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: 423 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: 18 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: 15 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: 15 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

  • 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: 11 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: 8 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: 7 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

  • 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: 7 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

  • 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

  • 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: 5 locations

  • Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors

    The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
    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

  • 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

  • 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-C101 in 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

  • 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

  • Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel

    Background: People with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see if these drugs together can make rare cancers shrink or stop growing. Objective: To learn if nilotinib and paclitaxel will benefit people with rare cancers. Eligibility: People age 18 and older who have a rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: Participants will be screened with medical history and physical exam. They will have blood and urine tests. They will have a pregnancy test if needed. They will have an electrocardiogram to check their heart. They will have imaging scans to measure their tumors. Participants will repeat the screening tests during the study. Participants will receive nilotinib and paclitaxel. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle. Participants will keep a medicine diary. They will track when they take the study drugs and any side effects they may have. Participants may have optional tumor biopsies. Participants can stay on the study until their disease gets worse or they have intolerable side effects. Participants will have a follow-up phone call about 30 days after taking the last dose of study drugs.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

    This study is a Phase 1 / 2, open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab.
    Location: 2 locations

  • Pembrolizumab and Radiation Therapy for the Treatment of Metastatic Merkel Cell Carcinoma

    This phase II trial studies the side effects and how well pembrolizumab and radiation therapy work in treating patients with Merkel cell carcinoma that has spread to other places in the body (metastatic). 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy may increase the benefit of pembrolizumab.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • 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


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