Imlygic (talimogene laherparepvec) / Amgen |
| Completed | 2 | 50 | US, Europe | Talimogene Laherparepvec, OncoVEX^GM-CSF, T-VEC, IMLYGIC | BioVex Limited, Symbion Research International | Melanoma | 12/08 | 05/09 | | |
NCT02574260: An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016) |
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| Completed | 2 | 3 | NA | Talimogene Laherparepvec, OncoVEX^GM-CSF, T-VEC, IMLYGIC | BioVex Limited, Covance | Melanoma | 01/10 | 01/10 | | |
NCT02014441: Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec |
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| Completed | 2 | 61 | Canada, US | Talimogene laherparepvec, IMLYGIC®, OncoVEX^GM-CSF | Amgen | Melanoma | 01/16 | 04/18 | | |
| Completed | 2 | 112 | Europe, US, RoW | Talimogene Laherparepvec, IMLYGIC® | Amgen | Unresected Stage IIIb to IVM1c Melanoma | 06/17 | 12/20 | | |
NCT02211131 / 2014-001146-13: Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma |
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| Completed | 2 | 150 | Europe, US, RoW | Talimogene Laherparepvec, Immediate surgical resection of melanoma lesion(s) | Amgen | Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma | 04/19 | 04/22 | | |
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2018-002165-19: Reduction of the size of a wide spread white skin cancer with an oncolytic virus before surgery |
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| Ongoing | 2 | 40 | Europe | Talimogene laherparepvec (Imlygic), Solution for injection, Imlygic Talimogene Laherparepvec | Medical University Vienna, Amgen | Basal cell carcinoma (BCC) is the most common malignant neoplasm in fair skinned humans (Rubin et al., 2005). Over the last decades its incidence has increased (Chinem and Miot, 2011). Especially when it comes to BCCs of intermediate size, a surgical approach, while still feasible is often associated with complications and often requires major reconstructive surgery with a suboptimal cosmetic outcome. We hypothesize that neoadjuvant Talimogene laherparepvec minimizes the size of the BCC., White skin cancer is a very common disease. Wide spread white skin cancer is difficult to treat. We hypothesize that the size of the tumor reduces through oncolytic virotherapy before surgery., Diseases [C] - Cancer [C04] | | | | |
2018-002677-22: Doppler sonography (non-invasive test that calculates blood flow in blood vessels) of skin and nodal metastases (cancer spread from the skin, where it was originally formed, to the nodal tissue) as a predictor of clinical response to Talimogene Laherparepvec (T-VEC), biopharmaceutical drug to treat melanoma lesions that can not be operated, in melanoma patients (T-VEC – US Doppler) Ecografía Doppler (prueba no invasiva que calcula el flujo de la sangre en los vasos sanguíneos) de piel y metástasis ganglionares (diseminación del cáncer desde la piel, donde se formó originalmente, al tejido ganglionar) como predictor de la respuesta clínica a Talimogene Laherparepvec (T-VEC), medicamento biofarmacéutico para tratar lesiones de melanoma que no pueden operarse, en pacientes con melanoma (T-VEC - US Doppler) |
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| Not yet recruiting | 2 | 25 | Europe | Talimogene Laherparepvec, AMG 678, Solution for solution for injection, IMLYGIC | Fundació Clínic per a la Recerca Biomèdica, AMGEN S.A. | Melanoma stage IIIB-IVM1a Melanoma estadío IIIB-IVM1a, Melanoma (most serious type of skin cancer) in stage IIIB (cancer present in skin cells and in lymphatic ganglia) to IVM1a (cutaneous metastases, subcutaneous and ganglionic at distance) Melanoma (cáncer de piel más grave) estadio IIIB (cáncer presente en células de la piel y en ganglios linfáticos) a IVM1a (metástasis cutáneas, subcutáneas y ganglionares a distancia, Diseases [C] - Cancer [C04] | | | | |
2019-001911-22: A study in melanoma patients with metastases in the lymph nodes and/or on/under the skin who will be treated with T-VEC and nivolumab before surgery. |
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| Not yet recruiting | 2 | 24 | Europe | Nivolumab, Talimogene Laherparepvec, AMG 678, Solution for injection/infusion, Solution for infusion, Opdivo, Imlygic | Antoni van Leeuwenhoek Ziekenhuis, Bristol Myers Squibb (BMS), Amgen | Patients with early metastatic (stage IIIB/C/D/IV M1a (AJCC 8)) melanoma Patienten met vroeg gemetastaseerd (stadium IIIB/IIIC of IVM1a) melanoom, Patients with skin cancer with metastases to the lymph nodes and/or on/under the skin Patienten met huidkanker met uitzaaiingen in de lymfeklieren en/of op/onder de huid, Diseases [C] - Cancer [C04] | | | | |
