Imlygic (talimogene laherparepvec) / Amgen 
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 23 Diseases   21 Trials   21 Trials   1283 News 


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  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal:  Construction of Oncolytic Herpes Simplex Virus with Therapeutic Genes of Interest. (Pubmed Central) -  Jul 4, 2019   
    The large genome size of HSV readily allows arming of oHSV by incorporating therapeutic transgenes within the virus, as exemplified by T-VEC carrying GM-CSF, thereby enhancing the anticancer activity of oHSV. Here we describe a bacterial artificial chromosome-based method for construction of an oHSV expressing a transgene, which we routinely use in the laboratory to create a number of different recombinant oHSV bearing either therapeutic or reporter genes.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Trial completion date, Trial primary completion date, Combination therapy:  Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases (clinicaltrials.gov) -  Jun 28, 2019   
    P1b,  N=36, Recruiting, 
    Here we describe a bacterial artificial chromosome-based method for construction of an oHSV expressing a transgene, which we routinely use in the laboratory to create a number of different recombinant oHSV bearing either therapeutic or reporter genes. Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Jun 2019 --> Jun 2020
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal:  Exanthem nach einmaliger Injektion von T-VEC. (Pubmed Central) -  Jun 27, 2019   
    Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Jun 2019 --> Jun 2020 No abstract available
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal, Oncolytic Virus, Immunogenic cell death, PD(L)-1 Biomarker, IO Biomarker:  Oncolytic virus immunotherapy induces immunogenic cell death and overcomes STING deficiency in melanoma. (Pubmed Central) -  May 31, 2019   
    In the D4M3A melanoma, which has low expression of STING and is resistant to PD-1 blockade therapy, T-VEC was able to induce therapeutic responses in both injected and non-injected tumors and demonstrated recruitment of viral- and tumor-antigen specific CD8 T cells, and induction of a pro-inflammatory gene signature at both injected and non-injected tumors. These data suggest that T-VEC induces ICD in-vitro and promotes tumor immunity and can induce therapeutic responses in anti-PD-1-refractory, low STING expressing melanoma.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / PharmaMar, J&J, Opdivo (nivolumab) / BMS
    Enrollment open:  SOC-1882: Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma (clinicaltrials.gov) -  May 19, 2019   
    P2,  N=40, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
    Review, Journal:  Malignant melanoma : Current status (Pubmed Central) -  Apr 26, 2019   
    An individual definition of the appropriate therapy for each patient is of particular importance. In the context of modern therapy regimens close patient monitoring is crucial.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal:  Regional therapies for locoregionally advanced and unresectable melanoma. (Pubmed Central) -  Apr 17, 2019   
    ...Intralesional therapies, for in transit metastatic melanoma, such as Bacille Calmette-Guerin, talimogene laherparepvec, and PV-10 (Rose Bengal) have all demonstrated efficacy in the treatment of unresectable cutaneous melanoma...Treatment options for unresectable melanoma metastases limited to the liver include isolated hepatic perfusion, which can now be performed through a minimally invasive approach known as percutaneous hepatic perfusion. These intra-arterial and intralesional regional therapies offer a variety of effective treatment modalities for unresectable disease and may potentially be combined with systemic treatments, such as immunotherapy, in the future treatment of locoregionally advanced melanoma.
