Palmerston North

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are conducting a randomized, double-blind, placebo-controlled study to assess the safety and effectiveness of FB102 in adults with severe to very severe alopecia areata (AA). This condition involves significant hair loss, and the study focuses on patients with at least 50% scalp hair loss, including those with total scalp or complete body hair loss. The trial aims to better understand how FB102 may impact hair loss severity compared to placebo in this patient population. Up to about 32 participants will be randomly assigned in a 3:1 ratio to receive either FB102 or a placebo, both given through intravenous (IV) administration. Participants will receive the assigned treatment according to the study plan, with careful monitoring throughout the trial period. The study is designed to maintain blinding so neither participants nor researchers know who receives FB102 or placebo. Participants will be monitored for safety by tracking any treatment-related or serious adverse events up to 36 weeks after the first dose. The main effectiveness measure is the change from baseline in the Severity of Alopecia Tool (SALT) score at week 16, which assesses the extent of hair loss. The study includes screening, treatment, and follow-up assessments to evaluate these outcomes and ensure participant safety over the course of the trial.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with or without low-dose cyclophosphamide (CPA), in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This Phase 2b, randomized, open-label study aims to compare these treatments in patients who have previously received at least two lines of systemic therapy but whose disease has progressed. Participants will be randomly assigned to one of two groups: one group will receive DPX-Survivac, pembrolizumab, and intermittent low-dose CPA; the other group will receive DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two subcutaneous injections three weeks apart followed by up to twelve smaller doses every eight weeks. Pembrolizumab is administered by intravenous infusion every three weeks. For those in the CPA group, oral CPA is taken twice daily in a cycle of seven days on and seven days off, continuing throughout treatment. During the study, participants will be monitored for treatment response over approximately 24 months, focusing on the objective response rate in each group. Evaluations include tumor biopsies before and during treatment, laboratory tests, and disease assessments. Safety will be closely observed, and participants must have a life expectancy greater than three months to join. The study plans to enroll up to 102 subjects, with regular follow-up to track treatment effects and side effects.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) affects millions worldwide and is a leading cause of kidney failure. This research aims to evaluate whether metformin, a common diabetes medication, can be repurposed to slow kidney function decline in adults with early-stage ADPKD. The trial addresses the limited treatment options currently available and the significant impact of ADPKD on quality of life, anxiety, and depression. Participants will be randomly assigned to receive either extended-release metformin or a placebo with inactive tablets identical in appearance. This global Phase III study plans to enroll 1,174 adults aged 18 to 70 years diagnosed with ADPKD. The study will carefully monitor kidney function over 24 months to assess the effects of metformin on disease progression. During the study, participants will undergo evaluations including kidney function tests measured by estimated glomerular filtration rate (eGFR). Researchers will track changes over two years to determine if metformin slows kidney decline. Safety assessments and adherence monitoring will also be part of the study to ensure participant well-being throughout the trial period.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating whether combining the investigational drug mevrometostat (PF-06821497) with enzalutamide works better than enzalutamide alone in men with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received androgen receptor pathway inhibitors or chemotherapy in this setting. This Phase 3, randomized, double-blind, placebo-controlled study involves participants who have only received limited prior androgen-deprivation therapy and no evidence of disease progression before starting the study. Participants will be randomly assigned to one of two groups: one group receives oral mevrometostat together with oral enzalutamide continuously, while the other group receives a placebo with oral enzalutamide continuously. The study includes a Screening Phase, a Treatment Phase after randomization, followed by Safety Follow-up and Long-Term Follow-up periods to monitor outcomes and side effects. Throughout the study, participants will undergo regular assessments including imaging scans to evaluate disease progression, laboratory tests, and monitoring of symptoms and adverse events. The main outcome measured is Radiographic Progression Free Survival (rPFS) over approximately 4 years from randomization. Safety and long-term effects will also be monitored to understand how well participants tolerate the treatments and how the disease responds over time.

Researchers are evaluating whether an early three-day course of oral dexamethasone can improve recovery and wellbeing in children aged 4 to 17 years with Sydenham's chorea, a movement disorder caused by inflammation in the brain after a Group A streptococcus infection. This condition affects children's movements, mood, and concentration, and can take months to fully recover from. The study is a randomized, double-blinded, placebo-controlled phase 3 trial conducted in New Zealand and Australia, focusing on reducing symptoms and improving mental health outcomes. Participants will be randomly assigned to receive either oral dexamethasone suspension at a dose of 20mg/m2/day (up to 24mg/day) divided into three doses daily for three days, or matching placebo capsules taken three times daily for the same duration. The study compares the effects of this short steroid course against placebo to determine safety and effectiveness in treating Sydenham's chorea. The trial plans to enroll 80 children from multiple hospital sites. During the study, children's chorea severity and psychiatric symptoms will be assessed at one, three, and twelve months using standardized rating scales and questionnaires. Safety checks for adverse events related to dexamethasone will occur on days three, seven, and at one month. Additional outcomes include relapse rates, hospital length of stay, and treatment failures. The total follow-up period spans a year to monitor both physical and mental recovery.