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23 Diseases |  |
21 Trials |
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21 Trials |  |
1283 News |  |
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- | Imlygic (talimogene laherparepvec) / Amgen
Enrollment change, Surgery: Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - Oct 2, 2018
P2, N=35, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
N=10 --> 35
- | Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS
Trial initiation date: A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion (clinicaltrials.gov) - Sep 24, 2018
P1/2, N=24, Not yet recruiting, Sponsor: UNC Lineberger Comprehensive Cancer Center
N=10 --> 35 Initiation date: Sep 2018 --> Dec 2018
- | Imlygic (talimogene laherparepvec) / Amgen
New P1 trial: TEMPO: Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies (clinicaltrials.gov) - Sep 9, 2018
P1, N=24, Not yet recruiting, Sponsor: Dan Blazer III, M.D.
- | Imlygic (talimogene laherparepvec) / Amgen
Clinical, P3 data, Journal: Phase IIIb safety results from an expanded-access protocol of talimogene laherparepvec for patients with unresected, stage IIIB-IVM1c melanoma. (Pubmed Central) - Aug 19, 2018
In the clinical practice setting, talimogene laherparepvec has a safety profile comparable to that observed in previous clinical trials. Talimogene laherparepvec (IMLYGIC) is now approved in the US, European Union, and Australia.
- | Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, Metastases: MASTERKEY 232: Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137) (clinicaltrials.gov) - Jul 30, 2018
P1b, N=36, Active, not recruiting, Sponsor: Amgen
Talimogene laherparepvec (IMLYGIC) is now approved in the US, European Union, and Australia. Trial completion date: Jun 2023 --> Aug 2020 | Trial primary completion date: Oct 2021 --> Nov 2017
- || Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS
New P1/2 trial: A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion (clinicaltrials.gov) - Jul 24, 2018
P1/2, N=24, Not yet recruiting, Sponsor: UNC Lineberger Comprehensive Cancer Center
- | Imlygic (talimogene laherparepvec) / Amgen
Trial completion date: Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma (clinicaltrials.gov) - Jul 18, 2018
P2, N=112, Active, not recruiting, Sponsor: Amgen
Trial completion date: Jun 2023 --> Aug 2020 | Trial primary completion date: Oct 2021 --> Nov 2017 Trial completion date: Jun 2018 --> Dec 2018
- | Imlygic (talimogene laherparepvec) / Amgen
New P1/2 trial, Combination therapy, Metastases: TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion) (clinicaltrials.gov) - Jul 15, 2018
P1/2, N=15, Recruiting, Sponsor: Royal Marsden NHS Foundation Trust
- | Imlygic (talimogene laherparepvec) / Amgen
Journal: Dermoscopic Guidance of Talimogene Laherparepvec Injection for Metastatic Melanoma. (Pubmed Central) - Jul 7, 2018
Trial completion date: Jun 2018 --> Dec 2018 No abstract available
- | Imlygic (talimogene laherparepvec) / Amgen
Enrollment open, Surgery, Metastases: Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer (clinicaltrials.gov) - Jul 6, 2018
P1, N=21, Recruiting, Sponsor: National Cancer Institute (NCI)
No abstract available Suspended --> Recruiting
- || Imlygic (talimogene laherparepvec) / Amgen
Trial initiation date: T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer (clinicaltrials.gov) - Jul 2, 2018
P1b, N=25, Not yet recruiting, Sponsor: University of California, San Francisco
Suspended --> Recruiting Initiation date: Jun 2018 --> Dec 2018
- | Imlygic (talimogene laherparepvec) / Amgen
Enrollment open, Combination therapy, Metastases: TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion) (clinicaltrials.gov) - Jun 28, 2018
P1/2, N=15, Recruiting, Sponsor: Royal Marsden NHS Foundation Trust
Initiation date: Jun 2018 --> Dec 2018 Not yet recruiting --> Recruiting
- || Imlygic (talimogene laherparepvec) / Amgen
New P1 trial: T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer (clinicaltrials.gov) - Jun 11, 2018
P1b, N=25, Not yet recruiting, Sponsor: University of California, San Francisco
- ||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion, Trial completion date: Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec (clinicaltrials.gov) - Jun 6, 2018
P2, N=61, Completed, Sponsor: Amgen
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Aug 2018 --> Apr 2018
- | Imlygic (talimogene laherparepvec) / Amgen
Clinical, Journal, Oncolytic virus: Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials. (Pubmed Central) - May 23, 2018
P3
Active, not recruiting --> Completed | Trial completion date: Aug 2018 --> Apr 2018 Achieving a DR was associated with clinical benefits such as improved OS and QoL and prolonged TFI, thus supporting the usefulness of DR as a meaningful immunotherapy clinical trial endpoint.
