Spots Global Cancer Trial Database for A Safety Study of Oral Venetoclax in Combination With Intravenous Pembrolizumab in Adult Participants With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) With High Programmed Cell Death Ligand-1 (PD-L1) Expression
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Trial Identification
Brief Title: A Safety Study of Oral Venetoclax in Combination With Intravenous Pembrolizumab in Adult Participants With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) With High Programmed Cell Death Ligand-1 (PD-L1) Expression
Official Title: A Phase 1b Study of Venetoclax in Combination With Pembrolizumab in Subjects With Previously Untreated NSCLC Whose Tumors Have High PD-L1 Expression
Study ID: NCT04274907
Study Description
Brief Summary: Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. It is the most common form of lung cancer, accounting for around 85% of lung cancers. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of venetoclax in combination with pembrolizumab in participants with NSCLC. Venetoclax is a drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. Pembrolizumab is approved drug for the treatment of NSCLC. It works with your immune system to help fight certain cancers. The study is split into two portions - dose escalation and randomization. Participants are assigned one of the three treatment groups to receive pembrolizumab alone or in combination with venetoclax. Each group receives a different treatment. Participants who are at least 18 years of age with a diagnosis of NSCLC will be enrolled. Around 100 participants will be enrolled in the study in approximately 44 sites across United States. Participants will receive intravenous (IV) infusion of pembrolizumab alone or in combination with oral venetoclax tablets. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Univ of Alabama at Birmingham /ID# 214180, Birmingham, Alabama, United States
Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 216984, Tucson, Arizona, United States
St Jude Hospital dba St Joseph /ID# 212360, Santa Rosa, California, United States
Icri /Id# 217071, Whittier, California, United States
AdventHealth Cancer Institute - Orlando /ID# 214444, Orlando, Florida, United States
Georgia Regents University /ID# 217109, Augusta, Georgia, United States
Rush University Medical Center /ID# 212448, Chicago, Illinois, United States
University of Chicago DCAM /ID# 214319, Chicago, Illinois, United States
Ingalls Memorial Hosp /ID# 214952, Harvey, Illinois, United States
Fort Wayne Medical Oncology /ID# 214954, Fort Wayne, Indiana, United States
Ashland-Bellefonte Cancer Ctr /ID# 218511, Ashland, Kentucky, United States
University of Louisville /ID# 215195, Louisville, Kentucky, United States
Central Maine Medical Center /ID# 216107, Lewiston, Maine, United States
Maryland Oncology Hematology /ID# 214131, Columbia, Maryland, United States
University of Massachusetts Ca /ID# 218744, Worcester, Massachusetts, United States
Karmanos Cancer Institute /ID# 216986, Detroit, Michigan, United States
Henry Ford Health System /ID# 216385, Detroit, Michigan, United States
Univ of Mississippi Med Ctr /ID# 216429, Jackson, Mississippi, United States
Washington University-School of Medicine /ID# 212355, Saint Louis, Missouri, United States
Methodist Estabrook Cancer Center /ID# 216910, Omaha, Nebraska, United States
University of Nebraska Medical Center /ID# 216754, Omaha, Nebraska, United States
Hackensack Univ Med Ctr /ID# 216484, Hackensack, New Jersey, United States
Atlantic Health System /ID# 217067, Morristown, New Jersey, United States
Overlook Medical Center /ID# 219108, Summit, New Jersey, United States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 218077, New York, New York, United States
Weill Cornell Medical Center /ID# 216911, New York, New York, United States
University of Cincinnati Cancer Institute /ID# 216800, Cincinnati, Ohio, United States
University Hospitals Cleveland /ID# 212241, Cleveland, Ohio, United States
The Ohio State University - The James /ID# 212298, Columbus, Ohio, United States
Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 215497, Portland, Oregon, United States
Allegheny General Hospital /ID# 214363, Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute - Faris /ID# 217946, Greenville, South Carolina, United States
Thompson Cancer Survival Ctr /ID# 217076, Knoxville, Tennessee, United States
Houston Methodist Hospital - Scurlock Tower /ID# 215481, Houston, Texas, United States
Utah Cancer Specialists /ID# 215496, Salt Lake City, Utah, United States
Virginia Cancer Specialists /ID# 214328, Fairfax, Virginia, United States
Massey Cancer Centre /ID# 212527, Richmond, Virginia, United States
Multicare Institute for Research and Innovation /ID# 217913, Tacoma, Washington, United States
Northwest Medical Specialties /ID# 218484, Tacoma, Washington, United States
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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