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Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.

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 studying a trial medicine called MK-7262 to lower the level of Lipoproteina or Lpa in the blood. This trial also looks at another medicine named enlicitide, which lowers low-density lipoprotein cholesterol LDL-C. The study aims to find out if taking MK-7262 alone or together with enlicitide works better than a placebo in lowering Lpa and LDL-C levels. The safety and tolerability of these medicines are also being evaluated. Participants will be randomly assigned to one of four groups. One group will take both MK-7262 and enlicitide placebos, the second will take enlicitide with an MK-7262 placebo, the third will take MK-7262 with an enlicitide placebo, and the fourth will take both MK-7262 and enlicitide. All treatments are oral tablets taken once daily for about 12 weeks. During the study, participants will have their Lpa and LDL-C levels measured at baseline and at weeks 8 and 12 to assess changes. Researchers will monitor any adverse events and whether participants stop treatment due to side effects, with safety observed for up to approximately 20 weeks. The study also tracks other related outcomes like percentages of participants reaching specific Lpa levels. Overall participation lasts up to about 12 weeks of treatment plus follow-up.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.

Researchers are evaluating the efficacy and safety of the experimental drug ACR-368 alone or combined with ultra-low dose gemcitabine ULDG sensitization in participants with high-grade endometrial cancer. This Phase 2 open-label study divides participants into groups based on a test called OncoSignature, which predicts tumor sensitivity to ACR-368. Some groups receive ACR-368 alone while others receive it with ULDG, and treatment continues until disease progresses or unacceptable side effects occur. Participants are assigned to four different arms Arm 1 includes OncoSignature Positive tumors treated with ACR-368 alone Arm 2 includes OncoSignature Negative tumors treated with ACR-368 plus ULDG sensitization Arm 3 and Arm 4 include participants without OncoSignature selection, receiving either ACR-368 with ULDG or ACR-368 alone, respectively. Participants in the European Union are only enrolled in the unselected groups Arms 3 and 4. Treatment is administered continuously until progression, toxicity, or withdrawal. During the study, participants undergo tumor assessments every 8 weeks for up to two years or until death to measure anti-tumor activity. Safety is monitored by recording adverse events and pharmacokinetic testing occurs at specific times during the first treatment cycle. Other outcomes include overall survival, duration of response, and progression-free survival. Participants provide tumor tissue samples either from new biopsies or archival tissue depending on their assigned arm. The study runs from screening through treatment and follow-up until study completion in November 2027.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

Researchers are evaluating the safety and immune response of a second dose of the RSVpreF vaccine in pregnant women during later pregnancies. The study also aims to understand how long the protection lasts from a single dose given during a previous pregnancy by examining blood samples from nonpregnant participants who had the vaccine before. This Phase 3 trial involves pregnant participants and their unborn babies, as well as nonpregnant participants previously vaccinated. Pregnant participants are divided into two groups one group who previously received RSVpreF in a Pfizer trial will get a second dose, and another group will be randomly assigned to receive either RSVpreF or a placebo if no prior antibody data exists. Infants born to these participants will be followed for six months to monitor safety and antibody levels. Nonpregnant participants who received RSVpreF in an earlier trial will provide blood samples to assess the durability of their immune response without receiving additional vaccine doses. Participants will undergo safety monitoring including tracking local and systemic reactions, adverse events, and serious events during pregnancy and after birth for infants. Blood tests will measure neutralizing antibodies against RSV types A and B at birth, 3 months, and 6 months. The study includes consent procedures for both pregnant participants and infants, and nonpregnant participants will have scheduled visits for blood sample collection. The total study duration extends through infant follow-up and ongoing immune response assessments.

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for 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 and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-L1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.