Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611
Completed · Phase 1/Phase 2
Conditions studied: Hepatocellular Carcinoma, Liver Metastases, Cutaneous or Subcutaneous Lymph Node, Liver Tumors
In brief
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.
Key facts
- Study ID
- NCT02509507
- Run by
- Amgen
- People needed
- 127
- Starts
- 2016-02-05
- Expected to finish
- 2023-07-11
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 D.C., 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 — St 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 — Brussels, Belgium
- Universitair Ziekenhuis Antwerpen — Edegem, Belgium
- Universitair Ziekenhuis Gent — Ghent, 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
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
- Cha Bundang Medical Center, Cha University — Seongnam-si, Gyeonggi-do, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Severance Hospital Yonsei University Health System — Seoul, South Korea
- Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain
Full record on ClinicalTrials.gov
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