PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
Condition: 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
MeSH terms: Lymphoma; Adenocarcinoma; Neoplasms; Sarcoma; Lymphoma, B-Cell; Small Cell Lung Carcinoma; Lymphoma, Large B-Cell, Diffuse; Neuroendocrine Tumors; Hematologic Neoplasms
Intervention: PDR001; LAG525
Intervention description: 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.
Intervention MeSH terms: Spartalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is 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 available standard of care therapies. Patients will receive study treatment for a maximum of 2 years. All disease assessments will be performed locally by the investigator.
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PDR001; LAG525; Immune checkpoint blockade; Solid tumor malignancy; lymphoma; Small cell lung cancer (SCLC); Gastric/esophageal adenocarcinoma; Castration resistant prostate adenocarcinoma (CRPC); Soft tissue sarcoma; Ovarian adenocarcinoma; Advanced well-differentiated neuroendocrine tumors (NETs); Diffuse large B cell lymphoma (DLBCL)

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.
    

Eligibility criteria:

        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.