts: a single ascending dose escalation of IT VSV-IFNβ-NIS monotherapy, a monotherapy regimen selection phase (IT alone, IT then IV, or IV alone) and an expansion phase, designed to explore the safety and efficacy of the chosen monotherapy regimen alone or in combination with avelumab in patients with metastatic colorectal cancer, pheochromocytoma and neuroendocrine tumor (NET) patients . This phase contains a small dose de-escalation-re-escalation period to ensure the safety of the combination prior to opening the corresponding expansion cohort.
    Location: 3 locations

  • Avelumab or Hydroxychloroquine with or without Palbociclib for the Treatment of Stage II-III Breast Cancer, PALAVY Study

    This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4 / 6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4 / 6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called “autophagy” to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the body’s immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseases—including cancers. One way the immune system controls the activity of T cells is through the PD-1 / PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1 / PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1 / PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • Intermittent Checkpoint Inhibitor Therapy for the Treatment of Advanced or Metastatic Urothelial Cancer

    This phase II trial studies how well intermittent checkpoint inhibitor therapy works in treating patients with urothelial cancer that has spread to other places in the body (advanced or metastatic). Checkpoint inhibitors, such as pembrolizumab, atezolizumab, durvalumab, nivolumab, and avelumab, are drugs that work by helping the immune system recognize and kill cancer cells. This study is being done to find out whether intermittent checkpoint inhibitor therapy works the same, better, or worse than continued checkpoint inhibitor therapy in treating patients with urothelial cancer.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors

    This phase I / II trial studies the side effects and best dose of avelumab with M6620 in treating patients with deoxyribonucleic acid (DNA) damage repair (DDR) deficient solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). DDR deficiency refers to a decrease in the ability of cells to respond to damaged DNA and to repair the damage, which can be caused by genetic mutations. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab together with M6620 may help to control DDR deficient metastatic or unresectable solid tumors.
    Location: M D Anderson Cancer Center, Houston, Texas


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