Centennial

Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.

Researchers are evaluating the long-term safety of lonapegsomatropin in children with growth hormone deficiency who are already being treated with this medication. This study is observational and aims to gather real-world safety data over time after the drug has been authorized for use. The focus is on monitoring potential risks such as the development of tumors and type 2 diabetes over a period of five years. Participants receive lonapegsomatropin, administered once weekly by subcutaneous injection as part of their usual care. The study does not involve additional interventions but observes patients who are already treated with this therapy. The observational period extends for at least five years to collect safety data and compare it with historical information from previous studies. During the study, researchers will monitor for the occurrence of benign and malignant tumors, type 2 diabetes, and other adverse events affecting the kidneys, liver, immune system, and nervous system. They will also track medication errors and measure the response of Insulin-like Growth Factor-1 IGF-1 to treatment. Participants are followed up regularly to collect this information, with the study lasting until March 2033.

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 treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

Researchers are evaluating the effects of elismetrep, an oral drug, compared with a placebo for the acute treatment of migraine in adults aged 18 to 75. This phase 3, double-blind, randomized study is conducted at multiple centers to assess the drugs safety, tolerability, and effectiveness in relieving migraine symptoms quickly. Participants receive either 10 mg or 20 mg of elismetrep or a placebo orally as part of the trial. The study uses a parallel design where participants are randomly assigned to one of these groups and neither the participants nor the researchers know which treatment is given until the study ends. During the trial, participants will be monitored for migraine pain relief and freedom from bothersome symptoms two hours after dosing, among other outcomes. Researchers will also assess pain relief at various time points, use of rescue medication, and safety by tracking any adverse events. Participants will complete questionnaires and use an eDiary app to record their experiences. The study is expected to last until February 2027.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

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 studying the effectiveness of riliprubart compared to intravenous immunoglobulin IVIg in adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP who are already receiving IVIg maintenance treatment. This Phase 3 trial aims to evaluate how well riliprubart works and its safety over a study period lasting up to 109 weeks, including screening, treatment, and follow-up phases. Participants are randomly assigned to one of two groups one receives riliprubart along with a placebo IVIg infusion for 24 weeks, followed by a 24-week open-label extension phase where all receive riliprubart the other group continues IVIg treatment with a placebo riliprubart for 24 weeks, then also enters the open-label extension phase receiving riliprubart. The study uses intravenous and subcutaneous solutions for administration and includes a double-blind design to compare treatments fairly. During the study, participants undergo various assessments including disability scales, grip strength measurements, fatigue scales, and health quality evaluations from baseline up to week 48 and beyond. Researchers will monitor treatment responses, relapses, adverse events, and immune responses throughout the trial. Participants are followed closely for safety and effectiveness until the study concludes, with total involvement lasting up to 109 weeks.

This research aims to gather long-term evidence on the safety and effectiveness of SKYTROFA lonapegsomatropin in patients with growth hormone deficiency who are receiving routine clinical care. The study focuses on understanding how patients respond to this treatment over time without altering their usual medical management. It is a non-interventional observational study conducted across multiple centers in the USA. Patients will continue their regular treatment with SKYTROFA as managed by their healthcare providers, with no additional visits, examinations, or tests required beyond standard clinical care. The study will collect data from clinical outcome assessments COAs to evaluate treatment results and safety over a period of five years. No experimental interventions or placebos are involved. Participants will be monitored through their routine clinical visits, with researchers reviewing their health status and treatment effectiveness using standard assessments. The primary outcomes include measuring safety and treatment effectiveness over five years, along with evaluating clinical outcomes through COAs. This approach allows for natural observation of patient experiences without extra procedures or disruptions to their care.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.