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Brief Title: Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy
Official Title: Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy: A Study of Subjects Administered Anti-PD-1/Anti-PD-L1 Therapy That Are Experiencing Insufficient Response to Checkpoint Inhibitor Alone
Study ID: NCT03616834
Brief Summary: Phase 2, open-label study that will evaluate the safety, tolerability, antitumor activities.
Detailed Description: This Phase 2, open-label study will evaluate the safety, tolerability, antitumor activity, and pharmacokinetics (PK) of Tomivosertib (eFT-508) in subjects who have initiated anti-PD-1/anti-PD-L1 monotherapy and either developed progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on therapy or have undergone 12 weeks of anti-PD-1/anti-PD-L1 therapy with no evidence of partial response (PR) or complete response (CR).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona - Cancer Center, Tucson, Arizona, United States
Pacific Shores Medical Group, Long Beach, California, United States
Hoag Memorial Hospital Presbyterian, Los Angeles, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
St. Mary's Medical Center, San Francisco, California, United States
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
Columbus Regional Research Institute, Columbus, Georgia, United States
Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Indiana University Health Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States
Anne Arundel Medical Center, Annapolis, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Gabrail Cancer Center, Canton, Ohio, United States
Universty of Toledo Medical Center, Toledo, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Oncology Consultants, Houston, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
University of Wisconsin Clinical Science Center, Madison, Wisconsin, United States
Name: Lyon Gleich, MD
Affiliation: Medpace, Inc.
Role: STUDY_DIRECTOR