Bucks County

Researchers are evaluating petosemtamab compared with investigator's choice monotherapy in patients with incurable, metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) who have previously received treatment. This phase 3 open-label, randomized, controlled, multicenter study focuses on patients whose disease progressed after anti-PD-1 and platinum-containing therapies. The study aims to assess treatment options for second- and third-line therapy in this challenging condition. Participants will be randomly assigned to receive either petosemtamab or one of several investigator-chosen monotherapies, including cetuximab, methotrexate, or docetaxel. The study compares these treatment approaches without masking, allowing patients and researchers to know the assigned therapies. Treatments will be provided according to the study protocol, with follow-up to monitor effects and safety. During the study, participants will undergo assessments including radiologic evaluations to measure tumor response, laboratory tests to monitor organ function, and quality of life questionnaires. The main outcome is overall survival tracked for up to about three years, with additional measures such as response rate, progression-free survival, and treatment-related side effects observed for up to two years. Safety will be closely monitored, including adverse events and antibody responses, ensuring comprehensive evaluation throughout the study period.

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 evaluating the safety and effectiveness of giredestrant compared to fulvestrant, both combined with a CDK4/6 inhibitor, in adults with estrogen receptor-positive (ER+), HER2-negative advanced breast cancer who have developed resistance to prior adjuvant endocrine therapy. This Phase III, randomized, open-label study focuses on participants whose cancer is locally advanced or metastatic and not curable by surgery or other treatments. Participants are randomly assigned to one of two groups. The experimental group receives giredestrant 30 mg orally once daily in 28-day cycles plus an investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib). The control group receives fulvestrant 500 mg by injection on specified days in 28-day cycles plus a chosen CDK4/6 inhibitor. Pre/perimenopausal women and men also receive an LHRH agonist during treatment. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will undergo evaluations including confirmation of ESR1 mutation status, disease measurement according to RECIST criteria, and monitoring of adverse events, vital signs, and laboratory tests. Researchers will assess progression-free survival, overall survival, response rates, pain severity, physical functioning, and quality of life over up to 5 years. Safety monitoring extends to 28 days after treatment ends, with ongoing data collection on clinical outcomes and treatment effects.

Researchers are evaluating the medicine PF-08046054 compared to the standard treatment docetaxel for adults with non-small cell lung cancer (NSCLC) that has PD-L1 expression of 1% or higher. This study focuses on participants whose cancer has spread or cannot be removed by surgery or treated with radiation, and who have progressed after treatment with PD-L1 or PD-1 inhibitors, platinum chemotherapy, and targeted therapies when applicable. The study is a randomized, phase 3 trial sponsored by Pfizer. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will have an intravenous infusion twice every 21 days, while those in the docetaxel group will receive one infusion every 21 days. Treatment may continue for up to five years if the cancer responds well. The treatments are given in cycles with close monitoring. During the study, participants will visit the clinic regularly for evaluations to monitor their health and response to the study treatments. Researchers will assess overall survival over about five years and track disease progression, response rates, duration of response, and quality of life measures. Safety will be monitored through adverse event reporting for up to 90 days after treatment ends. Additional blood tests will measure drug levels and antibody responses during the first year of treatment.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy in people aged 18 and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study focuses on participants who have not previously received treatment for advanced disease and have good overall health, including healthy organs. This study includes two phases: the first assesses safety and response to the new medicine with chemotherapy, and the second compares this combination to an existing treatment of nivolumab plus chemotherapy. In the first phase, participants receive PF-08634404 intravenously with chemotherapy to evaluate safety and how well they respond. In the second phase, participants are randomly assigned to receive either PF-08634404 plus chemotherapy or nivolumab plus chemotherapy, both given intravenously. Treatments are given in repeated cycles. The study uses a double-blind design to compare outcomes between these groups over approximately four years. Participants will undergo regular assessments including scans to measure tumor response using RECIST 1.1 criteria, monitoring for side effects and laboratory abnormalities, and blood tests to measure drug levels and immune response. Researchers will also track progression-free survival, overall survival, and quality of life using specific questionnaires for gastric cancer. Safety monitoring continues through 90 days after the last treatment, with overall participation lasting about four years.

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 mg/m2 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.