- | Imlygic (talimogene laherparepvec) / Amgen
Trial suspension, Surgery, Metastases: Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer (clinicaltrials.gov) - Apr 30, 2018
P1, N=21, Suspended, Sponsor: National Cancer Institute (NCI)
Achieving a DR was associated with clinical benefits such as improved OS and QoL and prolonged TFI, thus supporting the usefulness of DR as a meaningful immunotherapy clinical trial endpoint. Recruiting --> Suspended
- || Imlygic (talimogene laherparepvec) / Amgen
Phase classification: Registry Study for Talimogene Laherparepvec (clinicaltrials.gov) - Apr 6, 2018
P, N=340, Enrolling by invitation, Sponsor: Amgen
Recruiting --> Suspended Phase classification: P=N/A --> P
- || Imlygic (talimogene laherparepvec) / Amgen
Phase classification: Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC (clinicaltrials.gov) - Mar 30, 2018
P, N=920, Recruiting, Sponsor: Amgen
Phase classification: P=N/A --> P Phase classification: P=N/A --> P
- Imlygic (talimogene laherparepvec) / Amgen
Enrollment open, Combination therapy: Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases (clinicaltrials.gov) - Mar 30, 2018
P1b, N=36, Recruiting, Sponsor: Amgen
Phase classification: P=N/A --> P Not yet recruiting --> Recruiting
- Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date, Metastases: TVEC and Preop Radiation for Sarcoma (4 ml Dose) (clinicaltrials.gov) - Mar 22, 2018
P1/2, N=32, Recruiting, Sponsor: Mohammed M Milhem
Not yet recruiting --> Recruiting Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2018 --> Apr 2020
- || Imlygic (talimogene laherparepvec) / Amgen
Trial completion date: Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec (clinicaltrials.gov) - Mar 8, 2018
P2, N=61, Active, not recruiting, Sponsor: Amgen
Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2018 --> Apr 2020 Trial completion date: Feb 2018 --> Aug 2018
- Imlygic (talimogene laherparepvec) / Amgen
Trial initiation date, Metastases: Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer (clinicaltrials.gov) - Mar 8, 2018
P1, N=16, Recruiting, Sponsor: Yvonne Saenger
Trial completion date: Feb 2018 --> Aug 2018 Initiation date: Nov 2017 --> Nov 2017
- | Imlygic (talimogene laherparepvec) / Amgen
New P1 trial, Metastases: T-VEC in Non-melanoma Skin Cancer (clinicaltrials.gov) - Mar 8, 2018
P1, N=20, Not yet recruiting, Sponsor: University of Zurich
- | Imlygic (talimogene laherparepvec) / Amgen
Trial completion date: KEYNOTE-034: Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma (clinicaltrials.gov) - Mar 5, 2018
P1b, N=660, Recruiting, Sponsor: Amgen
Initiation date: Nov 2017 --> Nov 2017 Trial completion date: Sep 2022 --> Mar 2023
- Imlygic (talimogene laherparepvec) / Amgen
Trial initiation date, Combination therapy: Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases (clinicaltrials.gov) - Mar 5, 2018
P1b, N=36, Not yet recruiting, Sponsor: Amgen
Trial completion date: Sep 2022 --> Mar 2023 Initiation date: Mar 2018 --> Apr 2018
- Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial initiation date, Combination therapy: Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases (clinicaltrials.gov) - Mar 3, 2018
P1b, N=36, Not yet recruiting, Sponsor: Amgen
Initiation date: Mar 2018 --> Apr 2018 Trial completion date: Apr 2021 --> May 2021 | Initiation date: Feb 2018 --> Mar 2018
- | Imlygic (talimogene laherparepvec) / Amgen
New P1 trial: NCI-2018-00109: Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma (clinicaltrials.gov) - Feb 13, 2018
P1, N=30, Not yet recruiting, Sponsor: University of California, San Francisco
- ||| Imlygic (talimogene laherparepvec) / Amgen
Phase classification, Enrollment change, Pan tumor, Metastases: MASTERKEY318: Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611 (clinicaltrials.gov) - Feb 12, 2018
P1b/2, N=244, Recruiting, Sponsor: Amgen
Trial completion date: Apr 2021 --> May 2021 | Initiation date: Feb 2018 --> Mar 2018 Phase classification: P1 --> P1b/2 | N=100 --> 244
- | Imlygic (talimogene laherparepvec) / Amgen
P3 data, Journal: Cutaneous head and neck melanoma in OPTiM, a randomized phase 3 trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor for the treatment of unresected stage IIIB/IIIC/IV melanoma. (Pubmed Central) - Feb 11, 2018
Phase classification: P1 --> P1b/2 | N=100 --> 244 Treatment with talimogene laherparepvec was associated with improved response and survival compared with GM-CSF in patients with cutaneous head and neck melanoma.
