Imlygic (talimogene laherparepvec) / Amgen  >>  Phase 2
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32 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Imlygic (talimogene laherparepvec) / Amgen
NCT00289016 / 2006-003841-17: A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma

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)

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

Completed
2
61
Canada, US
Talimogene laherparepvec, IMLYGIC®, OncoVEX^GM-CSF
Amgen
Melanoma
01/16
04/18
NCT02366195 / 2013-005552-15: Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

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

Checkmark Long-term results from P2 trial of talimogene laherparepvec as a neoadjuvant treatment in resectable melanoma at ESMO 2022
Sep 2022 - Sep 2022: Long-term results from P2 trial of talimogene laherparepvec as a neoadjuvant treatment in resectable melanoma at ESMO 2022
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
2018-002165-19: Reduction of the size of a wide spread white skin cancer with an oncolytic virus before surgery

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]
 
 
NCT03972046: Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

Withdrawn
2
0
US
Talimogene laherparepvec (T-Vec), Dabrafenib (BRAF Inhibitor), Trametinib (MEK Inhibitor)
TriHealth Inc., TriHealth Cancer Institute, TriHealth Surgical Institute, TriHealth Ultrasound Department, Bethesda North TriHealth Hospital, Good Samaritan TriHealth Hospital
Melanoma (Skin), Melanoma Stage IIIb-IVM1a, Metastasis Skin, Tumor Skin, BRAF Gene Mutation
02/20
02/20
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)

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.

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

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]
 
 
MASTERKEY-115, NCT04068181 / 2019-001906-61: Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy () (Mk-3475-A07/KEYNOTE-A07).

Completed
2
72
Europe, Canada, US, RoW
Talimogene laherparepvec, Pembrolizumab
Amgen, Merck Sharp & Dohme LLC
Melanoma
08/21
02/24
NCT03921073: Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma

Terminated
2
5
US
T-VEC
H. Lee Moffitt Cancer Center and Research Institute
Angiosarcoma of Skin
09/21
09/21
NCT02658812: Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery

Terminated
2
11
US
Laboratory Biomarker Analysis, Talimogene Laherparepvec, ICP34.5-, ICP47-deleted Herpes Simplex Virus 1 (HSV-1) Incorporating the Human GM-CSF Gene, Imlygic, JS1 34.5-hGMCSF 47- pA-, T-VEC
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Malignant Chest Wall Neoplasm, Recurrent Breast Carcinoma, Recurrent Inflammatory Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Inflammatory Breast Carcinoma
12/21
12/21
NCT04427306: Neoadjuvant T-VEC in High Risk Early Melanoma

Suspended
2
6
US
T-Vec, talimogene laherparepvec, Amgen
University of California, Davis, Amgen
Melanoma
06/22
05/24
KAPVEC, NCT04065152: Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma

Recruiting
2
20
Europe
Talimogene laherparepvec
Assistance Publique - Hôpitaux de Paris
Kaposi Sarcoma
02/23
02/24
NIVEC, NCT04330430: Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease

Active, not recruiting
2
24
Europe
T-VEC, Nivolumab
The Netherlands Cancer Institute, Amgen
Melanoma Stage III, Melanoma Stage IV
04/23
01/25
S1607, NCT02965716: Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

Active, not recruiting
2
42
US
Pembrolizumab, BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, SCH 900475, Talimogene Laherparepvec, ICP34.5-, ICP47-deleted Herpes Simplex Virus 1 (HSV-1) Incorporating the Human GM-CSF Gene, Imlygic, JS1 34.5-hGMCSF 47- pA-, T-VEC
National Cancer Institute (NCI)
Advanced Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Unresectable Melanoma
06/23
11/24
NCT03714828: Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

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
NCT02923778: Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery

Active, not recruiting
2
40
Canada, US
Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Talimogene Laherparepvec, ICP34.5-, ICP47-deleted Herpes Simplex Virus 1 (HSV-1) Incorporating the Human GM-CSF Gene, Imlygic, JS1 34.5-hGMCSF 47- pA-, T-VEC
National Cancer Institute (NCI)
Leiomyosarcoma, Liposarcoma, Sarcoma G2, Sarcoma G3, Soft Tissue Sarcoma, Soft Tissue Sarcoma of the Trunk and Extremities, Stage I Soft Tissue Sarcoma AJCC v7, Stage II Soft Tissue Sarcoma AJCC v7, Undifferentiated Pleomorphic Sarcoma
12/24
12/24
SOC-1882, NCT03886311: Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma

