A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination with Ipilimumab Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination with Ipilimumab, Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
A phase II trial of ImmunotheRapy with single fRactIon non-ablative raDIAtion in previously untreated patients with stage IV NSCLC. (IRRIDIATE-Lung trial)
This is a phase II open label trial of pembrolizumab sequentially following upfront non-ablative focal therapy to up to five distinct metastatic subsites in de novo stage IV Non-Small Cell Lung Cancer (NSCLC). The primary goal of this trial is to evaluate the efficacy of upfront non-ablative focal radiation (RT) to index lesions as a way of enhancing the anti-tumor immune response to pembrolizumab.
A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma Grade IIIb Follicular Lymphoma transformed lymphoma and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements
A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma, Grade IIIb Follicular Lymphoma, transformed lymphoma, and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements
A Phase IIa Open-label Clinical Trial to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination with Venetoclax plus Decitabine in Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Induction Therapy
A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination with Venetoclax plus Decitabine in Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Induction Therapy
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY SAFETY PHARMACOKINETICS AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI-N-METHYL-D-ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI-LEUCINE-RICH GLIOMA-INACTIVATED 1 (LGI1) ENCEPHALITIS
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid receptor (NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis.Current treatment of these disorders exclusively use off-label immune therapies and is based on expert opinion, retrospective case series, and open-label studies. Several unmet needs exist, including the frequent occurrence of long-term cognitive deficits, insufficient seizure control, frequent dependence on high-dose corticosteroids, and faster-acting but durable immunotherapy. There is a need for prospectively generated evidence-based treatments to meaningfully lessen the acute and long-term consequences of these disorders.
A Phase III Randomized Double-Blind Placebo-Controlled Multicenter Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS
This is a parallel-group, double-blind, randomized, placebo-controlled study comparingthe efficacy and safety of obinutuzumab versus placebo among patients with ISN/RPS2003 Class III or IV LN treated with standard-of-care therapy with MMF andcorticosteroids. The study will enroll approximately 252 patients.Patients must be 18?75 years of age and have ISN/RPS Class III or IV proliferative LNas evidenced by renal biopsy performed in the 6 months prior to screening or duringscreening. Patients may have concomitant Class V disease (i.e., Class III/V orClass IV/V). Patients must exhibit significant proteinuria as evidenced by a UPCR ? 1based on a 24-hour urine collection during screening.Key exclusion criteria include evidence of severe renal impairment, defined by an eGFR? 30 mL/min per 1.73 m2 of body surface area or ESRD requiring dialysis ortransplantation; evidence of active infection; and other safety-related exclusions.The study consists of the following study periods: screening, blinded treatment,open-label treatment (OLT), and study follow-up.
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY SAFETY PHARMACOKINETICS AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)
This Phase III, randomized, double-blind (DB), placebo-controlled, multicenter study isdesigned to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics ofsatralizumab compared with placebo as monotherapy or in addition (add-on) tobaseline/background ISTs for MOGAD relapse prevention.The study will include a screening period of up to 28 days, an event-driven DB treatment period, and an approximately 2-year open-label extension (OLE) period.
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY EVALUATING ATEZOLIZUMAB AND BEVACIZUMAB WITH AND WITHOUT TIRAGOLUMAB IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
A pilot neuroimaging study of adults with prolonged grief disorder (PGD) compared to bereaved controls after death of a spouse or parent
For this study we will recruit an estimated 20 participants to have 10 participants be eligible and complete the study. They will be adults age 40 to 65 who have experienced spousal or parental loss in the last one to three years prior to baseline intake. Half the participants will meet criteria for prolonged grief disorder (PGD) for whom grief is the primary current emotional concern, while the control group will be bereaved adults without PGD. After completing initial screening procedures, consenting, and clinical eligibility assessments including structured clinical interviews for DSM5 diagnoses and PGD with a study clinician, subjects will complete additional clinical assessments and a battery of validated experimental tasks with psychophysiology in an fMRI scanner.