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 55
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  • Avelumab with or without Cetuximab in Treating Patients with Advanced Skin Squamous Cell Cancer

    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: 257 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: 22 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. Immunotherapy with monoclonal antibodies, such as trastuzumab, avelumab, and utomilumab, 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. Giving trastuzumab, vinorelbine tartrate, and avelumab with or without utomilumab may work better in treating patients with breast cancer.
    Location: 16 locations

  • Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

    Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).
    Location: 14 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: 12 locations

  • Javelin BRCA / ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

    Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.
    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 with or without radiation therapy. Monoclonal antibodies, such as avelumab, may stimulate the immune system and interfere with the ability of tumor cells to grow and spread.
    Location: 10 locations

  • QUILT-3.055: A Study of ALT-803 in Combination With PD-1 / PD-L1 Checkpoint Inhibitor in Patients With Advanced Cancer

    This is a Phase IIb, single-arm, multicohort, open-label multicenter study of ALT-803 in combination with an FDA-approved PD-1 / PD-L1 checkpoint inhibitor in patients with advanced cancers who have progressed following an initial response to treatment with PD-1 / PD-L1 checkpoint inhibitor therapy. All patients will receive the combination treatment of PD-1 / PD-L1 checkpoint inhibitor plus ALT-803 for up to 16 cycles. Each cycle is six weeks in duration. All patients will receive ALT-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: 9 locations

  • Avelumab and Stereotactic Body Radiation Therapy in Treating Patients with Malignant Mesothelioma

    This phase I / II trial studies how well avelumab and stereotactic body radiation therapy work in treating patients with malignant mesothelioma. Monoclonal antibodies, such as avelumab, may interfere with the ability of tumor cells to grow and spread. 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. Giving avelumab and stereotactic body radiation therapy may work better in treating patients with malignant mesothelioma.
    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: 5 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 and Talazoparib in Treating Patients with MSS, MSI-H, and POLE-Mutated Recurrent or Persistent Endometrial Cancer

    This phase II trial studies how well avelumab and talazoparib work in treating patients with microsatellite stable (MSS), high frequency microsatellite instability (MSI-H), and polymerase e (POLE)-mutated endometrial cancer that has spread to other places in the body or that does not go to remission despite treatment. 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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab and talazoparib may work better in treating MSS endometrial cancer compared to avelumab alone.
    Location: 5 locations

  • Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides

    This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. The study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase. The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.
    Location: 5 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 and binimetinib given together (doublet) and in combination with talazoparib (triplet), 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

  • 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 or does not respond to treatment. Immunotherapy with rituximab, utomilumab, and PF-04518600 may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. 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 rituximab in combination with immunotherapy may work better in treating patients with follicular lymphoma.
    Location: 4 locations

  • Avelumab in Treating Patients with Recurrent or Progressive Osteosarcoma

    This phase II trial studies how well avelumab works in treating patients with osteosarcoma that has come back or is growing, spreading, or getting worse. Monoclonal antibodies, such as avelumab, may interfere with the ability of tumor cells to grow and spread.
    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 for the Treatment of Muscle Invasive Bladder Cancer

    This early phase I trial studies how well avelumab works in treating patients with muscle invasive bladder 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. Specifically, avelumab may increase the body’s ability to fight cancer with anti-tumor white blood cells called lymphocytes. Avelumab may have an effect on the cancer, but it is not yet known if the planned treatment duration is long enough to control the cancer.
    Location: 3 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: 3 locations

  • A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)

    The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of M9241, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of M9241 with avelumab intravenous (IV).
    Location: 5 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. 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 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

  • Phase I / II Study of Avelumab in Pediatric Cancer Subjects

    This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervous system tumors) and lymphoma for which no standard therapy is available or for which the subject is not eligible for the existing therapy.
    Location: 3 locations

  • VX15 / 2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer

    The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15 / 2503 in combination with a fixed dose of avelumab in patients with advanced non-small cell lung cancer. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) of VX15 / 2503 administered in combination with avelumab.
    Location: 2 locations

  • Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in People With Previously Untreated Metastatic Colorectal Cancer QUILT-2.004

    Background: Colorectal cancer is a common cancer in the U.S. It causes the second most cancer-related deaths. The drug avelumab and vaccine Ad-CEA together help the immune system fight cancer. Objective: To test if avelumab and Ad-CEA plus standard therapy treats colorectal cancer that has spread to other sites better than standard therapy alone. Eligibility: People ages 18 and older with untreated colorectal cancer that has spread in the body Design: Participants will be screened with: Test to see if their cancer has a certain deficiency Blood, urine, and heart tests Scans Medical history Physical exam Tumor sample. This can be from a previous procedure. A small group of participants will get Ad-CEA and avelumab plus standard therapy. This is FOLFOX plus bevacizumab for up to 24 weeks then capecitabine plus bevacizumab. The others will have treatment in 2-week cycles. They will be Arm A or B: Arm A: FOLFOX and bevacizumab by IV days 1 and 2 for 12 cycles. After that, capecitabine by mouth twice a day and bevacizumab by IV on day 1. Arm B: Ad-CEA injection every 2-12 weeks. Avelumab by IV on day 1 of each cycle. FOLFOX and bevacizumab by IV days 2 and 3 for 12 cycles. Then, capecitabine by mouth twice a day and bevacizumab through IV on day 2. Participants will repeat screening tests during the study. Participants will be treated until their disease gets worse or they have bad side effects. Arm A participants can join Arm B. They will have a visit 4 5 weeks after they stop therapy.
    Location: 2 locations


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