PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: Patients eligible for inclusion in this study have 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). - Expansion Cohorts only: Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Exceptions may be considered after discussion with the sponsor. Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria: - History of severe hypersensitivity reactions to other mAbs. - 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. Other protocol-defined inclusion/exclusion criteria may apply.

Locations & Contacts

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Contact: Suzanne Marie Bailey
Phone: 317-278-4694
Email: subailey@iupui.edu

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
MedStar Franklin Square Medical Center / Weinberg Cancer Institute
Status: Active
Name Not Available

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: In review
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Temporarily closed to accrual
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CPDR001XUS01
Secondary IDs NCI-2018-00157
Clinicaltrials.gov ID NCT03365791