- | Imlygic (talimogene laherparepvec) / Amgen
Clinical, P3 data, Journal: Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial. (Pubmed Central) - Jan 31, 2018
Responses in uninjected lesions provide validation of T-VEC-induced systemic immunotherapeutic effects against melanoma. PPR did not negatively impact the clinical effectiveness of T-VEC.
- || ontorpacept intratumoral (TTI 621 intratumoral) / Pfizer
Enrollment change: Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides (clinicaltrials.gov) - Jan 29, 2018
P1, N=240, Recruiting, Sponsor: Trillium Therapeutics Inc.
PPR did not negatively impact the clinical effectiveness of T-VEC. N=54 --> 240
- Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Enrollment change, Surgery: Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - Jan 24, 2018
P2, N=10, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
N=54 --> 240 Recruiting --> Active, not recruiting | N=35 --> 10
- Imlygic (talimogene laherparepvec) / Amgen
Enrollment closed, Metastases: MASTERKEY 232: Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137) (clinicaltrials.gov) - Jan 24, 2018
P1b, N=40, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting | N=35 --> 10 Recruiting --> Active, not recruiting
- | Imlygic (talimogene laherparepvec) / Amgen
Review, Journal, Oncolytic Virus: Review: Oncolytic virotherapy, updates and future directions. (Pubmed Central) - Dec 20, 2017
IMLYGIC™ (T-VEC/Talimogene Laherparepvec), a genetically engineered Herpes Simplex Virus, is the first OV approved for use in the United States and the European Union for patients with locally advanced or non-resectable melanoma...Also for immune checkpoint inhibition to be effective in treating cancer, an immune response to tumor neoantigens and an inflamed tumor microenvironment are required, both of which treatment with an OV may provide. Therefore, direct and indirect mechanisms of tumor killing provide rationale for clinical trials investigating the combination of OVs other forms of cancer therapy, including immune checkpoint inhibition.
- Imlygic (talimogene laherparepvec) / Amgen
Enrollment open, Trial initiation date, Metastases: Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer (clinicaltrials.gov) - Oct 16, 2017
P1, N=16, Recruiting, Sponsor: Yvonne Saenger
Therefore, direct and indirect mechanisms of tumor killing provide rationale for clinical trials investigating the combination of OVs other forms of cancer therapy, including immune checkpoint inhibition. Not yet recruiting --> Recruiting | Initiation date: Apr 2017 --> Nov 2017
- || Imlygic (talimogene laherparepvec) / Amgen
Enrollment change: Registry Study for Talimogene Laherparepvec (clinicaltrials.gov) - Oct 9, 2017
P=N/A, N=340, Enrolling by invitation, Sponsor: Amgen
Not yet recruiting --> Recruiting | Initiation date: Apr 2017 --> Nov 2017 N=450 --> 340
- Imlygic (talimogene laherparepvec) / Amgen
Trial initiation 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) - Oct 6, 2017
P1b, N=36, Not yet recruiting, Sponsor: Amgen
N=450 --> 340 Initiation date: Sep 2017 --> Feb 2018 | Trial primary completion date: Feb 2019 --> Jun 2019
- | Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker, Metastases: S1607: Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov) - Oct 5, 2017
P2, N=64, Recruiting, Sponsor: National Cancer Institute (NCI)
Initiation date: Sep 2017 --> Feb 2018 | Trial primary completion date: Feb 2019 --> Jun 2019 Not yet recruiting --> Recruiting
- | Imlygic (talimogene laherparepvec) / Amgen, Opdivo (nivolumab) / BMS
Enrollment open, PD(L)-1 Biomarker, IO biomarker: NCI#10057: Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers (clinicaltrials.gov) - Oct 3, 2017
P2, N=68, Recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Imlygic (talimogene laherparepvec) / Amgen
New P1 trial, Surgery, Metastases: Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer (clinicaltrials.gov) - Oct 3, 2017
P1, N=21, Recruiting, Sponsor: National Cancer Institute (NCI)
- | Imlygic (talimogene laherparepvec) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Journal: Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy. (Pubmed Central) - Sep 29, 2017
These findings suggest that oncolytic virotherapy may improve the efficacy of anti-PD-1 therapy by changing the tumor microenvironment. VIDEO ABSTRACT.
