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Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are evaluating the effectiveness and safety of ACR-368 alone or combined with ultra-low dose gemcitabine (ULDG) sensitization in people with endometrial cancer. This is an open-label Phase 2 study involving participants with high-grade endometrial adenocarcinoma. Participants are grouped based on a test called OncoSignature, which predicts sensitivity to ACR-368, or by tumor subtype without requiring the test. Participants in Arm 1 and Arm 4 receive ACR-368 as a single treatment, while those in Arms 2 and 3 receive ACR-368 combined with ULDG sensitization. Arms 1 and 2 are for participants selected by OncoSignature status, while Arms 3 and 4 include participants with serous carcinoma regardless of OncoSignature results. Treatment continues until the disease progresses, unacceptable side effects occur, or the participant withdraws. Participants will have tumor response assessed every 8 weeks from the start of treatment through two years or until death. To join, participants must have measurable metastatic cancer that progressed after prior therapies, provide tumor tissue samples, and meet health and organ function requirements. Safety and response will be closely monitored throughout the study.

Researchers are evaluating the safety, tolerability, and immune response duration of a second dose of the RSVpreF vaccine given during later pregnancies. The study also examines how long immunity lasts from a single dose given during a previous pregnancy by analyzing blood samples from nonpregnant participants who had the vaccine before. This is a Phase 3 trial focused on pregnant women and their babies as well as nonpregnant women previously vaccinated. Pregnant participants are grouped into Cohort 1, who previously received RSVpreF in a Pfizer trial and will get a second dose, and Cohort 2, who received RSVpreF previously via commercial or trial means and will be randomly given either RSVpreF or placebo. Both groups will be monitored for safety and immune response. Cohort 3 includes nonpregnant women who had RSVpreF before and will provide blood samples to check how long protection lasts, without receiving further vaccination. Participants will undergo safety monitoring during pregnancy and after birth. Infants will be followed for six months to assess safety and antibody levels. Blood tests will measure immune response, including neutralizing antibodies at birth. The study tracks local and systemic reactions, adverse events, serious adverse events, and new medical conditions in both pregnant participants and their infants over various timeframes throughout the study.

Researchers are conducting a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab with investigator's choice monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who have incurable metastatic or recurrent disease. This study focuses on patients with progressive disease after anti-PD-1 therapy and platinum-containing therapy and aims to evaluate the treatments as second- or third-line options. Participants will receive either petosemtamab or one of the investigator's choice monotherapies, including cetuximab, methotrexate, or docetaxel. The study involves treatment administration under controlled conditions with monitoring for efficacy and safety. The goal is to assess the treatments over time with a focus on response rates and overall survival. During the study, participants will undergo regular assessments including radiologic imaging to measure tumor response, and evaluations of overall survival up to approximately three years. The primary outcomes include objective response rate assessed by blinded independent central review and overall survival. Researchers will monitor patient health, side effects, and treatment effectiveness throughout the study duration.

Researchers are evaluating the safety and effectiveness of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as a first treatment for people with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease, though prior therapy for locally advanced disease is allowed under certain conditions. The study excludes patients who have been treated with anti PD-(L)1 or anti-EGFR therapies except in specific cases. Participants will receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone as their first-line treatment for this condition. The study includes detailed eligibility criteria based on tumor location, PD-L1 expression, health status, and prior treatments. Treatment effects will be observed over time with a focus on overall survival and tumor response rates measured according to standard criteria. During the study, participants will undergo assessments including tumor biopsies, imaging scans to measure disease progression, heart function tests, and evaluations of organ function. Safety and treatment response will be closely monitored up to approximately three years. The study also tracks overall survival and tumor response rate as primary outcomes, ensuring continuous follow-up and support throughout the trial period.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating the effectiveness of pemigatinib in adults with advanced or metastatic pancreatic cancer that has spread to nearby tissues, lymph nodes, or distant body parts, and that have specific genetic changes in the FGFR gene. The study focuses on patients whose cancer has FGFR2 gene fusions or other FGFR alterations, aiming to see if pemigatinib can block these abnormal gene functions to stop tumor growth and possibly improve quality of life. This is a phase II trial conducted nationwide using a fully decentralized telemedicine approach to reach participants. Participants receive pemigatinib as an oral medication once daily for 14 days within each 21-day cycle. Treatment continues unless the disease progresses or unacceptable side effects occur. Alongside the drug treatment, patients undergo various imaging tests including CT scans, MRI, optical coherence tomography (OCT), and when needed, whole body bone scans and dilated eye exams (ophthalmoscopy). After finishing treatment, patients are followed up at 30 days and then every four months for one year to monitor their condition. Throughout the study, patients provide blood samples and undergo scans to evaluate treatment response and detect resistance mutations. Researchers track the overall response rate for up to 24 months and assess safety and tolerability. Patients must comply with scheduled visits, tests, and oral medication intake. The total study participation includes treatment cycles and a follow-up period lasting up to approximately 16 months after treatment completion.