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Spots Global Cancer Trial Database for LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

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Trial Identification

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

Conditions

Melanoma

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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