- Imlygic (talimogene laherparepvec) / Amgen
Enrollment open, Metastases: Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors (clinicaltrials.gov) - Aug 28, 2017
P1, N=18, Recruiting, Sponsor: Amgen
VIDEO ABSTRACT. Not yet recruiting --> Recruiting
- ||| Imlygic (talimogene laherparepvec) / Amgen
Enrollment open: Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC (clinicaltrials.gov) - Aug 25, 2017
P=N/A, N=920, Recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Imlygic (talimogene laherparepvec) / Amgen
Journal: Intratumoral Approaches for the Treatment of Melanoma. (Pubmed Central) - Aug 24, 2017
This review will focus on the rationale for intratumoral treatment in melanoma, describe the clinical and safety data for some of the agents in clinical development, and provide a perspective for future clinical investigation with intratumoral approaches. Melanoma has been a paradigm tumor for progress in targeted therapy and immunotherapy and will likely also be the tumor to establish the therapeutic role of intratumoral treatment for cancer.
- | Imlygic (talimogene laherparepvec) / Amgen
Trial suspension, IO biomarker, Surgery: Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery (clinicaltrials.gov) - Aug 24, 2017
P2, N=40, Suspended, Sponsor: National Cancer Institute (NCI)
Melanoma has been a paradigm tumor for progress in targeted therapy and immunotherapy and will likely also be the tumor to establish the therapeutic role of intratumoral treatment for cancer. Not yet recruiting --> Suspended
- | Imlygic (talimogene laherparepvec) / Amgen
New P1 trial, Combination therapy: Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases (clinicaltrials.gov) - Aug 21, 2017
P1b, N=36, Not yet recruiting, Sponsor: Amgen
- | Imlygic (talimogene laherparepvec) / Amgen, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal: Talimogene Laherparepvec in Combination With Ipilimumab in Previously Untreated, Unresectable Stage IIIB-IV Melanoma. (Pubmed Central) - Jul 29, 2017
Not yet recruiting --> Suspended T-VEC with ipilimumab had a tolerable safety profile, and the combination appeared to have greater efficacy than either T-VEC or ipilimumab monotherapy.
- || Imlygic (talimogene laherparepvec) / Amgen
Trial primary completion date, Pan tumor, Metastases: MASTERKEY318: Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611 (clinicaltrials.gov) - Jun 28, 2017
P1, N=100, Recruiting, Sponsor: Amgen
T-VEC with ipilimumab had a tolerable safety profile, and the combination appeared to have greater efficacy than either T-VEC or ipilimumab monotherapy. Trial primary completion date: Apr 2018 --> Sep 2021
- Enrollment open, Combination therapy, Metastases: Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma (clinicaltrials.gov) - Jun 27, 2017
P1b, N=20, Recruiting, Sponsor: West Cancer Center
Trial primary completion date: Apr 2018 --> Sep 2021 Not yet recruiting --> Recruiting
- | Imlygic (talimogene laherparepvec) / Amgen
Review, Journal: Review: Oncolytic Virotherapy, updates and future directions. (Pubmed Central) - Jun 16, 2017
IMLYGIC™ (T-VEC/Talimogene Laherparepvec), a genetically engineered Herpes Simplex Virus, is the first OV approved for use in the United States and the European Union for patients with locally advanced or non-resectable melanoma.Although OVs have a favorable toxicity profile and are impressively active anticancer agents in vitro and in vivo the majority of OVs have limited clinical efficacy as a single agent...Also for immune checkpoint inhibition to be effective in treating cancer, an immune response to tumor neoantigens and an inflamed tumor microenvironment are required, both of which treatment with an OV may provide. Therefore, direct and indirect mechanisms of tumor killing provide rationale for clinical trials investigating the combination of OVs other forms of cancer therapy, including immune checkpoint inhibition.