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Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

This research aims to evaluate how well Virtual Reality VR can reduce pain and anxiety during painful procedures in patients with blood cancers, such as hematological malignancies. The study focuses on procedures like Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, and chemotherapy. Previous research suggests VR may help distract patients from pain and improve their overall experience during medical care. The trial uses a crossover design where each patient experiences two periods one with standard care and one with the addition of a VR session during the same procedure. There is also an external control group receiving only standard care, matched by age and procedure type for comparison. The VR intervention involves a headset connected to a smartphone that displays immersive visual and audio content tailored to the study population. Each VR session lasts as long as the painful procedure. Participants will undergo assessments of pain levels using a Numeric Rating Scale just before and after procedures. Anxiety will be measured with a standardized inventory before and after procedures as well. The study includes a washout period of at least seven days between the two treatment periods. Researchers will monitor how pain and anxiety change with and without VR distraction. The overall participation time varies depending on the procedures and scheduling.

Researchers are evaluating ABO-101 to study its safety, tolerability, how the body processes it, and its effects in people with primary hyperoxaluria type 1 PH1, a rare genetic condition. This Phase 12 clinical trial aims to find a recommended dose for adults and then assess this dose in children. The study is sponsored by Arbor Biotechnologies and includes a long-term follow-up to meet regulatory requirements. The trial has two main study periods. In the first period, Part A involves adults receiving single increasing doses of ABO-101 through an intravenous infusion to identify a suitable dose. Part B then treats pediatric participants with the chosen dose. After these parts, the second study period begins, focusing on long-term monitoring for safety and treatment effects. Participants will have regular assessments including monitoring for any treatment-related side effects over six months, measuring changes in urine oxalate and plasma glycolate levels, and tracking kidney function for up to two years. Blood and urine samples will be collected to study drug components and immune responses. The trial involves careful safety follow-up and ongoing evaluation throughout the study duration.

Heart failure is a common and serious condition that leads to many hospital visits and deaths worldwide. Access to specialized heart failure clinics is limited, although such care can improve patient outcomes. This international, multicenter randomized controlled trial called VICTORY-HF is studying whether adding a virtual heart failure clinic to routine care can improve medication use and health outcomes for patients recently discharged after hospitalization or urgent care for heart failure. Participants will be randomly assigned to receive either 90 days of virtual heart failure clinic care plus routine care or routine care alone. The virtual clinic offers structured remote follow-up, monitoring of physiological measures, and optimization of guideline-directed medical therapies. The trial will evaluate the effects of this intervention on medication use, patient-reported health status, mortality, hospital readmissions, and emergency visits. Participants will be followed for 90 days during the virtual clinic intervention, with co-primary outcomes measured at 90 and 180 days. Assessments include monitoring of clinical events, medication optimization, and healthcare utilization. The follow-up period includes clinic visits and data collection to evaluate the impact of virtual care on recovery and health status after heart failure hospitalization.