This study is for patients who have been diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) whose disease improved or remained unchanged after receiving nivolumab or pembrolizumab and whose disease has now worsened. The investigational drug in this study is called ALT-803. Participants can expect to receive the study drug ALT-803 in combination with an approved drug called pembrolizumab or they will receive ALT-803 in combination with an approved drug called nivolumab. Participants will receive ALT-803 in combination with pembrolizumab if they have previously received pembrolizumab. They will receive ALT-803 in combination with nivolumab if they have previously received nivolumab. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with either pembrolizumab or nivolumab in patients with advanced or metastatic NSCLC that initially had improvement or no change in disease after receiving pembrolizumab or nivolumab and who now have disease worsening. Participation in this study should take approximately 24 months.
This study is for patients that have been diagnosed with a type of cancer called Acute Myeloid Leukemia (AML). The investigational drug in this study is ONO-7475. The purpose of this study is to see whether ONO-7475 slows down the growth of cells that cause cancers like leukemias such as AML. The estimated duration of study participation in Part A is 6 months. You can continue in the study as long as you are gaining benefit from the study treatment.
This study is for patients who have been diagnosed with extensive-stage small cell lung cancer (SCLC). This study is being conducted to test whether or not rovalpituzumab tesirine (SC16LD6.5) combined with nivolumab alone or with nivolumab and ipilimumab are useful treatments for small cell lung cancer, after at least one prior treatment has failed.The investigational drugs in this study are Rovalpituzumab Tesirine (SC16LD6.5), Nivolumab (BMS-936558, MDX1106, ONO-4538, Opdivo®), and Ipilimumab (MDX-010, Yervoy®) . If participants agree to take part in this study, their involvement will last for as long as their study doctor confirms their cancer is not getting worse and there have been no significant side effects. There is no limit to the number of cycles of study treatment participants can receive.
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy
The purpose of this study is to find out, as a main objective, at which doses RO6958688 (study drug) can be administered safely to subjects and what the side effects are. Additionally, the effects of RO6958688 in the subject's body, and particularly in the subject's tumor, will be evaluated. The study also aims to find out if RO6958688 can slow down the growth of tumors or stop the cancer, in subjects with locally advanced and/or metastatic solid tumors.
RO6958688 is an investigational study drug which means it has not been approved by the FDA.
Subjects will receive RO6958688 weekly for several weeks or once every three weeks for several weeks. Depending on when the subject will be enrolled into the study, they will receive RO6958688 according to one of 3 different dosing schedules. The dose to be received will depend upon the observations made in all patients who have received the RO6958688 before you. Approximately 180 subjects will enroll into this part of the study, approximately 10 will take part at MUSC. Dr. Lilly will be the Primary Investigator at MUSC.
The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for approximately 6 weeks in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. At least 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.
This study is for patients that have been diagnosed with Relapsed/Refractory Acute Myeloid Leukemia (AML) or in Newly Diagnosed Older (?65 Years) AML Subjects. The investigational drug in this study is Azacitidine (AZA) and Pembroluzimab (KEYTRUDA). The purpose of this study is to determine the safety, tolerability and efficacy of Azacitidine (AZA) in combination with Pembrolizumab (also known as KEYTRUDA TM) in relapsed and refractory acute myeloid leukemia (AML) subjects, and also in older (?65 years) newly diagnosed AML subjects who are not candidates for intensive induction chemotherapy. Participants can expect to be in this study for up to 2 1/2 years.
This study is for patients that have been diagnosed with diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma that has never been treated. The investigational drug in this study is denintuzumab mafodotin. The purpose of this study is to find out what the side effects are and whether it is more or less effective when it is given together with other drugs that are a standard approved treatment for use in patients with lymphoma (DLBCL or FL3B). Participants can expect to be in the study for 4 years or until the study is closed or until they stop taking part.
The purpose of this study is to find out at which doses the investigational drug RO6958688 (study drug) can be administered safely to patients in combination with atezolizumab (study drug), and what the side effects are when both drugs are given together.
The study will be conducted in two parts.
Part I ? Patients will receive the study drug RO6958688 every week or every 3 weeks and atezolizumab every 3 weeks
Part II ? Patients will receive study drugs with the dose and schedule of RO6958688 determined in the Part I of the study and atezolizumab at 1200 mg every 3 weeks. Approximately 25 patients may be enrolled for this expansion part.
The investigator in charge of this study at MUSC is Dr. Michael Lilly. The study is being done at 26 sites in Europe and in the USA . Approximately 125 people will take part study-wide, and approximately 5 at MUSC.
MSC2363318A is an investigational drug that is being evaluated for the treatment of subjects with advanced malignancies. Investigational means that it has not been approved by the Food and Drug Administration (FDA), and is still being tested for safety and effectiveness. This study will be divided into 2 parts. MUSC will participate in Part 2. The investigational drug will be given as a monotherapy, in combination with Tamoxifen (an FDA approved drug) and will be given in combination with Trastuzumab (also an FDA approved drug). The study is sponsored by EMD Serono. The investigator in charge of this study is Dr. Sara Giordano. The study is being done at 12 sites nationally. Approximately 64 people will take part, and 5 will take part at MUSC. In order to be eligible, subjects must be older than 18, have advanced maliginancies and specific genetic mutations.
The duration of the study will depend on how the subjects cancer responds to the medication and how it is tolerated.