The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
Official Title: A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
Study ID: NCT03313778
Brief Summary: The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors.
Detailed Description: This is a multi-part, dose-escalation study of mRNA-4157 monotherapy in participants with resected solid tumors (Part A), mRNA-4157 monotherapy lead-in and then in combination with standard of care (SoC) adjuvant chemotherapy followed by mRNA-4157 monotherapy in participants with resected pancreatic ductal adenocarcinoma (PDAC) (Part A2), mRNA-4157 in combination with pembrolizumab in participants with both unresectable (locally advanced or metastatic) solid tumors (Parts B and C) and adjuvant resected cutaneous melanoma (Part D), and mRNA-4157 in combination with pembrolizumab and SoC chemotherapy in peri-operative setting in participants with non-squamous non-small cell lung cancer (NSCLC) (Part E1), squamous cell NSCLC (Part E2), and gastric/ gastroesophageal (GEJ) cancer (Part E3). Parts A and B will include a dose escalation phase of the study to identify doses of mRNA-4157 for the expansion phase of the study. Doses of mRNA-4157 will be administered to participants in a dose escalation regimen. Participants in Parts A2, B, C, D, E1, E2 and E3 dose expansion phase will receive mRNA-4157 at a recommended dose for expansion.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona, Tucson, Arizona, United States
Florida Cancer Specialists, Sarasota, Florida, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
John Theurer Cancer Center, Hackensack, New Jersey, United States
NYU Langone, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Sarah Cannon Research Institute, Tennessee Oncology, Nashville, Tennessee, United States
Westmead Hospital-Cnr Hawkesbury and Darcy Road, Westmead, , Australia