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 53
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  • Combination Treatment (Talazoparib plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer with STK11 Gene Mutation (A LUNG-MAP Treatment Trial)

    This phase II LUNG-MAP treatment trial studies how well combination treatment (talazoparib plus avelumab) works in treating patients with non-squamous non-small cell lung cancer that has an STK11 gene mutation and has come back (recurrent) or is stage IV. Talazoparib 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. Immunotherapy drugs given as single therapies or in combination with chemotherapy do not appear to work as well in lung cancer cells with mutations in the STK11 gene versus those that do not have the mutation. Adding the medicine talazoparib to the immunotherapy drug avelumab may work better in treating lung cancers that have an STK11 gene mutation.
    Location: 351 locations

  • 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: 312 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: 29 locations

  • Trastuzumab, Vinorelbine Tartrate, and Avelumab with or without Utomilumab in Treating Patients with HER2-Positive Metastatic Breast Cancer

    This phase II trial studies the how well trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab work in treating patients with HER2-positive breast cancer that has spread to other parts of the body (metastatic). Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Immunotherapy with monoclonal antibodies, such as avelumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vinorelbine tartrate, 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. Utolimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab may work better in treating patients with breast cancer.
    Location: 26 locations

  • QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

    This is a Phase IIb, multicohort, open-label multicenter study of combination immunotherapies in patients who have previously received treatment with PD-1 / PD-L1 immune checkpoint inhibitors. All patients in Cohorts 1-4 will receive the combination treatment of PD-1 / PD-L1 checkpoint inhibitor plus N-803 for up to 17 cycles. Each cycle is six weeks in duration. Some patients who experience disease progression while on study in Cohorts 1-4 may roll over into Cohort 5 and receive combination therapy with a PD-1 / PD-L1 checkpoint inhibitor, N-803, and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles. Each cycle is six weeks in duration. All patients will receive N-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug.
    Location: 11 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

  • Testing the Addition of an Anti-cancer Drug, M6620, to the Usual Treatments (Carboplatin and Gemcitabine) and to Avelumab for Non-small Cell Lung Cancer

    This phase Ib / II trial studies the best dose of carboplatin when given together with M6620, gemcitabine and avelumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and gemcitabine, 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. 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. Giving M6620 together with carboplatin, gemcitabine, and avelumab may work better in treating patients with squamous cell non-small cell lung cancer compared to carboplatin, gemcitabine, and avelumab alone.
    Location: 9 locations

  • Rituximab in Combination with Immunotherapy in Treating Patients with Grade 1-3A Recurrent and Refractory Follicular Lymphoma

    This phase Ib trial studies the best dose of immunotherapy combinations with rituximab in treating patients with grade 1-3A follicular lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as utomilumab, PF-04518600, 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. Giving rituximab in combination with immunotherapy may work better in treating patients with follicular lymphoma.
    Location: 9 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

  • A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

    This is a Phase 1b / 2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.
    Location: 8 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

  • 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. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as well as preliminary clinical effects. The Dose Confirmation Phase will consist of two additional cohorts in patients with non-small cell lung cancer or urothelial carcinoma who will be treated at or below the MTD of PT-112 in the combination.
    Location: 5 locations

  • Avelumab with Binimetinib, Utomilumab, or anti-OX40 Antibody PF-04518600 in Treating Patients with Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

    This phase II trial studies how well avelumab in combination with binimetinib, utomilumab, or anti-OX40 antibody PF-04518600 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 patients 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. Patients on this trial will receive two weeks of treatment with one of three treatments to stimulate the bodies immune system, including the monoclonal antibodies utomilumab and the anti-OX40 antibody PF-04518600 which may help the body's immune system attack the cancer, and could interfere with the ability of tumor cells to grow and spread. 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 binimetinib, utomilumab, or anti-OX40 antibody PF-04518600 will work better in treating patients with triple negative breast cancer.
    Location: 8 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

  • Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

    This study will be a prospective, open-label, single arm, multi-center phase 2 clinical trial of mFOLFOX6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary objective of this study is to estimate the best objective response rate (CR or PR, ORR) in these patients within 24 weeks by RECIST 1.1 criteria. Secondary objectives include; estimating PFS by both RECIST 1.1 and iRECIST criteria, estimating OS, estimating the disease control rate (DCR) at 24 weeks by RECIST 1.1 and iRECIST, and characterizing the safety issues associated with this regimen.
    Location: 3 locations

  • A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

    This Phase 1b / 2 study will examine the effects of the study drugs, avelumab, binimetinib and talazoparib when given in a 2 (doublet) or 3 (triplet) drug combination, in patients with locally advanced or metastatic RAS-mutant solid tumors. The Phase 1b part of the study will assess if the different study drugs can be given together safely and which doses to use for further research. Phase 2 will test if the study treatments have an effect on tumor size and growth, and gather more information about potential side effects.
    Location: 4 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

  • 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: 4 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: 2 locations

  • Testing the Combination of New Anti-cancer Drug Nedisertib 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 nedisertib 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). Nedisertib 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 nedisertib 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: 2 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: 2 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: 5 locations

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

    This phase II trial studies the site 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: 2 locations

  • Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

    This is a Phase 1b / 2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.
    Location: 2 locations

  • 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


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