Recruiting
2
40
US
Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC], TVEC, Imlygic, Nivolumab IV Soln 100 MG/10ML, Opdivo, Trabectedin 0.25 MG/1 VIAL Intravenous Powder for Solution, Yondelis
Sarcoma Oncology Research Center, LLC
Sarcoma
12/24
03/25
NCT03069378: A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

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

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
NCT02978625: Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

Active, not recruiting
2
68
US
Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Laboratory Biomarker Analysis, Nivolumab, ABP 206, BCD-263, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Positron Emission Mammography, Talimogene Laherparepvec, ICP34.5-, ICP47-deleted Herpes Simplex Virus 1 (HSV-1) Incorporating the Human GM-CSF Gene, Imlygic, JS1 34.5-hGMCSF 47- pA-, T-VEC
National Cancer Institute (NCI)
Adnexal Carcinoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Apocrine Carcinoma, Carcinoma Arising From Cylindroma, Carcinoma Arising From Spiradenoma, Digital Papillary Adenocarcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, Extramammary Paget Disease, Extraocular Sebaceous Carcinoma, Hidradenocarcinoma, Keratoacanthoma, Malignant Sweat Gland Neoplasm, Merkel Cell Carcinoma, Microcystic Adnexal Carcinoma, NK-Cell Lymphoma, Unclassifiable, Papillary Adenocarcinoma, Porocarcinoma, Primary Cutaneous Mucinous Carcinoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Anaplastic Large Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Merkel Cell Carcinoma, Refractory Mycosis Fungoides, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Skin Squamous Cell Carcinoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sezary Syndrome, Signet Ring Cell Adenocarcinoma, Skin Adenoid Cystic Carcinoma, Skin Basal Cell Carcinoma, Skin Basosquamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Squamoid Eccrine Ductal Carcinoma, Squamous Cell Carcinoma of Unknown Primary, Sweat Gland Carcinoma, Trichilemmal Carcinoma, Vulvar Squamous Cell Carcinoma
09/25
09/25
NCT03842943: Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Recruiting
2
28
US
Pembrolizumab, Keytruda, Talimogene Laherparepvec, T-VEC, Imlygic
University of Louisville
Cutaneous Melanoma
06/26
06/28
MASTERKEY318, NCT02509507 / 2014-005386-67: Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611

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
2005-000777-21: AN EXPLORATORY STUDY OF THE SAFETY AND BIOLOGICAL ACTIVITY OF ONCOVEXGM-CSF IN COMBINATION WITH RADIOTHERAPY AND CISPLATIN IN THE TREATMENT OF LOCALLY ADVANCED EPITHELIAL CANCER OF THE HEAD AND NECK

Ongoing
1/2
20
Europe
ONCOVEXGM-CSF,
BioVex Ltd
Locally advanced epithelial cancer of the head and neck.
 
 
NCT01740297 / 2012-000307-32: Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma

Checkmark From ipilimumab combo study for unresected melanoma
Nov 2018 - Nov 2018: From ipilimumab combo study for unresected melanoma
Hourglass Jan 2017 - Dec 2017 : Presentation of data at a medical meeting from P1b/2 trial in combination with talimogene laherparepvec in stage IIIB/IV melanoma
Checkmark P1b data at ASH 2017 [screen shot]
Dec 2017 - Dec 2017: P1b data at ASH 2017 [screen shot]
More
Completed
1/2
217
Europe, US
Talimogene laherparepvec, IMLYGIC®, OncoVEX^GM-CSF, T-VEC, Ipilimumab, Yervoy®
Amgen
Melanoma
08/16
03/21
NCT02453191: TVEC and Preop Radiation for Sarcoma (4 ml Dose)

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

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

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
TITAN, NCT03555032: (Tumoural Injection of T-VEC and Isolated Limb Perfusion)

Completed
1/2
15
Europe
Talimogene laherparepvec (T-VEC)
Royal Marsden NHS Foundation Trust
Melanoma and Sarcoma
08/21
08/21
NCT04599062: TVEC and Preop Radiation for Sarcoma (8 ml Dose)

Active, not recruiting
1/2
8
US
Talimogene Laherparepvec, Radiotherapy
Mohammed Milhem, Amgen
Soft Tissue Sarcoma
02/23
11/24

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