PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies

Completed · Phase 2

Conditions studied: Small Cell Lung Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Castration Resistant Prostate Adenocarcinoma, Soft Tissue Sarcoma, Ovarian Adenocarcinoma, Advanced Well-differentiated Neuroendocrine Tumors, Diffuse Large B Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT03365791

Run by

Novartis Pharmaceuticals

People needed

76

Starts

2018-01-24

Expected to finish

2020-09-17

Last updated by the study team

2022-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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