Status:
COMPLETED
PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Small Cell Lung Cancer
Gastric Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
This was a phase II, open-label study to determine the efficacy and safety of treatment with the combination of PDR001+LAG525 across multiple tumor types that are relapsed and/or refractory to availab...
Eligibility Criteria
Inclusion
- Patients eligible for inclusion in this study had to meet all of the following 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
- 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.
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03365791
Start Date
January 24 2018
End Date
September 17 2020
Last Update
May 27 2022
Active Locations (20)
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1
California Pacific Medical Center Drug Shipment (2)
San Francisco, California, United States, 94120-7999
2
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
3
University Cancer and Blood Center, LLC
Athens, Georgia, United States, 30607
4
Northwestern University Medical School
Chicago, Illinois, United States, 60611