2019-004403-12: Phase II multicenter study of talimogene laherparepvec in classic or endemic Kaposi sarcoma Kapvec Study Essai clinique de phase II multicentrique évaluant le talimogene laherparepvec dans la maladie de Kaposi classique ou endémique |
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| Not yet recruiting | 2 | 20 | Europe | talimogene laherparepvec, Solution for injection, Imlygic | ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS, Amgen | The study will provide an overview of efficacy and safety of talimogene laherparepvec in classic and endemic KS traitement par T-Vec de patients atteints du Sarcome de Kaposi., Diseases [C] - Cancer [C04] | | | | |
| Completed | 2 | 72 | Europe, Canada, US, RoW | Talimogene laherparepvec, Pembrolizumab | Amgen, Merck Sharp & Dohme LLC | Melanoma | 08/21 | 02/24 | | |
| Suspended | 2 | 6 | US | T-Vec, talimogene laherparepvec, Amgen | University of California, Davis, Amgen | Melanoma | 06/22 | 05/24 | | |
NIVEC, NCT04330430: Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease |
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| Active, not recruiting | 2 | 24 | Europe | T-VEC, Nivolumab | The Netherlands Cancer Institute, Amgen | Melanoma Stage III, Melanoma Stage IV | 04/23 | 01/25 | | |
NCT03714828: Study of TVEC in Patients With Cutaneous Squamous Cell Cancer |
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| Completed | 2 | 11 | US | Injection of TVEC into target lesions - week 1-2, Injection of TVEC into target lesions 3wks after 1st injection, Injection of TVEC into target lesions 2wks after 2nd injection, Injection of TVEC into target lesions 2wks after 3rd injection | University of Arizona, Amgen | Squamous Cell Carcinoma, Skin Cancer, Keratoacanthoma, Cutaneous Tumor, Skin Cancer, Squamous Cell, Lesion Skin | 07/23 | 07/23 | | |
NCT03069378: A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma |
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| Active, not recruiting | 2 | 41 | US | Talimogene Laherparepvec (T-VEC), Pembrolizumab | Memorial Sloan Kettering Cancer Center, Amgen, Merck Sharp & Dohme LLC | Sarcoma, Epithelioid Sarcoma, Cutaneous Angiosarcoma | 03/25 | 03/25 | | |
NCT02819843: A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors |
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| Completed | 2 | 19 | US | TALIMOGENE LAHERPAREPVEC (TVEC), Hypofractionated Radiotherapy | Memorial Sloan Kettering Cancer Center, Amgen | Melanoma, Merkel Cell Carcinoma, Other Solid Tumors | 02/24 | 02/24 | | |
| Completed | 1b/2 | 127 | Europe, US, RoW | Talimogene Laherparepvec, Pembrolizumab | Amgen, Merck Sharp & Dohme LLC | Hepatocellular Carcinoma, Liver Metastases, Cutaneous or Subcutaneous Lymph Node, Liver Tumors | 02/22 | 07/23 | | |
| Completed | 1/2 | 217 | Europe, US | Talimogene laherparepvec, IMLYGIC®, OncoVEX^GM-CSF, T-VEC, Ipilimumab, Yervoy® | Amgen | Melanoma | 08/16 | 03/21 | | |
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NCT02453191: TVEC and Preop Radiation for Sarcoma (4 ml Dose) |
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| Completed | 1/2 | 30 | US | Talimogene Laherparepvec, Radiotherapy | University of Iowa, Amgen | Soft Tissue Sarcoma | 01/19 | 03/23 | | |
NCT03597009: A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion |
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| Terminated | 1/2 | 1 | US | Talimogene laherparepvec (TVEC), Imlygic, OncoVex, Nivolumab, Opdivo | UNC Lineberger Comprehensive Cancer Center, CareFusion, Amgen | Malignant Pleural Effusion, Stage IV Metastatic Cancer, Lung Cancer | 02/20 | 02/20 | | |
NCT02779855: Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer |
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| Active, not recruiting | 1/2 | 50 | US | Talimogene laherparepvec, IMLYGIC™, modified herpes simplex 1 virus, Paclitaxel, Taxol® | H. Lee Moffitt Cancer Center and Research Institute, Amgen | Breast Cancer, Ductal Carcinoma, Invasive Breast Carcinoma, Invasive Ductal Breast Carcinoma | 09/20 | 08/24 | | |
NCT04599062: TVEC and Preop Radiation for Sarcoma (8 ml Dose) |
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| Active, not recruiting | 1/2 | 8 | US | Talimogene Laherparepvec, Radiotherapy | Mohammed Milhem, Amgen | Soft Tissue Sarcoma | 02/23 | 11/24 | | |