Clinical Trials

Below is a list of currently active Phase II, III and IV trials. You can also search for a specific clinical trial using the field provided above.

  • Javelin- Gastric 100

    The primary objective of this trial is to demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to Overall Survival (OS) in subjects who have not progressed on first-line chemotherapy Secondary objectives:  To demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to Progression-free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).  To demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to objective response rate (ORR) as per RECIST v1.1.  To compare the subject-reported outcomes / quality of life of subjects when treated with avelumab versus continuation of first-line chemotherapy as assessed by the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ-5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ-STO22  To determine the safety and tolerability of avelumab Exploratory objectives  To evaluate tumor shrinkage in target lesions at each time point from baseline  To evaluate PD-L1 expression levels in tumor cells and cells of the tumor microenvironment (for example, infiltrating lymphocytes) as candidate predictive biomarker with their relation to selected clinical response parameters  To determine duration of response  To determine time to response  To characterize population pharmacokinetics (PK) of avelumab and individual drug exposures based on sparse PK sampling  To characterize exposure response (exposure safety and exposure efficacy) for avelumab with respect to selected safety and efficacy endpoints  To explore molecular, cellular, and soluble markers (for example, but not limited to changes in gene expression profiles, microsatellite instability status, tumor-infiltrating lymphocytes and cytokine levels) in peripheral blood and/or tumor tissue that may be relevant to the mechanism of action of, or response/resistance to avelumab  To characterize the immunogenicity of avelumab.

  • CheckMate 627

    To evaluate the clinical benefit rate of nivolumab at week 16 (CBR16) in advanced or metastatic malignancies

  • Testing whether avoiding the hippocampus in addition to memantine

    Primary Objective Determine whether the addition of HA-WBRT increases time to neurocognitive failure at months 2, 4, 6 and 12 as measured by neurocognitive decline on a battery of tests: the Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. 1.2 Secondary Objectives 1.2.1 Determine whether the addition of HA-WBRT preserves neurocognitive function at months 2, 4, 6 and 12 as separately measured by each test, the HVLT-R for Total Recall, Delayed Recall, and Delayed Recognition; COWA; and TMT Parts A and B. 1.2.2 Evaluate the potential benefit of HA-WBRT in symptom burden, as measured by the M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) 1.2.3 Assessment of quality adjusted survival and health outcomesusing the EQ-5D-5L. 1.2.4 Compare cumulative incidence of progression and overall survival after WBRT versus HA-WBRT. 1.2.5 Compare adverse events between the treatment arms according to the CTCAE v4.0 criteria.

  • Open-Label Extension and Safety Study of Talazoparib

    To offer extended open-label treatment to patients treated with talazoparib in qualifying studies To obtain additional safety data on talazoparib use

  • Phase I Open-Label of Talazoparib on Cardiac Patients

    To evaluate the effect of talazoparib on cardiac repolarization in patients with advanced solid tumors by assessing the QTc To assess the relationship between plasma talazoparib concentrations and the QTc

  • Whole-Brain Radiation Therapy With or Without Hippocampal Avoidan

    This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

  • Phase I Open-Label Pharmacokinetics and Safety of Talazoparib

    To investigate the effect of mild, moderate or severe hepatic impairment on the PK of talazoparib following daily oral dosing for 22 consecutive days, in patients with advanced solid tumors.

  • Ubenimex in Adult Patients With Secondary Lymphedema of The Lower

    To evaluate the efficacy of ubenimex in patients with secondary leg lymphedema To evaluate the safety and tolerability of ubenimex in patients with secondary leg lymphedema

  • Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Loc

    Determine the Clinical Benefit Rate (CBR) at 24 weeks amongst patients receiving triple therapy with ribociclib + everolimus + exemestane, for advanced/metastatic HR+, HER2-negative breast cancer following progression on CDK 4/6 inhibitor.

  • A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Local

    The primary objective of this study is to compare the efficacy of abemaciclib plus trastuzumab plus fulvestrant and abemaciclib plus trastuzumab to standard-of-care single-agent chemotherapy of physician’s choice plus trastuzumab with respect to progression free survival (PFS).