Edgewood

Researchers are investigating new treatments for extensive-stage small cell lung cancer ES-SCLC, a type of lung cancer that has spread widely within the lungs or to other parts of the body. This study evaluates the combination of two study medicines, gocatamig and I-DXd ifinatamab deruxtecan, with or without standard chemotherapy and immunotherapy. The research aims to understand the safety and tolerance of these combinations and whether they can shrink or eliminate tumors in people with ES-SCLC. Participants are assigned to one of several treatment groups. Some receive gocatamig and I-DXd during maintenance after completing standard chemotherapy and immunotherapy, while others receive these study medicines during both induction and maintenance phases. Additional groups receive gocatamig and I-DXd followed by gocatamig and atezolizumab, or standard treatment with carboplatin, etoposide, and atezolizumab followed by atezolizumab maintenance. Treatments are given intravenously and continue until disease progression or other study-specified criteria. During the study, participants will have regular assessments to monitor safety, side effects, and treatment response, including scans to measure tumor size and laboratory tests to evaluate drug levels and immune response. The study will track adverse events, treatment tolerability, and cancer control over up to approximately 58 months. Participants health status and responses to the treatments will be closely observed throughout this period, with periodic evaluations to understand long-term effects and outcomes.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Researchers are evaluating LNCB74, an antibody drug conjugate, in participants with advanced solid tumors including ovarian, breast, endometrial, biliary tract, and non-small cell lung cancers. This phase 1, open-label study aims to determine the safety, tolerability, and the recommended dose for future studies by escalating doses and expanding treatment in selected tumor types. The study is sponsored by NextCure, Inc. and focuses on participants with measurable disease and adequate organ function. Participants will receive LNCB74 intravenously every 21 days in two parts Part 1 involves dose escalation to find the maximum tolerated dose or recommended phase 2 dose, with additional safety and biomarker assessments. Part 2 involves dose expansion and optimization to further evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics in a more uniform group of participants. Treatment continues unless unacceptable side effects or clear disease progression occur. During the study, participants will undergo regular safety and response evaluations including tumor assessments, biomarker analysis, and pharmacokinetic measurements. Key outcomes include safety, tolerability, response rates, and progression-free survival over up to 24 months. Blood samples will be taken to study drug levels and immune response. Participants are monitored closely for adverse effects and effectiveness, with a minimum life expectancy of 12 weeks required to join.

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.

Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

Researchers are evaluating nemtabrutinib compared with investigators choice of ibrutinib or acalabrutinib in adults with untreated chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study aims to assess whether nemtabrutinib is not worse than these comparators in terms of objective response rate and whether it can provide longer progression-free survival. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will receive either nemtabrutinib, ibrutinib, or acalabrutinib orally at specified doses until their disease progresses, unacceptable side effects occur, or other discontinuation criteria are met. The trial uses a parallel-group design where participants are randomly assigned to one of the treatment groups, and no masking is involved. Both treatment arms continue until progression or intolerance. During the study, participants will be monitored regularly up to about 33 months for response rate and up to about 104 months for progression-free survival and overall survival. Assessments include clinical evaluations, safety monitoring for adverse events, and duration of response measurements. The study tracks treatment tolerability, discontinuations due to adverse events, and overall outcomes to better understand the therapies effects in this patient population.

Researchers are evaluating whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens in men with metastatic castration-resistant prostate cancer mCRPC, a type of prostate cancer that continues to grow despite low hormone levels. This Phase 3 study compares pasritamig plus docetaxel against docetaxel alone to see if the combination improves radiographic progression-free survival rPFS, which is the time until disease progression or death as seen on scans. Participants are randomly assigned to receive either pasritamig together with docetaxel or docetaxel plus prednisoneprednisolone as background medication. Treatment continues until disease progression is confirmed by scans or other criteria are met. The study is open-label, meaning both participants and researchers know which treatment is given. During the trial, participants will have regular scans such as CT, MRI, or bone scans to monitor disease progression, assessed by independent review. Researchers will also evaluate overall survival, symptom progression, response rates, prostate-specific antigen PSA levels, quality of life measures, and safety by tracking adverse events and lab results. The study may last up to approximately 4 years and 5 months, with frequent assessments throughout.