Makati City

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating quabodepistat-containing treatment regimens for adults and adolescents aged 14 years and older with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis RRMDR-TB. The study aims to determine if adding quabodepistat to other TB drugs can shorten treatment duration to 4 months for fluoroquinolone-sensitive TB and provide a safer alternative compared to the current 6-month WHO-endorsed regimens. This Phase 3, randomized, open-label trial also compares treatments for patients with fluoroquinolone-resistant TB. Participants will be divided into two main groups based on fluoroquinolone sensitivity. Those with fluoroquinolone-sensitive RRMDR-TB will receive either an experimental 4-month regimen BPaQM bedaquiline, pretomanid, quabodepistat, moxifloxacin or a 6-month control regimen BPaLM bedaquiline, pretomanid, linezolid, moxifloxacin. Those with fluoroquinolone-resistant RRMDR-TB will receive either an experimental 6-month regimen BPaQ bedaquiline, pretomanid, quabodepistat or a control 6-month regimen BPaL bedaquiline, pretomanid, linezolid. Dosing schedules vary by regimen and last either 4 or 6 months. During the 16-month follow-up, participants will undergo regular assessments including sputum samples, chest X-rays, laboratory tests, and safety evaluations. Researchers will measure treatment effectiveness by the proportion with unfavorable outcomes 12 months after randomization and monitor adverse events. Additional outcomes include time to sputum culture conversion, microbiological relapse, and drug plasma levels. Safety will be closely monitored throughout treatment and follow-up periods.

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 a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

This research aims to collect detailed eye measurements and data on aberrations using a new device called Unity DX. The study is observational, involving four different groups of participants with cataracts, including those with previous lens implants, planned lens implants, prior refractive surgery, or keratoconus, a cornea disorder. The study is conducted across multiple centers in India, Spain, and the Philippines. Participants will undergo noninvasive, noncontact eye measurements using the Unity DX and SMARTCataract DX SCDX Biometer along with either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer, depending on the site. These devices capture detailed 3D eye models, optical biometry, and topography data. Each group will follow specific measurement schedules, including preoperative and postoperative time points for some groups. During the study, participants will have their eye measurements recorded at various visits according to their group. Data collection includes manifest refraction spherical equivalent MRSE measurements at baseline and postoperative intervals. Researchers will monitor and analyze this information to better understand eye biometry and aberrations. The study involves consenting adults willing to attend scheduled visits, with the total participation timeframe depending on the group and measurement schedule.

Researchers are evaluating the performance and safety of the JASPER Robotic Surgical System during cataract surgery in adults aged 55 to 80 years. This prospective, open-label clinical study focuses on how well this robotically assisted device helps ophthalmic surgeons perform cataract procedures. Participants will undergo cataract surgery using the JASPER Robotic Surgical System. This device is designed to assist surgeons during the operation. The study follows patients from surgery through 30 days after the procedure to monitor outcomes and safety. During the study, participants will have their surgeries performed with the robotic system and then be monitored for successful completion of the surgery, any adverse events, and changes in visual acuity. Postoperative eye examinations will be conducted up to 30 days after surgery to assess recovery and safety. The total participation lasts from surgery through this 30-day follow-up period.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating a new skin barrier product containing ceramide, virgin coconut oil, and cholesterol to treat adults with skin barrier dysfunction, including mild to moderate psoriasis, atopic dermatitis, contact dermatitis, seasonal xerosis, or clinically evident skin dryness. This pilot randomized controlled trial compares the new product to petrolatum, a standard treatment, to assess effects on skin hydration, sebum, redness, pigmentation, and symptoms like dryness and itch. Participants will apply either the novel barrier product or petrolatum twice daily on the right forearm for 28 days. They will receive supplies of the assigned product in identical containers to keep the study blinded. Follow-up visits occur weekly at weeks 1, 2, and 4, where researchers will measure skin condition and collect questionnaires. Participants will also keep a diary of product application. During each visit, non-invasive tests will measure skin hydration, sebum, redness, and pigmentation using specialized devices. Participants will rate their dryness and itch levels using a visual scale and complete satisfaction questionnaires. Researchers will monitor for any adverse skin reactions. The total participation lasts 28 days with assessments at multiple time points to evaluate safety and effectiveness.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.