Adapazari

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

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.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease CKD and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio UACR to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.

Researchers are evaluating the efficacy and safety of Kedrion Intravenous Immunoglobulin 10% IVIg 10% in adult patients with chronic primary immune thrombocytopenia ITP, a condition characterized by low platelet counts lasting more than 12 months. This phase 3 study aims to assess how well this treatment works and its tolerability in adults aged 18 to 70 years with chronic ITP. Participants will receive one course of Kedrion IVIg 10% at a dose of 2 gkg, administered intravenously over 2 days. This single-group interventional study involves only this treatment, with no placebo or comparator. The treatment is given once, and participants will be followed up to 30 days after administration to monitor response and safety. During the study, participants will undergo platelet count assessments and evaluations for response to treatment, including complete response and time to platelet count improvement. Researchers will also monitor regression of hemorrhages and assess safety and tolerability from the first day of treatment through the end of the 30-day study period. The primary outcome measure is the rate of subjects with a response by day 14 after treatment.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early anti-tumor activity of new drugs or combinations given before and after surgery in adults with locally advanced resectable gastric, gastroesophageal junction GEJ, or esophageal adenocarcinoma who have not had prior treatment for this disease. This Phase II, open-label study includes multiple sub-studies to test different novel drug combinations in participants. Participants will be assigned to one of three sub-studies where they receive combinations of investigational drugs such as AZD0901, Rilvegostomig, Trastuzumab Deruxtecan T-DXd, and chemotherapy agents like 5-Fluorouracil 5-FU, Capecitabine, or FLOT chemotherapy. Treatment is given as neoadjuvant before surgery and adjuvant after surgery therapy, with Rilvegostomig continuing as monotherapy after these phases. Drugs are administered mainly by intravenous infusion, except for Capecitabine, which is given orally. Participants will be closely monitored throughout the study for side effects and response to treatment, including assessments of surgical success, tumor response, event-free survival, and overall survival up to 38 months. Regular evaluations include clinical exams, laboratory tests, and pharmacokinetic measurements to track drug levels and immune response. The study aims to gather comprehensive safety and effectiveness data during the treatment and follow-up periods.

Researchers are investigating whether adding intismeran autogene to pembrolizumab after surgery helps people with non-small cell lung cancer NSCLC stay cancer-free longer compared to pembrolizumab with a placebo. This study focuses on participants whose tumors did not fully respond to treatment before surgery. It is a phase 3 trial aiming to evaluate treatment options for resectable stage II to IIIB N2 NSCLC patients who did not achieve a complete pathological response after neoadjuvant therapy. Participants receive neoadjuvant treatment with pembrolizumab and chemotherapy drugs such as cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel, given by intravenous infusion every three weeks for up to four cycles. After surgery, participants receive adjuvant treatment with pembrolizumab every six weeks combined with either intismeran autogene or placebo by intramuscular injection every three weeks, for up to seven and nine doses respectively. During the study, participants undergo treatment cycles, surgery, and follow-up assessments. Researchers evaluate disease-free survival over approximately 97 months and monitor overall survival, metastasis-free survival, quality of life, physical and role functioning, and adverse events up to around 129 months. The study includes regular evaluations and safety monitoring to understand the impact of these treatments on long-term outcomes and participant well-being.