Bullhead City

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

Researchers are evaluating the safety, tolerability, and clinical activity of an unconjugated belantamab antibody alone and in combination with other treatments for people with refractory multiple myeloma RRMM. This study includes participants who have had several prior therapies, including a proteasome inhibitor, lenalidomide, and an anti-CD38 monoclonal antibody. The trial has three parts focusing on different combinations and dosages to better understand how these treatments work in this condition. Participants will receive one of several treatments depending on the study part in Part 1, they receive escalating doses of the unconjugated belantamab antibody alone in Part 2, the antibody is combined with a fixed dose of belantamab mafodotin, given as separate drugs and in Part 3, the antibody is combined with a pomalidomide-dexamethasone standard care backbone. Treatment in Parts 1 and 2 continues until disease progression, after which participants may opt to receive belantamab mafodotin alone. During the study, participants are monitored for adverse events and dose-limiting toxicities, as well as changes in laboratory and vital signs parameters. Researchers also track ocular events using a specific visual acuity scale. The study measures treatment responses, including overall response rates and very good partial response rates, along with drug levels in the blood. Participants are followed for up to 52 months to assess treatment effects and safety under medical supervision throughout the trial.

Researchers are evaluating the effectiveness of trastuzumab deruxtecan T-DXd in patients with HER2-positive IHC 3 locally advanced, unresectable, or metastatic solid tumors in the United States. This observational study focuses on patients who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options. The study excludes patients with breast, colorectal, non-small cell lung cancer, gastricgastroesophageal junction cancers, and hematological malignancies. Participants will be enrolled at approximately 30 sites including community oncology practices, hospital systems, and academic medical centers. They will start treatment with T-DXd as part of routine clinical care according to the FDA label. The study is designed to reflect real-world clinical practice and will observe patients from the point they begin T-DXd treatment. During the study, researchers will collect data on tumor response and treatment outcomes over up to 2.5 years after enrollment. They will assess real world response rate, duration of response, time to treatment discontinuation, and time to next treatment. Participants clinical progress and outcomes will be monitored through their usual healthcare visits, with no additional interventional procedures required for the study duration.

Researchers are evaluating the safety and effectiveness of Olvimulogene nanivacirepvec Olvi-Vec, an intravenously delivered oncolytic vaccinia virus, in combination with platinum-based chemotherapy and a physicians choice of immune checkpoint inhibitor ICI compared to docetaxel in patients with advanced or metastatic non-small-cell lung cancer NSCLC. This Phase 2, open-label, randomized study focuses on patients who have shown first disease progression while on front-line or maintenance ICI therapy following platinum-doublet chemotherapy. The study aims to test if Olvi-Vec can activate the immune system and make tumors more responsive to chemotherapy in NSCLC patients without certain targetable genetic alterations. Participants will be assigned to one of several groups. Initial cohorts receive varying doses of Olvi-Vec over 3 or 4 consecutive days, followed 2 to 3 weeks later by platinum-doublet chemotherapy combined with a physician-chosen ICI. The experimental arm will use the Olvi-Vec dose and schedule selected from these cohorts, followed by platinum-based chemotherapy plus ICI. The comparator arm receives docetaxel starting in week 0 and continuing until disease progression is confirmed. Patients in the comparator arm with disease progression may cross over to receive the experimental treatment if eligible. During the study, participants will undergo regular assessments including imaging scans to measure tumor response and progression-free survival up to 12 months after randomization. Researchers will monitor treatment safety and side effects for up to 36 months. Additional measures include overall survival, disease control rate, and treatment response duration. Scheduled visits will involve laboratory tests, imaging, and clinical evaluations to track health and disease status throughout the trial.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease CKD who are referred for creation of a new arteriovenous fistula AVF. This multi-center, prospective, randomized, double-arm, single-blind clinical trial involves about 600 participants across up to 30 sites. The purpose is to compare SelfWrap-assisted AVF creation with the standard surgical procedure without any additional intervention over a 36-month follow-up period. Participants are randomly assigned to one of two groups one receiving the SelfWrap device during AVF creation surgery, and the other undergoing the usual AVF surgery without intervention as a control group. The SelfWrap device offers mechanical support intended to improve the maturation and patency of the fistula. The trial follows participants for 36 months after surgery to monitor outcomes. During the study, participants will undergo assessments to measure unassisted maturation of the AVF at up to 6 months and monitor freedom from access-related adverse events through 30 days. Researchers will evaluate safety and effectiveness through these primary outcome measures. Participants are expected to comply with study requirements and attend follow-up visits throughout the 36-month period to allow comprehensive evaluation of the devices impact and any complications.

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.