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Researchers are studying a drug called sigvotatug vedotin (SGN-B6A) alone and combined with pembrolizumab, with or without chemotherapy, to evaluate its safety and effects in people with advanced solid tumors. The study aims to identify side effects and understand how well the drug works to treat various solid cancers. It is a Phase 1 trial conducted in multiple parts to explore different doses and treatment combinations. The trial includes four parts: Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to assess safety and activity against tumors. Parts C and D examine the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with carboplatin or cisplatin chemotherapy drugs. Participants receive these treatments intravenously, with dosage schedules specific to each drug. During the study, participants will undergo tumor biopsies, imaging scans, and clinical assessments to measure treatment responses and side effects. The research team will monitor adverse events, laboratory results, and specific measures of drug concentration in the blood over up to three years. This long-term follow-up helps researchers understand the drug’s impact and safety over time for participants with various solid tumor types.

Researchers are evaluating the safety and effectiveness of the drug GDC-4198 alone and combined with giredestrant compared to abemaciclib plus giredestrant in people with locally advanced or metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The study includes two phases: Phase Ib focuses on safety and how the body processes GDC-4198 alone and with giredestrant, while Phase II compares the activity and safety of GDC-4198 plus giredestrant against abemaciclib plus giredestrant. Participants have previously experienced disease progression during or after treatment with a CDK4/6 inhibitor and endocrine therapy. Participants receive treatments orally in 28-day cycles until unacceptable side effects, disease progression, or loss of clinical benefit. In Phase Ib, GDC-4198 is given alone or combined with giredestrant at varying doses. In Phase II, participants are randomly assigned to receive GDC-4198 with giredestrant at higher or lower doses, or abemaciclib with giredestrant. Dosing is daily, with abemaciclib taken twice daily at 150 mg. Participants will be monitored for up to 36 months, with assessments including safety evaluations, measuring side effects, disease progression, response rates, duration of response, overall survival, and drug concentrations in the blood. Researchers will track adverse events, dose-limiting toxicities, and progression-free survival. Study visits will include physical exams, laboratory tests, and imaging to evaluate tumor status and treatment effects throughout the study period.

Researchers are evaluating combination therapies involving adagrasib with pembrolizumab and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation and varying levels of PD-L1 expression. This Phase 2 open-label trial focuses on first-line treatment for patients with tumors showing PD-L1 tumor proportion scores (TPS) of 1% or higher, including those with TPS below 50%. The study aims to assess clinical responses and progression-free survival in this specific population. Participants receive adagrasib orally at 400 mg twice daily, combined with pembrolizumab given intravenously every three weeks, with treatment duration varying by cohort. Some cohorts also include chemotherapy agents such as pemetrexed, cisplatin, or carboplatin administered every three weeks. Treatment regimens differ across three cohorts, with some participants receiving adagrasib alone initially, followed by combination therapy, and others receiving concurrent combination treatments for up to 31 or 35 cycles. During the study, participants undergo evaluations including imaging to measure tumor response according to RECIST criteria, safety monitoring for adverse events, and pharmacokinetic assessments. The main outcomes measured are objective response rate and progression-free survival at six months, with additional monitoring of overall survival and duration of response. The study lasts up to 30 months, providing detailed data on treatment effects and safety in this patient group.

Researchers are evaluating the use of a cellular, acellular, matrix-like product called Amnio-Maxx4 Dual Layer Amnion Patch alongside the Standard of Care (SOC) compared to SOC alone for closing nonhealing diabetic foot ulcers (DFUs). This Phase 4 randomized controlled trial focuses on adult patients with chronic DFUs to better understand how Amnio-Maxx may affect healing rates. Participants will receive either the Standard of Care, which includes cleansing, debridement, wound documentation, and off-loading, or the Standard of Care plus the application of the Amnio-Maxx Dual Layer Amnion Patch. The study uses random assignment without masking. Treatments are applied during study visits, and the ulcer is carefully monitored for closure and healing progress. During the 12-week trial, participants will undergo assessments including ulcer measurements to evaluate complete closure and percentage area reduction. Pain related to the ulcer will be tracked using the Numeric Pain Rating Scale. Researchers will also monitor adverse events throughout the study. Participants must follow treatment protocols and attend regular visits to support accurate evaluation of outcomes related to healing diabetic foot ulcers.

