Torquay

Researchers are evaluating two different pacing methods for patients with slow heart rates in this multi-center trial. The study compares the standard right ventricular pacing with a newer physiological pacing approach, which includes His bundle pacing or left bundle pacing. This trial aims to better understand the effects of these pacing methods on heart function and patient outcomes over time, including a sub-study focused on heart muscle changes related to pacing. Participants will receive a pacemaker implanted at a participating center and be randomly assigned to either right ventricular pacing or physiological pacing. For physiological pacing, if His or left bundle pacing is not successful, biventricular pacing will be used instead. The trial includes an optional echocardiographic sub-study for some patients to assess heart changes over 24 months. Participants will be followed for up to 78 months, with assessments at baseline and every six months. Researchers will measure outcomes such as survival, heart failure events, quality of life questionnaires, symptoms, device-related safety events, and heart rhythm data collected from the pacemakers. The sub-study will use echocardiograms to evaluate changes in heart volume and pumping efficiency. This comprehensive follow-up aims to capture both clinical effects and mechanistic insights of the pacing methods.

Researchers are evaluating a new medicine called ifinatamab deruxtecan I-DXd for treating men with metastatic castration-resistant prostate cancer mCRPC. The study aims to find out if people receiving I-DXd live longer overall and have longer periods without cancer growth or spread compared to those receiving chemotherapy. This is a Phase 3, open-label trial sponsored by Merck Sharp Dohme LLC. Participants in the study will be randomly assigned to receive either I-DXd at a dose of 12 mgkg every 3 weeks or a combination of docetaxel chemotherapy 75 mgm every 3 weeks with daily prednisone. I-DXd is given by intravenous infusion every 3 weeks until the disease progresses or side effects prevent continued treatment. Premedication is given before I-DXd to help prevent nausea and vomiting. During the study, participants will be closely monitored for overall survival and radiographic progression-free survival for up to about 36 months. Researchers will also assess several other outcomes including response rates, time to progression, pain progression, prostate-specific antigen changes, and side effects. Safety and treatment tolerability will be tracked throughout, and participants health will be regularly evaluated with scans and other tests.

Researchers are evaluating new treatment options for people with high-risk non-muscle invasive bladder cancer HR NMIBC, a type of bladder cancer that affects the inner lining of the bladder but has not spread to the muscle or beyond. This includes carcinoma in situ CIS, a flat form of bladder cancer limited to the bladders surface. The study aims to find out if adding intismeran autogene, an immune system-targeting treatment, to the standard Bacillus Calmette-Guerin BCG therapy can improve outcomes for people with HR NMIBC by helping the immune system attack the cancer more effectively. Participants are assigned to different groups. One group receives both intismeran autogene by intramuscular injection every three weeks for nine doses along with BCG treatment given once weekly for six weeks, followed by additional weekly doses at later weeks. Another group receives BCG alone on the same schedule, while a third group receives only intismeran autogene. The study compares these treatments to see if the combination improves survival without cancer growth, spread, or return. During the study, participants will be monitored for up to approximately five years to track event-free survival, recurrence-free survival, overall survival, and other outcomes. Researchers will also evaluate adverse events and treatment tolerability. Follow-up includes assessments at regular intervals to observe disease status and safety. The total participation time may last several years to gather long-term data on treatment effects.

Researchers are evaluating the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC that tests positive for human papillomavirus 16 HPV16 and expresses the protein PD-L1. This Phase IIIII trial includes patients whose tumors have a combined positive score of 1 or higher for PD-L1. The study is designed to generate important safety and efficacy data for these treatments in this patient group. The trial consists of two parts Part A is a non-randomized safety run-in phase to confirm the safety and tolerability of BNT113 with pembrolizumab. Part B is a randomized phase comparing BNT113 combined with pembrolizumab versus pembrolizumab alone. Treatments are given by intravenous injection or infusion. Patients may receive treatment for up to 24 months. An optional pre-screening phase allows tumor samples to be tested centrally for HPV16 DNA and PD-L1 expression before entering the main trial. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events, overall survival, and progression-free survival for up to 48 months. Researchers will also measure response rates and duration, disease control, and any dose adjustments due to side effects. Patients provide tumor tissue samples before treatment and are monitored closely throughout the study period. The trial aims to collect comprehensive data on safety, treatment effects, and patient outcomes over this extended follow-up.

