Midland

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT andor MRI scans, and optical coherence tomography OCT. Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the First To Know4 Pregnancy test, an investigational device adapted from the FDA-cleared ADEXUSDx4 hCG test, for potential over-the-counter use by lay users in a simulated home setting. The study involves females with unknown pregnancy status across different age groups, including pre-menopausal, peri-menopausal, and post-menopausal women, assessing how well the test performs compared to standard blood-based pregnancy tests. The study is organized into two cohorts Cohort A, which includes up to 100 pregnant participants divided into three age groups, will perform self-testing and provide blood samples for comparison with a reference method. Cohort B consists of a subset of Cohort A participants who will perform duplicate self-tests consecutively to evaluate the tests accuracy and precision. Participants will test themselves and interpret results independently without assistance. Participants will self-administer the pregnancy test and provide blood samples for comparison. Negative results will be followed up to confirm pregnancy status, and positive results will be verified using standard care data. The study will track outcomes over an average of six months, measuring the tests accuracy, sensitivity, specificity, usability, and precision in real-world conditions. Participants will also provide information about their pregnancy diagnosis from their healthcare providers follow-up visits.

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.

This research aims to understand the role of unusual proteins, cytokines, and vaginal microbial flora in causing vulvodynia, recurrent fungal and bacterial vaginosis, and preterm labor. The study compares these factors in different groups of women to uncover how changes in the vaginal environment might lead to symptoms like irritation, pain, and infection recurrence, as well as premature birth. Researchers will use a multidisciplinary approach involving microbiology, proteomics, and cytokine analysis to explore these mechanisms. Participants include four groups of women aged 21 to 75 years healthy non-pregnant women without a history of vulvovaginal conditions, non-pregnant women with vulvovaginal issues, healthy pregnant women, and pregnant women with vulvovaginal conditions. Vaginal samples will be collected using cotton swabs from the middle vagina, processed for microbiological and biochemical testing including cytokine and protein levels. Pregnant women will have samples collected up to four times over 12 months. During the study, participants will provide informed consent and complete a comprehensive history related to environmental factors and vulvovaginal health. Researchers will measure cytokines, proteins, and vaginal lactobacillus levels from collected samples. Data will be kept confidential and stored securely. The main outcome is cytokine determination, with secondary outcomes including protein and lactobacillus analysis. The study aims to create a data bank to support future research, with participation lasting according to sample collection schedules.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.

Researchers are evaluating whether a new medicine called PF-08634404, given with chemotherapy, works better than the current standard treatment of pembrolizumab combined with chemotherapy for adults with a type of lung cancer known as non-small cell lung cancer NSCLC. This study focuses on participants with locally advanced or metastatic NSCLC who are not candidates for surgery or curative chemoradiotherapy and have no known actionable genomic alterations. The study is a Phase 3 randomized trial with double-blind masking to compare these treatments. Participants are assigned to one of two parts based on their tumor type those with squamous NSCLC are in Part 1, and those with non-squamous NSCLC are in Part 2. Each participant is randomly placed into one of two treatment groups the experimental group receives PF-08634404 plus chemotherapy, while the control group receives pembrolizumab plus chemotherapy. Treatments are given through intravenous infusions in cycles, followed by maintenance therapy with either PF-08634404 or pembrolizumab, depending on the part of the study. Participants continue treatment as long as it helps and side effects are manageable. During the study, participants attend regular visits for treatment and health assessments. Cancer response is checked every 6 weeks for the first 48 weeks and then every 12 weeks after that. Researchers monitor overall survival, progression-free survival, objective response rates, duration of response, adverse events, lab abnormalities, and quality of life measures. The study includes detailed tracking of drug levels and immune responses. Participation may last up to approximately 39 months, with continuous safety and effectiveness monitoring.