A Phase 3 Randomized Active-controlled Open-label Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)
This is a Phase 3 study testing whether the study medicine MK-2870 is safer and more effective compared to the doctor's choice of other standard chemotherapy medication in patients with cervical cancer that has spread from the primary site (metastatic) or has come back after previous treatment (recurrent). MK-2870 is an antibody-drug conjugate that attacks and kills cancer cells more specifically than traditional chemotherapy. The study will be done in two parts. In Part 1, called Run-in, a small number of patients will be enrolled to test whether MK-2870 at a dose of 4 mg/kg is safe and effective in patients with metastatic cervical cancer. In Part 2, called Phase 3, a larger number of patients will be randomly divided into two groups. Group 1 will receive the study medication, MK-2870, at 4 mg/kg. Group 2 will receive the doctor’s chosen treatment, which will be one of the following: Pemetrexed, Tisotumab vedotin, Topotecan, Vinorelbine, Gemcitabine, or Irinotecan. All patients will have regular study visits throughout the study duration. Blood samples will be collected to check how patients are doing and learn how their bodies are handling the study medications. Specialized blood testing to monitor changes in DNA, RNA, and proteins (biomarkers) and ctDNA (circulating tumor DNA, which are small pieces of DNA shed by tumor cells in the blood) will be done to learn more about patients’ cancer and further help them with treatment. Special scans will be done for all patients to see how their tumors are changing in response to the study medication. All patients will be closely monitored for potential side effects and safety concerns.
A Phase 3 Randomized Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)
This is a Phase 3 study testing whether the study medicine sacituzumab tirumotecan ( sac-TMT, antibody-drug conjugate (ADC) targeting TROP2), given alone or with pembrolizumab (immunotherapy), can treat triple-negative breast cancer (TNBC) in patients whose tumor shows little to no PD-L1 expression (CPS
A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC Lenalidomide and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy.
This is a phase 3 study to test medicines named Teclistamab (Tec-DR) and Talquetamabin (Tal-DR) together with standard treatment called Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in patients who are newly diagnosed with blood cancer and are ineligible or not intended to get Stem Cell Transplant as the first treatment. Patients will be grouped to receive either Tec-DR, Tal-DR or DRd drugs. All patients will have blood samples taken to see how well patient's body is handling this treatment. Doctors will closely monitor patients who has received the study medicines for any side effects, to see if these medicines are safe and well tolerated, examine the results of blood work, do the vital sign measurements and physical examination. The patients will be followed up to 30 days (+7 days) after the last dose of study treatment or before the start of a new treatment, whichever comes first.
A Phase I Multicenter Open-label First-in Human Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Tumors
This is a first-in-human modular Phase 1, open-label, multi-center study to evaluate the safety and tolerability and identify a recommended phase 2 dose (RP2D) of AZD9592 alone and with a specific combination treatment, in EGFR and cMET expressing tumors, initially NSCLC EGFR mut (L858R/ex19del) and wild type, as well as HNSCC. The study will also evaluate the preliminary efficacy, PK, PD and immunogenicity of AZD9592.
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 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 RANDOMIZED PHASE 3 TRIAL OF CONTINUOUS VS. INTERMITTENT MAINTENANCE THERAPY WITH ZANUBRUTINIB AS UPFRONT TREATMENT IN OLDER PATIENTS WITH MANTLE CELL LYMPHOMA (INTERCON)
This is a Phase 3 study testing whether continuous or intermittent treatment with the study medicine Zanubrutinib (a kinase inhibitor) and rituximab (a monoclonal antibody) is a more effective treatment option for older patients with Mantle cell lymphoma. Once the patient is enrolled in the study, they will receive the study medicine Zanubrutinib and rituximab. Patients from this group whose cancer does not grow or spread will be randomly divided into two groups. Group A patients will continue the study medicine until their cancer comes back, or they have bad side effects from the study medicine. Group B patients will continue the study medicine until their cancer comes back (progression). Patients will restart the study medicine Zanubrutinib within less than 21 days after the confirmed progression of their cancer. Patients will continue to receive the study treatment until their cancer comes back for the second time (second progression) or unacceptable side effects. Special scans will be performed on all patients during the study to see whether the tumor size is changing. All patients will be closely monitored for side effects and safety concerns and will be followed up every 6 months for 10 years following registration.
An Adaptive Phase 2/3 Multicenter Double-Blind Placebo-Controlled Randomized Parallel 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient s Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis (EVOID-AS)
The primary objective of this study is to evaluate the efficacy of DA-1229 vs. placebo in reducing progression of aortic valve calcification in subjects with mild to moderate aortic stenosis.
An Open-label Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
This clinical study will evaluate MK-2870 either alone or in combination with pembrolizumab versus TPC in participants with HR+/HER2- (both HER2-zero and HER2-low) unresectable locally advanced or MBC, who have not been previously treatedwith chemotherapy in the metastatic setting.
Cellular Viscosity as a Marker for Alzheimer s Disease Pathology: A Combined Multiparametric MR Spectroscopy and PET Study
This project proposes the use of Magnetic Resonance Spectroscopic Fingerprinting (MRSF) to quantify changes in intracellular viscosity separately within neurons and astrocytes and assess AD pathophysiology. We will work with the NYU AD Research Center to include our MRSF sequence within their routine tau-PET/MRI protocol, allowing for serial follow-up of a cohort of 100 cognitively normal individuals and patients with mild cognitive impairment. Both sets of subjects will undergo yearly neurocognitive assessments, plasma Aß and plasma tau evaluations; and biennial Aß-PET, tau-PET, and MRI+MRSF scans. The expected outcome of this work is a set of novel markers for neuronal and astrocytic intracellular viscosity which will potentially become biomarkers for early prediction of neurodegeneration and cognitive decline in AD, addressing gaps in the current imaging armamentarium of the AT(N) network.