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer mNSCLC whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1 or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy carboplatin or cisplatin and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are studying patients with cirrhosis caused by alcohol-related or metabolic dysfunction-associated steatotic liver disease MASLD. The trial aims to evaluate whether taking capsules containing faecal microbiota from healthy donors can reduce infections and mortality in these patients. This Phase 3 trial follows earlier research that showed faecal microbiota transplantation FMT delivered via endoscopy was safe and feasible, leading to the development of capsules for easier treatment administration. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical but contain no active treatment. They will take five capsules every three months over a total period of 21 months or until they develop an infection requiring hospital admission. This double-blind trial means neither participants nor study staff will know which treatment is given. The study will last up to 24 months including follow-up, monitoring effects on infection rates, liver health, immune system function, and antibiotic resistance. Throughout the trial, participants will be regularly assessed for infections, liver disease progression, hospital admissions, quality of life, mental health, alcohol use, and safety of FMT treatment. Laboratory tests will examine immune response and bacterial resistance. The primary outcome is the time until first infection needing hospital care. The study involves detailed monitoring and follow-up visits for up to two years to understand the treatments impact and safety in patients with cirrhosis.

Researchers are studying two combination treatments as front-line therapies for adults with stage IV or advanced stage IIIBC nonsquamous non-small cell lung cancer NSCLC that carries a KRAS p.G12C mutation and is negative for PD-L1. This phase 3 trial compares progression-free survival and overall survival in participants receiving either sotorasib with platinum doublet chemotherapy or pembrolizumab with platinum doublet chemotherapy. The goal is to evaluate which treatment combination may better manage this specific lung cancer type. Participants receive one of two treatment combinations sotorasib taken orally with carboplatin and pemetrexed, or pembrolizumab given intravenously with carboplatin and pemetrexed. These therapies are administered as front-line treatments. The study is randomized and open-label, meaning participants are assigned to a treatment group by chance and both participants and researchers know which treatment is given. During the study, participants will be monitored regularly for disease progression and survival over approximately 2.5 years. Additional assessments include quality-of-life questionnaires focusing on symptoms like dyspnea, cough, and chest pain, as well as physical function and global health status up to week 12. Safety is evaluated by tracking adverse events, vital signs, and laboratory test changes throughout the study, which may last up to about 5.5 years including follow-up. Participants receive care under medical supervision while contributing to important research on lung cancer treatment.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 bcg on heart and lung outcomes in people with chronic obstructive pulmonary disease COPD who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate GFF MDI 14.49.6 bcg. The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating the antitumor activity of amivantamab combined with lazertinib or with chemotherapy in participants who have common EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC. This Phase 2b open-label study aims to understand how well these combinations work as first-line or second-line treatments for this type of lung cancer. Participants will be assigned to one of two groups one group will receive amivantamab combined with lazertinib orally in 28-day cycles, and the other group will receive amivantamab combined with platinum-based chemotherapy carboplatin and pemetrexed given by intravenous infusion in 21-day cycles. Treatment will continue until disease progression, withdrawal, death, or investigator decision to stop treatment. During the study, participants will undergo regular assessments including monitoring for progression-free survival up to 4 years and 6 months. Additional evaluations include tracking dose changes, adverse events, overall survival, response rates, and time to treatment discontinuation. Safety and clinical outcomes will be closely observed throughout the treatment period and follow-up.

Researchers are evaluating the anti-tumor activity and safety of amivantamab given as a subcutaneous co-formulation with recombinant human hyaluronidase PH20 rHuPH20 in participants with advanced or metastatic non-small cell lung cancer NSCLC, including those with specific EGFR mutations. This Phase 2, open-label study includes multiple cohorts with different treatment histories and EGFR mutation types to better understand how amivantamab works in combination with other therapies and to assess its safety profile. Participants receive amivantamab subcutaneously at varying doses based on body weight and specific treatment cohorts. Some cohorts combine amivantamab with oral lazertinib or intravenous chemotherapy drugs such as carboplatin and pemetrexed, administered on different schedules ranging from every two to three weeks in 21- or 28-day cycles. Additional treatments like prophylactic anticoagulation may also be given in certain cohorts. Participants may have the option to enter a long-term extension phase to continue receiving study treatments. During the study, participants undergo regular evaluations including tumor assessments based on RECIST criteria and safety monitoring through adverse event tracking and laboratory tests. Researchers will measure objective response rates and other outcomes up to 1 year and 6 months, and for some cohorts, safety will be monitored for up to nearly 5 years. Participants quality of life and treatment satisfaction are also assessed. The total duration of participation varies according to cohort and treatment response, with follow-up continuing after treatment completion.