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Brief Title: LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma
Official Title: Lerapolturev (Formerly Known as PVSRIPO) With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma
Study ID: NCT04577807
Brief Summary: A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor.
Detailed Description: This multi-center, open-label, randomized, Phase 2 will investigate the efficacy and safety of lerapolturev alone (Arm 1) or in combination with an anti-PD-1 inhibitor (Arm 2). Following a 6 participant safety run-in period, up to approximately 50 participants with cutaneous melanoma who previously failed anti-PD-1/L1-based therapy will be randomized 1:1 to receive either lerapolturev or lerapolturev plus an anti-PD-1.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Research Institute, Scottsdale, Arizona, United States
Orlando Health U7 Health Cancer Center, Orlando, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Cancer Treatment Centers of America, Zion, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
University of Pittsburgh Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology -Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Virginia Commonwealth University, Richmond, Virginia, United States
West Virginia University Medical Center, Morgantown, West Virginia, United States