Fredericksburg

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been treated with systemic therapy before. The study compares the anti-tumor effects of amivantamab combined with pembrolizumab and carboplatin against pembrolizumab with 5-fluorouracil and platinum therapy carboplatin or cisplatin. Participants have HNSCC in the oral cavity, oropharynx, hypopharynx, or larynx but not nasopharynx or unknown primary tumor sites, and HPV status is considered for oropharynx cases. Participants are randomly assigned to one of two groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other receives pembrolizumab, 5-fluorouracil given as a 4-day infusion, and carboplatin or cisplatin. Treatments are given according to standard protocols for these drugs. The study is open-label and conducted across multiple centers. During the trial, participants will be monitored for overall survival and tumor response using established criteria up to about 3 years and 7 months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires specific to head and neck cancer, and safety evaluations through adverse event and lab test monitoring. Blood samples will check amivantamab levels and antibodies. Participation involves regular visits for treatment and assessments throughout the study period.

Researchers are evaluating SAR442970, a drug given by injection under the skin, for adults with moderate to severe Crohns disease. This phase 2b, randomized, double-blind study compares two different doses of SAR442970 with placebo to understand its effects on the condition. The study aims to measure how many participants achieve an endoscopic response by Week 16, among other clinical improvements. Participants are randomly assigned to receive one of three treatments SAR442970 dose regimen A, SAR442970 dose regimen B, or placebo. Treatments are given subcutaneously, and the study includes a treatment period lasting up to 158 weeks. There is also an open-label long-term extension phase lasting up to 104 weeks for those who qualify, allowing continued evaluation of SAR442970s effects over time. During the study, participants will undergo assessments including endoscopic exams, clinical remission evaluations using the Crohns Disease Activity Index CDAI, patient-reported outcomes, and quality-of-life questionnaires. Safety is monitored by tracking adverse events and measuring drug levels in the blood. The total participation time can be up to 168 weeks, with ongoing evaluations to assess both short- and long-term outcomes.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of a topical spray called YJ001 for patients with diabetic peripheral neuropathic pain DPNP. This Phase I, randomized, double-blind, placebo-controlled study includes adults aged 18 to 80 years and is conducted at a single study center. The study involves two dose levels and aims to assess multiple ascending doses applied topically to both feet and below the ankles. Participants are assigned to one of two cohorts receiving either 296 mg or 414 mg doses of YJ001, each cohort including 12 subjects with 10 receiving the active spray and 2 receiving placebo. The treatment is administered as multiple sprays on both feet once in the morning on Days 1 and 2, then twice daily morning and evening from Days 3 to 11. The Safety Review Committee evaluates safety and pharmacokinetics data after each cohort to decide on dose escalation or other study actions. Before starting treatment, subjects undergo screening and a baseline pain rating period from Day -7 to Day -1. They stay in the clinic from Day -1 through Day 17 for treatment and observation, with follow-up by phone 2 days after discharge. Researchers monitor safety through adverse events, laboratory tests, and skin reactions for about one year. Pharmacokinetics and efficacy are assessed through various measurements during and after dosing, ensuring detailed evaluation of the treatments effects and tolerability.

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.

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 physicians 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 evaluating a new medicine called PF-08634404 combined with chemotherapy in adults with extensive-stage small cell lung cancer ES-SCLC, a fast-growing type of lung cancer that has spread widely. The study aims to learn how well PF-08634404 works when given with chemotherapy compared to an approved treatment called atezolizumab plus chemotherapy. The study is conducted in two phases to assess safety, tolerability, and effectiveness of the treatments. Participants will receive treatments through intravenous IV infusions in repeated cycles. In the first phase, the focus is on safety and tolerability of PF-08634404 with chemotherapy. The second phase compares PF-08634404 plus chemotherapy to atezolizumab plus chemotherapy. Some participants may continue receiving PF-08634404 alone after the initial combination treatment. Treatments are delivered as IV infusions during scheduled cycles. During the study, participants will undergo medical tests to monitor their health and cancer status. Researchers will assess response rates, survival times, progression-free survival, and quality of life using standard measurement criteria. Safety will be closely monitored through tracking adverse events and laboratory tests. The study lasts up to around two years after the last participant completes treatment, with regular visits for assessments and follow-up.