This trial is studying adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that affects the nerves. Researchers are evaluating the safety and effectiveness of nipocalimab compared to a placebo in delaying the return of symptoms in patients who initially respond to nipocalimab treatment. The study is designed as a Phase 2/3, randomized, double-blind, placebo-controlled trial. Participants first enter Stage A, where everyone receives nipocalimab intravenously, with a loading dose on Day 1 followed by doses every two weeks for 12 weeks. Those who show improvement then move to Stage B, where they are randomly assigned to receive either nipocalimab or a placebo intravenously every two weeks for up to 52 weeks. After Stage B, participants may join an open-label extension phase to receive nipocalimab every two weeks for up to two years or until the drug becomes commercially available. Throughout the study, participants will have regular assessments including disability and muscle strength scales, grip strength measurements, and monitoring for any adverse events or changes in laboratory tests, vital signs, and electrocardiograms. The main outcome measured is the time until the first relapse during Stage B over 52 weeks. Safety and antibody responses to the drug are also closely monitored. The total participation time can extend up to two years depending on the study phase and extension.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved alternative therapies available. This Phase 3, multicenter, randomized, open-label study compares a new combination treatment called the Bria-IMT regimen plus a checkpoint inhibitor (Retifanlimab) against treatment chosen by patients and their physicians. The study also aims to assess the effectiveness of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. The study includes three initial groups: one receiving Bria-IMT plus Retifanlimab, one receiving physician's choice treatment (such as eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine, or taxanes), and one receiving Bria-IMT alone. After enrolling 150 patients, the Bria-IMT alone group will be stopped, and those patients may switch to the combination therapy. Treatment cycles for Bria-IMT arms occur every three weeks, with imaging assessments every six weeks twice, then every eight weeks if no disease progression or safety concerns arise. Participants will undergo various assessments throughout the study, including imaging and clinical evaluations, to track overall survival up to 60 months. Secondary outcomes include progression-free survival, clinical benefit rate, overall response rate, quality of life, and central nervous system event-free survival. Safety and treatment effects will be monitored continuously, and participants may be followed for up to five years after starting treatment.

Researchers are studying a new medicine called PF-08634404 to see how well it works for adults with colorectal cancer that has spread to other parts of the body. This trial aims to find out if combining PF-08634404 with approved chemotherapy helps compared to using another approved medicine, Bevacizumab, combined with chemotherapy. The study is a phase 3, double-blind, randomized trial focused on treatment-nafve participants with metastatic colorectal cancer. Participants will be randomly assigned to one of two groups: one group will receive PF-08634404 plus chemotherapy, and the other will receive Bevacizumab plus chemotherapy. Both treatments are given through intravenous (IV) infusions at a clinical site. Treatments are given in cycles, and participants can continue treatment as long as it is helping and side effects are manageable. During the study, participants will have regular visits for treatment, health checks, and tests. After stopping treatment, there will be a final visit about 30 to 37 days later to evaluate health and side effects. Follow-up will continue every 12 weeks by phone, in person, or by reviewing health records. The study is expected to last about 33 months per participant. Researchers will measure outcomes like progression-free survival and overall survival over approximately 4 years, along with response rates, duration of response, quality of life, and safety assessments.

Researchers are conducting a multicenter, randomized, open-label phase 3 trial to evaluate treatments for patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitors (ICI). The study focuses on patients positive for the HLA-A2 phenotype with either squamous or non-squamous histology. The trial compares the cancer vaccine OSE2101 to the standard chemotherapy drug docetaxel. Stratification factors include cancer histology and the patients' performance status. Participants will be randomly assigned in a 2:1 ratio to receive either OSE2101 or docetaxel. OSE2101 is a peptidic cancer vaccine given by subcutaneous injection every three weeks for six cycles, then every eight weeks through the first year, and every twelve weeks during the second year. Docetaxel is given as an intravenous infusion every three weeks. Additionally, a companion diagnostic device system is used to detect HLA-A2 status and analyze genetic markers. During the study, patient survival will be monitored from the time of randomization for an average of three years. Researchers will track overall survival as the primary outcome. Patients will undergo regular treatment visits, assessments, and monitoring according to the schedule. Safety, efficacy, and disease progression will be evaluated throughout the trial period, which starts in December 2024 and continues until December 2028.