Fredericksburg

Researchers are evaluating the anti-tumor activity of amivantamab combined with pembrolizumab and carboplatin compared to pembrolizumab, 5-fluorouracil (5-FU), and platinum therapy (carboplatin or cisplatin) in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial focuses on participants who have not received prior systemic treatment in the recurrent/metastatic setting. HNSCC is a type of cancer affecting the outer tissue layer of the mouth and throat and other head and neck regions. Participants will receive either amivantamab added to pembrolizumab and carboplatin or the standard care regimen of pembrolizumab, 5-FU, and a platinum agent (carboplatin or cisplatin). 5-FU will be given as an infusion over a 4-day period. The study is a phase 3, randomized, open-label, multicenter trial comparing these treatment combinations. During the study, researchers will monitor overall survival and the objective response rate using standard tumor evaluation criteria for up to about 3 years and 7 months. Participants will undergo assessments to measure disease response, including imaging and other evaluations, to track how well the treatments work. Safety and side effects will also be monitored throughout the trial period.

Researchers are evaluating the effects of different doses of SAR442970 compared to placebo in adults with moderate to severe Crohn's disease. This phase 2b, randomized, double-blind study aims to assess the safety and effectiveness of SAR442970 in treating this condition. Participants must have had Crohn's disease for at least three months and have shown inadequate response or intolerance to previous standard or advanced therapies. Participants will receive either SAR442970 or placebo through subcutaneous injections during the treatment period, which lasts up to 158 weeks. Eligible participants may continue into an open-label long-term extension phase for up to 104 weeks. The study includes three treatment groups to compare different doses of SAR442970 with placebo. Throughout the study, participants will be closely monitored with various assessments to measure their response to treatment, including the percentage achieving endoscopic response by Week 16. Researchers will also monitor safety and collect data over a total duration of up to 168 weeks. Participants will have regular visits for evaluations, including clinical assessments and adherence to treatment protocols.

Researchers are conducting a Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of a topical spray called YJ001 in patients with diabetic peripheral neuropathic pain (DPNP) aged 18 to 80 years. The study takes place at a single center and involves two cohorts with different doses of YJ001. Equal numbers of male and female participants will be enrolled in each cohort to assess the treatment's effects. Participants will receive YJ001 as multiple sprays applied topically on both feet and below the ankles. On Days 1 and 2, a single dose is administered in the morning, followed by twice-daily doses (morning and evening) from Days 3 to 11. There are two dose levels: 296 mg per administration for Cohort M1 and 414 mg per administration for Cohort M2. Each cohort includes 12 subjects, with 10 receiving the active spray and 2 receiving placebo. Dose escalation decisions will be based on safety, PK, and other data reviewed after the first cohort completes treatment. Participants will be screened between 28 and 7 days before dosing, with pain scores recorded twice daily for 7 days prior to treatment. Subjects will stay at the clinic from the day before dosing through Day 17, undergoing safety, pharmacokinetic, and efficacy assessments during this period. Follow-up calls may occur 2 days after discharge to monitor any adverse events or medication use. Safety assessments include tracking adverse events, abnormal lab values, and skin reactions over about one year.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved treatment alternatives. This Phase 3, multicenter, randomized, open-label study compares the Bria-IMT regimen combined with the checkpoint inhibitor Retifanlimab against treatment chosen by patients or physicians. The study also aims to assess the activity of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. Participants are initially randomized equally into three groups: Bria-IMT plus Retifanlimab, treatment of physician's choice (TPC), and Bria-IMT alone. After enrollment of 150 patients, the monotherapy group is discontinued, allowing crossover to combination therapy if needed, with subsequent randomization continuing between combination therapy and TPC. Treatment cycles for Bria-IMT with or without Retifanlimab occur every three weeks, including cyclophosphamide given 2-3 days before SV-BR-1-GM inoculations, SV-BR-1-GM administered intradermally, interferon injections at inoculation sites, and Retifanlimab infusions timed consistently each cycle. TPC is given according to standard care at each site using approved drugs including chemotherapy and targeted agents. Participants undergo imaging assessments every six weeks twice, then every eight weeks during treatment if disease is stable and no major safety issues arise. Safety and overall survival will be monitored up to 60 months. Eligibility requires confirmation of advanced breast cancer with prior therapies failed, and participants must have an ECOG performance status of 0 to 2 with expected survival of at least four months. The study includes comprehensive assessments, treatment monitoring, and long-term follow-up to evaluate outcomes and safety.

Researchers are studying a new medicine called PF-08634404 to see how well it works when combined with chemotherapy in adults who have extensive-stage small cell lung cancer (ES-SCLC), a fast-growing cancer that has spread widely in the body. This study includes two parts: the first checks the safety and tolerability of PF-08634404 with chemotherapy, and the second compares PF-08634404 plus chemotherapy to another approved treatment, atezolizumab plus chemotherapy, to determine which is more effective. Participants will receive treatments through intravenous (IV) infusions in repeated cycles. Some will continue with PF-08634404 alone after the initial combined treatment. The study involves two phases: Phase 2 focuses on safety and response rates, while Phase 3 evaluates overall survival. Treatments are given according to a schedule during these phases to monitor effects. During the study, participants will undergo medical tests to assess organ function and cancer response, including measuring tumor lesions. Researchers will track treatment-related side effects for up to 90 days after the last dose and follow overall survival for up to about two years after treatment ends. The total involvement includes assessments throughout treatment and extended follow-up to evaluate safety and effectiveness.