Whittier

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are studying the long-term risk of liver failure linked to TURALIO14 pexidartinib treatment in patients with symptomatic tenosynovial giant cell tumor TGCT who have severe symptoms or functional problems and cannot improve with surgery. This study also explores how liver damage happens by examining liver biopsy samples from patients who have or had liver toxicity while on TURALIO14. The goal is to understand liver injury mechanisms and assess safety over time. This is a non-interventional, observational study where no study medication is given. Participants have experienced liver test abnormalities from TURALIO14 treatment. Optional liver biopsies will be taken for detailed analysis of immune cells in the liver. Blood samples will also be collected to monitor liver function, safety, immune cells, and genetics. Participants will be followed yearly for up to 10 years to track liver health and potential failure after stopping TURALIO14. During the study, participants will provide blood samples and may choose to have a liver biopsy for further testing. Researchers will assess liver test results and monitor for signs of liver failure, liver transplant need, or death. Follow-up visits occur at least once per year for 10 years to observe long-term effects. The main outcome measured is how often liver failure occurs after stopping TURALIO14, helping to better understand long-term safety in this group.

This research aims to provide continued access to niraparib and to further assess its long-term safety in participants with ovarian or breast neoplasms who are currently receiving niraparib treatment within previous GlaxoSmithKlineTESARO-sponsored studies. It focuses on participants who have completed earlier studies where the primary objectives were met and are judged by their doctors to still benefit from niraparib. The study is a phase 2, open-label extension trial designed to monitor treatment continuation and safety over time. Participants will receive niraparib once daily by mouth, following the same dose and schedule as in their previous parent study. Treatment is organized in 90-day cycles and will continue until disease progression, unacceptable side effects, new anticancer therapy unrelated to the parent study, withdrawal, or other reasons for discontinuation occur. The dosing regimen mirrors what was assigned in the prior study, ensuring consistency for each participant. During the study, participants will have regular evaluations to monitor safety and health status for up to five years. These assessments include tracking adverse events, serious side effects, and specific safety concerns, as well as monitoring physical exams, vital signs, blood tests, and medication use. Participants must comply with scheduled visits and treatments while using effective contraception if of childbearing potential. The study duration and follow-up are designed to gather detailed long-term safety information on niraparib treatment.

Researchers are evaluating the effectiveness of combining tarlatamab with durvalumab, carboplatin, and etoposide compared to the combination of durvalumab, carboplatin, and etoposide alone in treating patients with untreated extensive stage small-cell lung cancer ES-SCLC. The main goal is to see if the addition of tarlatamab can help patients live longer overall. This is a phase 3, open-label, randomized study conducted across multiple centers. Participants are assigned to one of two groups. One group receives tarlatamab combined with durvalumab, carboplatin, and etoposide for four treatment cycles, followed by maintenance treatment with tarlatamab and durvalumab. The other group receives durvalumab, carboplatin, and etoposide for four cycles, followed by durvalumab alone. All drugs are given as intravenous infusions. The study lasts up to approximately 3.5 to 4 years to assess survival and disease progression. During the study, participants will undergo regular assessments including evaluations of overall survival and progression-free survival. Other measures include response to treatment, disease control, duration of response, and monitoring for treatment-related adverse events. Blood tests will evaluate drug levels and antibody development. The research team will carefully monitor participants throughout the treatment and follow-up periods, keeping track of their health and any side effects.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating the efficacy and safety of BGB-16673 compared with the investigators choice of treatments in participants with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with both Bruton Tyrosine Kinase inhibitors BTKi and B-cell leukemialymphoma 2 protein inhibitors BCL2i. This study addresses the urgent need for new treatments to extend life and control symptoms such as enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever in these patients. Participants will be randomly assigned to receive either BGB-16673 once daily or the investigators choice of treatment, which includes idelalisib plus rituximab for CLL only, bendamustine plus rituximab, or venetoclax plus rituximab retreatment. Treatments will continue until criteria for stopping treatment are met. This is a Phase 3, open-label, randomized study conducted globally with about 250 participants. During the study, participants will undergo regular assessments to monitor disease progression and response to treatment. Researchers will evaluate progression-free survival, overall survival, response rates, duration of response, and quality of life measures over approximately 24 to 36 months. Safety will be closely monitored by tracking treatment-emergent adverse events. Participants involvement includes receiving study medication, regular visits, and various evaluations to assess treatment effects and side effects.

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.

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin ZV combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma rrDLBCL. This Phase 23 study is divided into two parts Dose Confirmation and Efficacy Expansion. It aims to compare ZV combined with rituximab, gemcitabine, and oxaliplatin R-GemOx against R-GemOx alone, and ZV combined with bendamustine rituximab BR against BR alone, focusing on progression-free survival. Enrollment in the BR-related arms has been discontinued with no analysis planned for those arms.