PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies (NCT03365791) | Clinical Trial Compass
CompletedPhase 2
PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
United States76 participantsStarted 2018-01-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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 Criteria:
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.
What they're measuring
1
Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma