PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
NCT ID: NCT03365791
Last Updated: 2022-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2018-01-24
2020-09-17
Brief Summary
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Detailed Description
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Participants were treated with the combination of PDR001 300 mg with LAG525 400 mg once every 3 weeks (Q3W) via intravenous (i.v.) infusion. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma criteria (Cheson et al 2007)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PDR001+LAG525
PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001.
PDR001
PDR001 is a high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.
LAG525
LAG525 is a high-affinity, ligand-blocking, humanized anti-LAG-3 IgG4 antibody which blocks the binding of the known LAG-3 ligand MHC class II to LAG-3.
Interventions
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PDR001
PDR001 is a high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.
LAG525
LAG525 is a high-affinity, ligand-blocking, humanized anti-LAG-3 IgG4 antibody which blocks the binding of the known LAG-3 ligand MHC class II to LAG-3.
Eligibility Criteria
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Inclusion Criteria
* Patient must have had at least one prior line of therapy for their disease and must not be beyond 4th progression/relapse of disease (5 maximum prior lines).
* Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the section "condition". Patients must have measurable disease as per appropriate guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised Response Criteria for Malignant Lymphoma - Cheson et al 2007).
Exclusion Criteria
* History of severe hypersensitivity reactions to other monoclonal antibodies.
* Impaired cardiac function or clinically significant cardiac disease.
* Active, known or suspected autoimmune disease or a documented history of autoimmune disease within three years prior to screening with a few exceptions as per protocol.
* Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
* Patient with second primary malignancy within \< 3 years of first dose of study treatment.
* Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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California Pacific Medical Center Drug Shipment (2)
San Francisco, California, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
University Cancer and Blood Center, LLC
Athens, Georgia, United States
Northwestern University Medical School
Chicago, Illinois, United States
University of Illinois Cancer Center at Chicago SC
Chicago, Illinois, United States
Illinois Cancer Care P.C. Jesse Brown VA
Peoria, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics Comprehensive Cancer Center
Iowa City, Iowa, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
Weinberg Cancer Institute at Franklin Square Hospital
Baltimore, Maryland, United States
Billings Clinic Dept of Billings Clinic(2)
Billings, Montana, United States
Oncology Hematology West Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers
Las Vegas, Nevada, United States
Oregon Health and Science University
Portland, Oregon, United States
Oncology Consultants Oncology Consultants
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System SC
Lacey, Washington, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novctrd.com
Other Identifiers
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CPDR001XUS01
Identifier Type: -
Identifier Source: org_study_id
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