Bucks County

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating the combination of tucatinib with Doxil in participants who have HER2-positive locally advanced or metastatic breast cancer. This Phase 2, open-label study focuses on understanding how well this treatment works and learning about its side effects in patients who have already received at least one prior anti-HER2 therapy. Participants will receive tucatinib orally at 300 mg twice daily continuously in 28-day cycles, along with Doxil given intravenously at 40 mgm2 on the first day of each cycle. The study begins with a safety lead-in phase for the first 6 patients monitored weekly for 28 days to check tolerability. If no severe toxicities occur, enrollment will continue up to 36 participants. Throughout the study, researchers will assess tumor response using RECIST v1.1 criteria over roughly 40 months. They will also monitor side effects, progression-free survival, and other health measures. Participants will undergo regular clinical evaluations, imaging scans, and lab tests. Safety will be closely tracked during treatment and for 30 days after the last dose, with follow-up visits scheduled as needed.

Researchers are studying a new medicine called PF-08634404 combined with chemotherapy in people 18 years and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This study aims to understand how well this combination works and how safe it is compared to another approved treatment, nivolumab plus chemotherapy, in those who have not yet received treatment for advanced disease. Participants will receive intravenous PF-08634404 combined with chemotherapy in repeated treatment cycles. The study has two parts the first part focuses on safety and response to the new treatment, and the second part compares the new treatment plus chemotherapy against nivolumab plus chemotherapy. Treatments are given intravenously, and the study lasts approximately four years to monitor effects and outcomes. During the study, participants will be regularly monitored with medical tests to assess tumor response, side effects, survival, and quality of life. Researchers will collect data on tumor shrinkage using RECIST 1.1 criteria, adverse events, laboratory results, and serum levels of the study drug. Follow-up includes assessments up to 90 days after treatment ends. The total participation duration spans about four years, covering both treatment and observation periods.