Trujillo

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating MK-5684, a study medicine that blocks the body from making steroid hormones, to treat certain solid tumors including breast, ovarian, and endometrial cancers. The goal is to find out if people receiving MK-5684 live longer without their cancer growing or spreading compared to those receiving standard treatments. This is a phase 2, open-label study involving participants with specific types of hormone receptor positive breast cancer, high-grade ovarian cancer, and low-grade endometrioid carcinoma. Participants will receive MK-5684 tablets orally as the investigational treatment. The study also includes standard care drugs such as fludrocortisone, dexamethasone, fulvestrant, exemestane, megestrol acetate, tamoxifen, and letrozole, delivered via tablets or injections as needed. The study is divided into cohorts based on cancer type and prior treatments, with participants receiving the appropriate therapies according to their cohort classification. During the study, participants will be monitored up to approximately two years for progression-free survival, which measures the length of time without cancer growth or spread. Researchers will assess participants' recovery from previous therapies, manage any side effects, and monitor HIV or hepatitis virus status if applicable. Various assessments including clinical evaluations and safety monitoring will be conducted throughout the participation period to evaluate treatment effects and participant health.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Gallstones are common in women and are a major risk factor for gallbladder cancer (GBC), a serious disease with limited treatment options. This research aims to improve how well we can predict the risk of GBC and detect it early by studying differences in geography, environment, lifestyle, ethnicity, gender, and molecular markers. The goal is to develop better prevention programs and improve understanding of how lifestyle and genetic factors contribute to GBC development. The study involves collecting epidemiological, clinical, and dietary information, along with samples of blood, saliva, urine, bile, feces, and gallbladder tissue. These samples will be used to identify and study new biomarkers for GBC, build a biorepository, develop a risk scoring system, and explore new treatment options. The study includes patients with gallbladder cancer or precancerous conditions and those with gallstones scheduled for gallbladder removal. Participants will provide various samples and data which researchers will use to measure the number of participants developing gallbladder cancer or dysplasia, either at the start or after examination of removed gallbladders. The project also supports training researchers and aims to help shape health policies. The study is observational and does not involve any experimental treatments, focusing instead on gathering data to improve prevention, diagnosis, and future treatments for GBC.

Researchers are evaluating a phase 3 study of pembrolizumab combined with carboplatin and a taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT) in adults with metastatic squamous non-small cell lung cancer. The study aims to determine if adding sac-TMT maintenance to pembrolizumab improves overall survival compared to pembrolizumab alone. Participants have confirmed stage IV squamous NSCLC and measurable disease. All participants first receive an induction phase of four cycles lasting 21 days each. During induction, they receive pembrolizumab every 3 weeks plus carboplatin every 3 weeks, along with either paclitaxel every 3 weeks or weekly nab-paclitaxel. After induction, participants are randomly assigned to continue pembrolizumab maintenance alone or pembrolizumab combined with sac-TMT maintenance. Treatments are given by intravenous infusion. Participants undergo scans to measure tumor response and are monitored for side effects and overall health. Researchers assess overall survival up to about 50 months. Organ function, adverse events, and performance status are regularly evaluated before and during the study. The study includes safety monitoring and follows participants through their treatment and maintenance phases.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.