A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
This is a study that looks at whether it's safe to treat patients with bladder cancer who have certain gene changes (called DDR gene alterations) in their tumor. These patients have had a procedurecalled TURBT (a way to remove part of the tumor) before treatment. They will get chemotherapy with gemcitabine and cisplatin. The study will check if the treatment works well by looking at how many patients are still cancer-free three years after they start treatment. If more than 80% of the patients are cancer-free at that time, the treatment will be considered safe. The patients will also be watched for five years to see how many stay cancer-free. If patients' tumors do not have these gene changes, or if the tumor shrinks but not enough, they will have their bladder removed (called cystectomy) and will be followed for five years to see if the cancercomes back or if they survive longer. If patients who could have had bladder-preserving treatment end up having their bladder removed, they will also be watched for five years to see how they do.
A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer (EBC). Secondary Objectives:To estimate distant metastasis-free survivalTo estimate overall survival (OS).To evaluate safety and tolerabilityTo identify predictors of loco-regional recurrence.
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 EVALUATING THE SAFETY AND EFFICACY OF MR-LINAC- GUIDED RADIOTHERAPY AS SALVAGE TREATMENT AFTER EXTERNAL BEAM RADIOTHERAPY RECURRENCE (TUMORNATOR II)
This Phase 2 study is testing how using a special imaging technique called the Elekta Unity MR-linac system can be safe and effective for patients with prostate cancer that has not spread to other parts of the body after previous treatment with radiotherapy. Patients will have special scans taken before the study treatment to help the study team determine the treatment planning and doses. All patients will then be treated using an MR-guided approach on the Elekta Unity MR-linac system. The study team will collect tissue samples from all patients after treatment to see how the treatment is changing the tumor. All patients will have special scans taken and the study doctor will examine them to see how the patients are doing. All patients will be closely monitored for side effects and safety and followed every 6 months for up to 2 years after their treatment.
A Phase II/III Multicenter Randomized Double-Blind Placebo-Controlled Two-Part Adaptive Design Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer s Disease
Remternetug is an investigational drug, currently being studied to treat Alzheimer's Disease (AD).The purpose of this study is to determine if remternetug has favorable effects that may prevent or reduce the AD disease in the brain and prevent or delay AD symptoms, participants will have brain scans, blood and spinal fluid collected (for biomarkers, the tests that indicate progress of disease and response to study treatment), and tests of memory and thinking. This study will consist of 2 stages, which could last up to 9 years and will involve about 50 visits (30 visits in Stage 1, 20 visits in Stage 2).
A phase II/III Study of Paclitaxel/Carboplatin alone or Combined with either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-zzfx (PHESGO) in HER2 Positive Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
This study is being done to answer the following question: Can we lower the chance of your endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs?
A Phase III Multi-center Open-label Sponsor-blinded Randomized Study of AZD0901 Monotherapy Compared with Investigator s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
This study is designed to test how effective a new treatment called AZD0901 is for patients with advanced stomach cancer or cancer that is at the junction of the stomach and esophagus (GEJ) that shows a specific marker called CLDN18.2. In this study, patients will be divided into three groups. One group will receive AZD0901 and the other group will get a treatment chosen by their doctor from a list of commonly used cancer therapies. Patients will continue with their treatment until it is no longer effective or safe for them.
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.