Wendouree

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the safety and tolerability of an investigational drug called elritercept, both alone and in combination with the JAK inhibitor ruxolitinib, in adults with myelofibrosis MF. The study also aims to understand how elritercept affects the signs and symptoms of MF, how the body processes the drug, and its effects on anemia when used with or without ruxolitinib. This is a Phase 2 open-label study focusing on participants with anemia related to MF.

Researchers are studying the safety and tolerability of elritercept in adults with anemia linked to very low, low, or intermediate risk Myelodysplastic Syndromes MDS. The study aims to understand how elritercept affects red blood cell production and the progression of MDS, including how well participants tolerate different doses of the drug. This phase 2, open-label trial focuses on anemia associated with lower-risk MDS and evaluates the impact on healthy red blood cell production. Participants receive elritercept as a subcutaneous injection every 4 weeks, with doses ranging from 0.75 mgkg to 5.0 mgkg during an initial period of up to 4 cycles each 28 days. Following this, participants continue treatment with elritercept every 4 weeks for up to 24 cycles, with dose adjustments based on individual response. Different cohorts include participants with or without ring sideroblasts, those requiring red blood cell transfusions, and those with chronic myelomonocytic leukemia CMML. Some participants may enter a long-term extension phase receiving elritercept every 4 weeks for up to about 10 years. During the study, participants undergo regular monitoring including blood tests, assessments of red blood cell parameters, and tracking of adverse events and disease progression. Researchers measure treatment-emergent adverse events, progression to higher-risk MDS or acute leukemia, transfusion independence, and hematologic improvements over up to 11 years. The study includes follow-ups to evaluate the duration and timing of responses, safety, and overall effects on anemia and MDS progression.

Researchers are evaluating mavorixafor, a drug being studied for people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These conditions cause low neutrophil levels and lead to recurrent or serious infections. The study aims to show if mavorixafor can improve clinical outcomes and increase neutrophil counts, while also assessing its safety and tolerability. Participants will continue their current treatment during the study, which may include therapies like granulocyte-colony stimulating factor G-CSF, immunoglobulin replacement, antibiotics, or no active treatment. They will be randomly assigned to receive either mavorixafor or a placebo orally once daily for up to 52 weeks. The study uses a quadruple-blind design to compare these groups in parallel. During the trial, participants will have regular assessments to monitor infection rates and severity, neutrophil counts, antibiotic use, oral ulcers, and fatigue levels using questionnaires. An independent committee will review infections to ensure accuracy. Safety and treatment effects will be followed throughout the 52-week treatment period. The total participation may last until the study ends in late 2027.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating Tinodasertib, alone or combined with Pembrolizumab or Irinotecan, in patients with locally advanced or metastatic colorectal cancer CRC. This Phase 2 open-label study aims to find the best dose of Tinodasertib and assess its safety, tolerability, and clinical activity when given with these drugs. The study includes patients who have previously received treatment for CRC and focuses on understanding how these combinations work in this patient group. The study is divided into two parts. The first part is a dose escalation phase to find the maximum tolerated dose MTD and recommended Phase 2 dose RP2D of Tinodasertib given orally every other day, alone or with intravenous Pembrolizumab every three weeks or Irinotecan every two weeks. The second part expands on this by treating patients at the RP2D with Tinodasertib plus either Pembrolizumab or Irinotecan to evaluate clinical activity and safety more thoroughly. Participants will undergo regular assessments including monitoring for adverse events, serious side effects, and treatment responses using RECIST criteria. The study will track these outcomes for about two years after enrollment. Additional evaluations include pharmacokinetic studies about six months after enrollment. Patients will provide tumor tissue samples and have their disease measured by imaging. The study includes safety monitoring and follows patients closely throughout their participation.

Researchers are evaluating the effectiveness and safety of two combination treatments for adults with hormone receptor positive HR, human epidermal growth factor receptor 2 negative HER2- locally advanced or metastatic breast cancer that has a PIK3CA mutation. These patients have experienced recurrence or progression after treatment with a CDK46 inhibitor. This Phase 3, open-label, randomized study compares RLY-2608 zovegalisib plus fulvestrant against capivasertib plus fulvestrant to determine which treatment better controls the disease. Participants are assigned to one of two groups one group receives zovegalisib orally twice daily along with fulvestrant administered by injection on specific days during a 28-day treatment cycle the other group receives capivasertib orally twice daily on an intermittent weekly schedule plus fulvestrant injections on the same schedule. Treatment cycles repeat every 28 days. The study is conducted globally at multiple centers and continues until disease progression or other criteria are met. During the study, participants undergo regular assessments including scans reviewed by blinded independent central review to measure progression-free survival, as well as monitoring overall survival, response rates, quality of life questionnaires, and safety evaluations. Blood samples are taken periodically to measure drug levels. The study may last up to approximately 77 months for outcome measurements, with ongoing monitoring for adverse events and quality of life changes throughout this period.