  • ||||||||||  Journal, Oncolytic Virus:  Engineered oncolytic viruses to treat melanoma: where are we now and what comes next? (Pubmed Central) -  Apr 17, 2019   
    ...One such oncolytic virus is talimogene laherparepvec (T-VEC), which is the first approved therapy of its kind for use in recurrent, unresectable stage IIIB-IVM1a melanoma...Additional viral vectors show acceptable safety profiles and varying degrees of efficacy in targeting melanoma. The indications for use of oncolytic viruses will expand as their efficacy and appropriate usage is better understood in coming years.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Clinical, Review, Journal, Oncolytic Virus:  Current status of clinical trials assessing oncolytic virus therapy for urological cancers. (Pubmed Central) -  Apr 10, 2019   
    ...Notably, T-VEC (talimogene laherparepvec, formerly called OncoVEX ), an oncolytic herpes simplex virus type 1, was approved by the US Food and Drug Administration for the treatment of inoperable melanoma in October 2015, and was subsequently approved in Europe and Australia in 2016...In addition to Herpes simplex virus type 1, adenoviruses, reoviruses, vaccinia virus, Sendai virus and Newcastle disease virus have also been used as parental viruses in these trials. We believe that oncolytic virus therapy is likely to become an important and major treatment option for urological cancers in the near future.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Review, Journal, Oncolytic Virus, Checkpoint inhibition:  Combining Tumor Vaccination and Oncolytic Viral Approaches with Checkpoint Inhibitors: Rationale, Pre-Clinical Experience, and Current Clinical Trials in Malignant Melanoma. (Pubmed Central) -  Apr 7, 2019   
    The field of tumor immunology has faced many complex challenges over the last century, but the approval of immune checkpoint inhibitors (anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] and anti-programmed cell death-1 [PD-1]/PD-ligand 1 [PD-L1]) and talimogene laherparepvec (T-VEC) for the treatment of metastatic melanoma have awakened a new wave of interest in cancer immunotherapy...Here, we review key basic concepts of tumor-induced immune suppression in malignant melanoma, the historical perspective around vaccine development in melanoma, and advances in oncolytic viral therapies. We also discuss the emerging role for combination approaches with different immunomodulatory agents as well as new developments in personalized immunization approaches.
  • ||||||||||  Review, Journal:  Beyond PD-1 Immunotherapy in Malignant Melanoma. (Pubmed Central) -  Mar 31, 2019   
    A number of clinical trials are currently being conducted to confirm their effectiveness and safety. In this review of the literature, we summarize the contemporary knowledge on promising new immunotherapies beyond the currently available treatment options for malignant melanoma, including oncolytic immunotherapy, selective inhibitors of indoleamine 2,3-dioxygenease, anti-PD-(L)1 (programmed death ligand 1) drugs, immune checkpoint protein LAG-3 antibodies, inhibitors of histone deacetylase (HDAC) and inhibitors of B7-H3.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Journal, Oncolytic Virus, Checkpoint inhibition, PD(L)-1 Biomarker, IO Biomarker:  Triple threat to cancer: rationale for combining oncolytic viruses, MEK inhibitors, and immune checkpoint blockade. (Pubmed Central) -  Mar 26, 2019   
    In a recent edition of Science Translational Medicine, we identified an enhanced therapeutic activity when talimogene laherparepvec (T-VEC) was combined with MEK inhibition in murine melanoma tumor models...Combination therapy increased PD-1/PD-L1 expression and PD-1 blockade further enhanced tumor regression. Further clinical development of this strategy for treating melanomas warranted.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  TVEC and Preop Radiation for Sarcoma (4 ml Dose) (clinicaltrials.gov) -  Mar 19, 2019   
    P1/2,  N=30, Active, not recruiting, 
    Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Apr 2020 --> Oct 2023 | Trial primary completion date: Apr 2020 --> Jan 2019
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Trial completion date, Trial primary completion date, Metastases:  Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors (clinicaltrials.gov) -  Mar 8, 2019   
    P1,  N=18, Recruiting, 
    Disease control is seen in the vast majority. Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Feb 2020 --> Feb 2022
  • ||||||||||  Provecta (rose bengal sodium) / Provectus
    Enrollment closed, Trial completion date, Trial primary completion date, Oncolytic virus, Metastases:  PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma (clinicaltrials.gov) -  Dec 7, 2018   
    P3,  N=225, Active, not recruiting, 
    Trial primary completion date: Dec 2018 --> Jul 2022 Recruiting --> Active, not recruiting | Trial completion date: Oct 2018 --> Apr 2019 | Trial primary completion date: Sep 2018 --> Mar 2019
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Trial completion date:  Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma (clinicaltrials.gov) -  Dec 5, 2018   
    P1b/2,  N=217, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Oct 2018 --> Apr 2019 | Trial primary completion date: Sep 2018 --> Mar 2019 Trial completion date: Feb 2019 --> Feb 2021