Spots Global Cancer Trial Database for Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611
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Trial Identification
Brief Title: Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611
Official Title: A Phase 1b/2, Multicenter, Open-label, Basket Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Liver Tumors Alone and in Combination With Systemic Pembrolizumab in Phase 1b and to Evaluate the Efficacy and Safety of Intratumoral Talimogene Laherparepvec in Combination With Systemic Pembrolizumab to Treat Subjects With Advanced Solid Tumors in Phase 2 (MASTERKEY-318)
Study ID: NCT02509507
Study Description
Brief Summary: This is a phase 1b/2, multicenter, open-label, basket trial to evaluate the safety of talimogene laherparepvec injected intrahepatically into liver tumors alone and in combination with systemic intravenous (IV) administration of pembrolizumab, in subjects with non-hepatocellular carcinoma (HCC) liver metastases from breast adenocarcinoma (BC), colorectal adenocarcinoma (CRC), gastroesophageal cancer (GEC), melanoma, non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (RCC) in Part 1 Group A, and subjects with HCC with and without viral hepatitis in Part 1 Group B (viral hepatitis is only applicable in combination setting), and to evaluate the efficacy and safety of intratumoral talimogene laherparepvec in combination with systemic pembrolizumab in subjects with advanced triple negative breast cancer (TNBC), hormone receptor positive breast cancer, CRC, cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC) in Part 2 Group A and subjects with HCC with and without viral hepatitis in Part 2 Group B. The objective of Part 1 is to evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver tumors alone and in combination with systemically administered pembrolizumab for the non-HCC (Group A) and HCC (Group B) cohorts separately. Part 2 consists of 2-stage design to evaluate the efficacy and safety of talimogene laherparepvec in combination with systemic pembrolizumab. Efficacy and safety will be evaluated in each of the five non-HCC tumor types from Group A separately. Similarly, the efficacy and safety of the combination treatment will be determined for Group B HCC subjects. As of Protocol Amendment 6 (dated 26 October 2021), intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study. Enrollment for this study has stopped.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth Research Institute, Scottsdale, Arizona, United States
University of California Los Angeles, Santa Monica, California, United States
Georgetown-Howard University Center for Clinical Translational Science, Washington, District of Columbia, United States
University of Louisville James Graham Brown Cancer Center, Louisville, Kentucky, United States
Washington University School of Medicine, Center for Advanced Medicine, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Liverpool Hospital, Liverpool, New South Wales, Australia
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Tasman Oncology Research, Southport, Queensland, Australia
Landeskrankenhaus Salzburg, Salzburg, , Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum, Berlin, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Kreiskliniken Reutlingen - Klinikum am Steinenberg, Reutlingen, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Cha Bundang Medical Center, Cha University, Seongnam-si, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Hopitaux Universitaires de Geneve, Geneva 14, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Universitaetsspital Zuerich, Zurich, , Switzerland
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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