Spokane Valley

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

This trial evaluates the safety and treatment effects of palopegteriparatide at doses above 30 mcgday in adults with hypoparathyroidism. It focuses on adults already receiving palopegteriparatide at doses of 30 mcgday or higher, aiming to provide more evidence about treatment impact and safety. The study is conducted in the United States and is a Phase 3 randomized clinical trial. Participants receive daily subcutaneous injections of palopegteriparatide, with dosing individually adjusted through either a novel or previously tested titration algorithm. All participants receive the active drug during the 78-week treatment period. The trial compares two dosing algorithms to find an optimal dose for each participant. Throughout the study, participants are monitored for efficacy primarily at 26 weeks and continue treatment for a total of 78 weeks. Assessments include laboratory tests to confirm vitamin D, magnesium, and calcium levels, as well as safety and tolerability evaluations. The trial aims to understand how well the drug works and its safety profile over this extended period.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Researchers are evaluating dapirolizumab pegol DZP as an add-on treatment to standard care medications for people with moderate to severe active systemic lupus erythematosus SLE. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess whether DZP can achieve meaningful long-term improvement in disease activity compared to placebo. Participants must have been diagnosed with SLE at least 24 weeks prior and meet specific disease activity and serological criteria. Participants will be randomly assigned to receive either dapirolizumab pegol or placebo throughout the treatment period. Both groups will continue their stable standard of care medications, which may include antimalarials, glucocorticoids, andor immunosuppressants. The study is designed with a parallel group structure and masking to ensure unbiased assessment of efficacy and safety over a treatment period extending up to 48 weeks. During the study, participants will be monitored regularly to assess disease activity using tools such as the British Isles Lupus Assessment Group Disease Activity Index 2004 BILAG 2004 and Systemic Lupus Erythematosus Disease Activity Index 2000 SLEDAI-2K. Researchers will track responses at Week 48 and evaluate additional outcomes like flare prevention, fatigue levels, glucocorticoid dose reduction, and safety events. Follow-up will continue up to Week 54 to monitor adverse events, ensuring comprehensive evaluation of participant health and treatment effects.

Researchers are evaluating the effectiveness of adding tirzepatide to ongoing ixekizumab therapy in adults with active psoriatic arthritis PsA who are overweight or obese and have at least one weight-related health condition. This Phase 4 study aims to assess how well this combination works in real-world clinical practice over a 12-month period. Participants will continue their current ixekizumab treatment and begin taking tirzepatide, which is administered by subcutaneous injection as directed by the medication label. The study involves a single treatment group where all participants receive this combination therapy, with treatment lasting up to 12 months. During the study, participants will be monitored regularly to assess joint symptoms, skin involvement, disease activity, pain, fatigue, physical and mental health, and weight changes. Researchers will collect data at multiple time points, including baseline, 6 months, and 12 months, using questionnaires, joint counts, and physical assessments. The primary outcomes focus on improvements in disability and weight loss after 12 months of therapy.

This trial investigates monitoring and treatment options for patients with low risk and standard risk metastatic germ cell tumors, which are cancers that start in the cells that produce sperm or eggs. The study aims to find out if active surveillance after surgical removal of low risk tumors can maintain high survival rates, and whether carboplatin or cisplatin chemotherapy works better for treating standard risk tumors in children, adolescents, and young adults. Patients with low risk tumors undergo observation after surgery and may transfer to a standard risk treatment arm if the tumor recurs. Those with standard risk tumors are randomly assigned to receive one of two chemotherapy regimens one containing carboplatin, bleomycin, and etoposide, or the other containing cisplatin, bleomycin, and etoposide. Treatments are given intravenously in cycles every 21 days for up to 3 or 4 cycles depending on the group. Throughout the study, patients have imaging scans, blood tests, tumor biopsies, and pulmonary function tests to monitor response and side effects. Participants are followed closely during treatment and afterward with regular check-ups including CT, MRI, and chest X-rays, as well as blood sample collections. Follow-up visits occur every 2 months for the first year, then every 3-6 months up to 2 years, every 6 months for years 3 to 5, and annually up to 10 years. Researchers measure overall survival, event-free survival, hearing loss, body composition, tumor markers, and patient-reported outcomes related to hearing and neuropathy. This long-term monitoring helps assess the effects and safety of chemotherapy and surveillance strategies.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are studying breast cancer patients to find any remaining cancer cells, called minimal residual disease MRD, after their main treatment. Detecting these cells is important because even a small number can cause cancer to return later. This research looks at tiny pieces of cancer DNA in the blood, known as circulating tumor DNA ctDNA, to see if it can predict cancer recurrence and show if treatment is working. The study is observational and aims to help improve breast cancer management and develop better tests and treatments. Participants are grouped into three cohorts those receiving neoadjuvant therapy before surgery, those receiving adjuvant therapy after surgery, and those who have had no evidence of disease for at least five years after diagnosis. There are no interventions or treatments given as part of this study. Instead, the research involves regular blood tests to monitor ctDNA levels over time among these groups to understand cancer behavior and treatment effects. During the study, participants provide blood samples and biospecimens at several time points. Researchers track invasive disease-free survival and overall survival over five years, stratified by MRD status at different stages of treatment and follow-up. They also assess distant disease-free survival, pathologic complete response or residual cancer burden, and the time from first positive MRD detection to cancer recurrence. The study may last up to eight years, including long-term follow-up to monitor outcomes and better understand the role of ctDNA in breast cancer care.

Researchers are studying patients with non-small cell lung cancer NSCLC to better understand how the cancer changes on a molecular level during standard treatments. The study aims to track the diseases progress and explore how changes in circulating tumor DNA ctDNA might predict cancer recurrence and treatment outcomes. This observational study collects clinical and molecular health data over time from patients receiving usual care. The study involves two groups of patients. The first group includes patients with early-stage NSCLC Stages I to IIIB who are treated with surgery and possibly additional therapies before or after surgery. The second group includes patients with advanced stage IV NSCLC receiving first-line immunotherapy, either alone or combined with chemotherapy. Patients will provide blood samples regularly during their routine care to help researchers analyze ctDNA and its changes over time. Participants will be asked to provide tumor samples and give additional blood samples during standard surveillance visits. Researchers will monitor disease-free survival and overall survival over periods up to five years. They will also compare ctDNA testing results with traditional imaging methods used every six months to detect cancer recurrence. The study tracks various outcomes, including treatment patterns and progression-free survival, to gain a detailed understanding of how the disease evolves under standard care.