Treatment Clinical Trials for Merkel Cell Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for Merkel cell cancer treatment. 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 32
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  • Pembrolizumab Compared to Standard of Care Observation in Treating Patients with Completely Resected Stage I-III Merkel Cell Cancer, STAMP Study

    This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 421 locations

  • A Study of NKTR-262 in Combination With Bempegaldesleukin (NKTR-214) and With Bempegaldesleukin Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies

    Patients will receive intra-tumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic administration of bempegaldesleukin. After determination of the recommended Phase 2 dose (RP2D) of NKTR-262, between 6 and 18 patients may be enrolled at the RP2D to further characterize the safety and tolerability profile of the combination of NKTR 262 plus bempegaldesleukin (doublet) or NKTR 262 plus bempegaldesleukin in combination with nivolumab (triplet) in Cohorts A and B, respectively. In the Phase 2 dose expansion portion, patients will be treated with doublet or triplet in the relapsed / refractory setting and earlier lines of therapy.
    Location: 17 locations

  • Talimogene Laherparepvec and Nivolumab in Treating Patients with Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

    This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in the body (advanced) or do not responded to treatment. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and nivolumab may work better compared to usual treatments in treating patients with lymphomas or non-melanoma skin cancers.
    Location: 17 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

  • Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Advanced Solid Tumors

    This is a phase 1b / 2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two cohorts of patients: Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (CSCC). Patients in the MCC cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the CSCC cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.
    Location: 10 locations

  • This Study Evaluates KRT-232, a Novel Oral Small Molecule Inhibitor of MDM2, for the Treatment of Patients With (p53WT) Merkel Cell Carcinoma Who Have Failed Anti-PD-1 / PD-L1 Immunotherapy

    This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy. Inhibition of MDM2 is a novel mechanism of action in MCC. This study is Phase 2, Open-Label, Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma
    Location: 10 locations

  • Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

    RPL-001-16 is a Phase 1 / 2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and / or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
    Location: 8 locations

  • A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

    The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced / metastatic Merkel cell carcinoma (MCC).
    Location: 6 locations

  • Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients with Selected Unresectable or Metastatic Cancers

    This phase I trial studies how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Tacrolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tacrolimus, nivolumab, and ipilimumab may work better in treating kidney transplant recipients with cancer compared to chemotherapy, surgery, radiation therapy, or targeted therapies.
    Location: 6 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

  • High-Risk Skin Cancers With Atezolizumab Plus NT-I7

    The purpose of this study is to test whether the addition of NT-I7 to atezolizumab provides clinically meaningful outcomes for patients with anti-PD-1 / PD-L1 naive or relapsed / refractory high-risk melanoma, Merkel Cell Carcinoma (MCC) and cutaneous Squamous Cell Carcinoma (cSCC)
    Location: 5 locations

  • Immunotherapy With IFx-Hu2.0 Vaccine for Advanced MCC or cSCC

    In this clinical phase I, non-randomized, open-label, uncontrolled, interventional, multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced Merkel cell carcinoma (MCC) or cutaneous squamous cell carcinoma (cSCC) will receive a fixed dose of 0.1 mg of IFx-Hu2.0 intralesionally as monotherapy in up to three lesions at up to three time points. Subjects will be observed for any acute adverse events (AEs) post injection and for any delayed AEs at Day 28, 35 and / or 42 ± 7 days, depending on the cohort (exposure escalation and expansion design).
    Location: 4 locations

  • Intravenous TAEK-VAC-HerBy Vaccine Alone and in Combination Treatment in HER2 Cancer Patients

    A Phase 1 / 2 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced HER2- expressing cancer. The study will be completed in 3 stages. In Stage 1 patients will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 4 dose levels will be explored. Stage 2 will enroll patients with HER2- positive breast and gastric cancer to administer the TAEK-VAC-HerBy vaccine in combination with HER2 antibodies. Stage 3 will enroll patients to evaluate the safety and tolerability of the TAEK-VAC-HerBy vaccine in combination with HER2 antibodies and PD-1 / PD-L1 antibody. Patients, in all three stages, will receive TAEK-VAC-HerBy every three weeks, three administrations in total.
    Location: 4 locations

