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Researchers are evaluating the safety and effectiveness of the PerQdisc Nucleus Replacement Device NRD for patients with degenerative disc disease DDD causing chronic low back pain. This prospective, open-label, multi-center study involves 72 patients who have DDD in one or more lumbar discs between L1 and S1. The study aims to collect additional data on this minimally invasive device, which is designed to maintain disc height and preserve spinal motion compared to the current standard spinal fusion surgery. Participants will undergo nucleus replacement surgery using the PerQdisc device via standard anterior, lateral, or minimally invasive posterolateral surgical approaches to replace the single nucleus pulposus in the affected lumbar disc. All surgeries require approval from a Medical Advisory Board. The study focuses on patients who have exhausted at least six months of conservative treatments for their back pain and meet specific criteria, including disc height and pain scores. During the study, participants will be monitored closely with evaluations at multiple time points up to five years. Researchers will assess performance outcomes such as disability Oswestry Disability Index, pain levels Visual Analog Scale, disc height, and range of motion, as well as safety outcomes including device expulsion, failure, neurological status, revision surgeries, and serious adverse events. Follow-up visits will include questionnaires, imaging, and clinical assessments to track the devices impact over time.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

This research is an extension study for participants with cancer who have been previously enrolled in a Genentech andor F. Hoffmann-La Roche sponsored study. It aims to provide continued treatment with Roche investigational medicinal products IMPs either as monotherapy or combined with other agents for those still on study treatment at the time of rollover, particularly when local access to the study treatment is not available. The study is open-label and multicenter, focusing on long-term treatment continuation under medical supervision. Participants will continue receiving Roche IMPs following the same dose, schedule, and administration guidelines as in the parent study. Treatments include monotherapy or combination therapy with drugs such as Ipatasertib, Tiragolumab, Atezolizumab, Bevacizumab, Entrectinib, Inavolisib, and Divarasib. Treatment continues until disease progression, loss of clinical benefit, death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, local treatment availability, or study termination. During the study, participants are monitored for ongoing treatment benefits and adverse events as assessed by standard criteria. Researchers measure the number of participants maintaining access to Roche IMP-based therapy and track the number and severity of selected adverse events over up to approximately 10 years. Safety and treatment effectiveness are evaluated regularly, with participant follow-up continuing as long as treatment is administered or until study completion.

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 the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are evaluating sacituzumab tirumotecan alone and in combination with pembrolizumab compared to treatment chosen by the physician in participants with hormone receptor positivehuman epidermal growth factor receptor-2 negative HRHER2- breast cancer that is locally advanced, unresectable, or metastatic. The study aims to see if these treatments improve progression-free survival compared to standard physician-chosen therapies. This is a Phase 3 clinical trial assessing advanced breast cancer treatments. Participants are randomly assigned to one of three groups sacituzumab tirumotecan alone given by intravenous infusion every two weeks until disease progression or discontinuation sacituzumab tirumotecan plus pembrolizumab with sacituzumab tirumotecan given every two weeks and pembrolizumab given every six weeks for up to about two years or treatment chosen by the physician, which may include various chemotherapy options such as paclitaxel, nab-paclitaxel, capecitabine, or liposomal doxorubicin, administered with schedules depending on the drug. Treatments continue until disease progression or discontinuation. During the study, participants will have regular assessments including imaging to evaluate progression-free survival, overall survival, response rates, and quality of life measures using questionnaires. Safety is monitored by tracking adverse events and treatment discontinuations. The primary outcome is measured up to approximately 38 months, with additional secondary outcomes followed up to about 77 months. Participants are followed closely through study visits and evaluations throughout the trial period.

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement TAVR using the Sapien 3 valve. This international, multi-center study aims to determine if the algorithm improves technical success immediately after the procedure and device success 30 days later. The study also examines how additional imaging techniques like gated computed tomography and artificial intelligence-based simulations influence treatment decisions. The study involves about 290 patients eligible for TAVR or surgical aortic valve replacement SAVR. Physicians use the ABC Bicuspid Sizing Algorithm to guide treatment allocation between TAVR and SAVR, as well as valve sizing and deployment for those receiving TAVR. Some patients may have further evaluation with gated CT or AI simulations to assess risks. Data for TAVR patients is collected at baseline, during the procedure, at hospital discharge, 30 days after, and annually up to 5 years. SAVR patients have data collected at baseline and during the procedure only. Participants will undergo diagnostic imaging including CT scans evaluated with the sizing algorithm and may receive additional assessments if indicated. Researchers collect data on procedure success, device outcomes, conduction disturbances, pacemaker implants, stroke, vascular complications, mortality, valve function, and hospitalizations for heart failure over 5 years. Follow-up visits occur at 30 days and annually, allowing long-term monitoring of outcomes after treatment.

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin ZV combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma rrDLBCL. This Phase 23 study is divided into two parts Dose Confirmation and Efficacy Expansion. It aims to compare ZV combined with rituximab, gemcitabine, and oxaliplatin R-GemOx against R-GemOx alone, and ZV combined with bendamustine rituximab BR against BR alone, focusing on progression-free survival. Enrollment in the BR-related arms has been discontinued with no analysis planned for those arms.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating a canaloplasty device for people with open-angle glaucoma undergoing cataract surgery. The study aims to assess the safety and effectiveness of this device in managing eye pressure in this condition. This first-in-human trial is conducted by New World Medical, Inc. and is designed to provide important information about this surgical system. Participants will be treated with a US FDA-approved canaloplasty device during their cataract surgery. The study focuses on how the device affects intraocular pressure IOP and the need for IOP-lowering medications over time. There is one treatment group involving the use of this canaloplasty and trabeculotomy surgical system. During the study, participants will have their intraocular pressure measured, with the main outcome being the change in IOP one year after surgery. Researchers will also monitor IOP levels and medication use at 12 months. The study begins in September 2025 and continues through October 2027, involving regular follow-up visits to track safety and effectiveness results.