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
NCT ID: NCT04274907
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2020-06-30
2021-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Venetoclax and Irinotecan in Relapsed/Refractory SCLC
NCT04543916
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
NCT02117024
Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
NCT00145418
S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
NCT00946712
A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
NCT07221474
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose Escalation Phase: Venetoclax + Pembrolizumab
Participants will receive escalating doses of venetoclax in combination with pembrolizumab Dose A.
Venetoclax
Tablet: Oral
Pembrolizumab
Intravenous (IV) Infusion
Randomization Phase: Venetoclax + Pembrolizumab
Participants will receive venetoclax at dose levels determined in the dose escalation phase in combination with pembrolizumab Dose A.
Venetoclax
Tablet: Oral
Pembrolizumab
Intravenous (IV) Infusion
Randomization Phase: Pembrolizumab Monotherapy
Participants will receive pembrolizumab Dose A
Pembrolizumab
Intravenous (IV) Infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Venetoclax
Tablet: Oral
Pembrolizumab
Intravenous (IV) Infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
* High PD-L1 tumor expression (tumor proportion score \>= 50%) as determined by a Food and Drug Administration (FDA)-approved test.
* Willing to provide tissue biopsy sample prior to start of study.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria
* History of or ongoing interstitial lung disease or pneumonitis that required oral or intravenous (IV) steroids.
* Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a participant has signs/symptoms suggestive of SARS-CoV-2 infection, they should undergo molecular (e.g., polymerase chain reaction \[PCR\]) testing to rule out SARS-CoV-2 infection.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
St 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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M19-700
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.