  • Evaluating Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

    A Phase 1a / 1b, multicenter, open-label, non-randomized, dose-escalation, and cohort expansion study to examine the DLTs, MTD, and RP2D of SB 11285 administered as an IV infusion in patients with advanced solid tumors.
    Location: 3 locations

  • Talimogene Laherparepvec with or without Hypofractionated Radiation Therapy in Treating Patients with Metastatic Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

    This randomized phase II trial studies the side effects of talimogene laherparepvec and to see how well it works with or without hypofractionated radiation therapy in treating patients with skin melanoma, Merkel cell carcinoma, or other solid tumors that have spread to places not suitable for surgical removal. Drugs used in the immunotherapy, such as talimogene laherparepvec, may stimulate the body's immune system to fight tumor cells. 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. It is not yet known if giving talimogene laherparepvec with or without hypofractionated radiation therapy will work better in treating patients with cutaneous melanoma, Merkel cell carcinoma, or solid tumors.
    Location: 3 locations

  • Study of SO-C101 and SO-C101in Combination With Pembro in Adult Patients With Advanced / Metastatic Solid Tumors

    A multicenter open-label phase 1 / 1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced / metastatic solid tumors
    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

  • FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

    FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.
    Location: 3 locations

  • Nivolumab and Ipilimumab with or without Stereotactic Body Radiation Therapy in Treating Patients with Recurrent or Stage IV Merkel Cell Cancer

    This randomized phase II trial studies how well nivolumab and ipilimumab with or without stereotactic body radiation therapy work in treating patients with Merkel cell cancer that has come back or is stage IV. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and 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 nivolumab and ipilimumab with or without stereotactic body radiation therapy may work better in treating patients with Merkel cell cancer.
    Location: 2 locations

  • Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)

    This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.
    Location: Icahn School of Medicine at Mount Sinai, New York, New York

  • A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

    The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
    Location: Hackensack University Medical Center, Hackensack, New Jersey

  • Focused Ultrasound Ablation and PD-1 Antibody Blockade for the Treatment of Advanced Solid Tumors

    This phase I trial studies the side effects of focused ultrasound ablation and how well it works with or without PD-1 antibody blockade (a type of immune infused therapy drug) in treating patients with solid tumors that has spread to other places in the body (advanced). PD-1 antibody blockade is a type of treatment that uses an antibody that has been created to bind to immune cells to enable them to fight off cancer more effectively. The Echopulse device is a computer driven system which guides a high intensity focused ultrasound beam (focused sound waves) to a targeted area of a tumor. Focused ultrasound ablation (FUSA) heats the targeted site which causes the cells to die. In addition to the focused ultrasound beam that can kill cells at its target, the Echopulse device also uses low energy ultrasound for imaging the tumor tissue and the tissue around the tumor to make sure that the focused ultrasound beam hit its target. Imiquimod is an immunomodulator, a drug that interacts with the immune system. Through boosting the immune system, imiquimod may help the body fight off cancer cells. The purpose of this trial is to figure out the safety and effectiveness of FUSA administration alone or with a PD-1 antibody and / or imiquimod.
    Location: University of Virginia Cancer Center, Charlottesville, Virginia

  • Cell Therapy for the Treatment of Locally Advanced, Metastatic, or Recurrent Solid Cancers

    This phase II trial studies how well cell therapy (with tumor infiltrating lymphocytes) works for the treatment of solid cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other parts of the body (metastatic), or has come back (recurrent). This trial involves taking cells called lymphocytes (a type of white blood cell) from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called tumor infiltrating lymphocytes and the therapy is called cell therapy. Giving chemotherapy drugs, such as cyclophosphamide and fludarabine, before treating with these cells may temporarily suppress the immune system to improve the chances that the tumor fighting cells will be able to survive in the body. Giving aldesleukin after the cell administration may help the tumor fighting cells stay alive longer. Giving tumor fighting cells (tumor infiltrating lymphocytes) followed by aldesleukin may cause the cancer to shrink.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients with Metastatic or Unresectable Merkel Cell Cancer

    This phase I / II trial studies the side effects of gene-modified immune cells (FH-MCVA2TCR) and to see how well they work in treating patients with Merkel cell cancer that has spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable). Placing a gene that has been created in the laboratory into immune cells may improve the body's ability to fight Merkel cell cancer.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington


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