PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
Modular Phase 2 Study to Link Combination Immune-therapy to Patients With Advanced Solid and Hematologic Malignancies. Module 9: PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies.
1 other identifier
interventional
76
1 country
20
Brief Summary
The purpose of this signal seeking study is to determine whether treatment with PDR001 and LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2018
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
January 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2020
CompletedResults Posted
Study results publicly available
April 19, 2021
CompletedMay 27, 2022
May 1, 2022
1.1 years
November 20, 2017
March 24, 2021
May 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma
CBR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. CBR (CR+PR+SD) is reported overall and by tumor type.
24 weeks
Secondary Outcomes (8)
Overall Response Rate (ORR)
From start of treatment until end of treatment, assessed up to 113 weeks
Time to Response (TTR)
From start of treatment to the first documented response of either complete response or partial response, assessed up to 113 weeks
Duration of Response (DOR)
From first documented response (CR or PR) to first documented progression or death, assessed up to 113 weeks
Time to Progression (TTP)
From start of treatment to first documented progression or death due to underlying cancer, assessed up to 113 weeks
Progression-Free Survival (PFS)
From start of treatment to first documented progression or death, assessed up to 113 weeks
- +3 more secondary outcomes
Study Arms (1)
PDR001+LAG525
EXPERIMENTALPDR001 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.
Interventions
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 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
You may qualify if:
- 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).
You may not qualify if:
- Patients eligible for this study must not meet any of the following 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
California Pacific Medical Center Drug Shipment (2)
San Francisco, California, 94120-7999, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
University Cancer and Blood Center, LLC
Athens, Georgia, 30607, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
University of Illinois Cancer Center at Chicago SC
Chicago, Illinois, 60612, United States
Illinois Cancer Care P.C. Jesse Brown VA
Peoria, Illinois, 61615-7828, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
Weinberg Cancer Institute at Franklin Square Hospital
Baltimore, Maryland, 21237-3998, United States
Billings Clinic Dept of Billings Clinic(2)
Billings, Montana, 59101, United States
Oncology Hematology West Nebraska Cancer Specialists
Omaha, Nebraska, 68124, United States
Comprehensive Cancer Centers
Las Vegas, Nevada, 89169, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Oncology Consultants Oncology Consultants
Houston, Texas, 77024, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Providence Regional Cancer System SC
Lacey, Washington, 98503, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2017
First Posted
December 7, 2017
Study Start
January 24, 2018
Primary Completion
February 21, 2019
Study Completion
September 17, 2020
Last Updated
May 27, 2022
Results First Posted
April 19, 2021
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.