Tekirdag Merkez

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness, safety, and tolerability of mavorixafor in people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These participants experience repeated and/or serious infections due to low neutrophil levels. The study aims to show clinical benefit by increasing circulating neutrophils and reducing infection rates. Participants will continue their existing treatments, which may include granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement, prophylactic antibiotics, or observation without active treatment. They will be randomly assigned to receive either mavorixafor or a placebo, with both drugs given according to a set schedule. The study is double-blind and placebo-controlled, conducted across multiple centers. During the study, researchers will monitor participants for up to 52 weeks, focusing on the annual infection rate and the number of participants achieving a positive response in absolute neutrophil count. Participants will undergo regular assessments, including blood tests to measure neutrophil levels and evaluations for infections. The study includes safety monitoring and requires participants to maintain stable doses of their background therapies unless safety concerns arise.

Researchers are evaluating the safety, tolerability, and effectiveness of nemtabrutinib combined with venetoclax compared to venetoclax plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one prior therapy. This Phase 3, open-label study aims to confirm the dose of nemtabrutinib in this combination and test the hypothesis that adding nemtabrutinib improves progression-free survival based on 2018 iwCLL criteria assessed by blinded independent central review. Participants receive treatment with tablets of nemtabrutinib (5, 20, 45, or 65 mg) and venetoclax (10, 50, or 100 mg) or with venetoclax plus intravenous rituximab infusions (100 mg/10 mL and 500 mg/50 mL doses). The study compares these two regimens to assess efficacy and safety. The treatment period lasts up to approximately 71 months for progression-free survival evaluation, with earlier assessments of dose-limiting toxicities within 12 weeks and adverse events monitored up to around 28 months. During the study, participants undergo evaluations of safety including adverse events and treatment tolerability, with monitoring for discontinuation due to side effects. Disease progression is assessed using iwCLL criteria by a blinded central review. Participants must have confirmed active disease and meet specific health and organ function requirements before starting treatment. The study includes long-term follow-up to measure progression-free survival and overall safety over several years.

Researchers are conducting a global Phase 3 study to compare the effectiveness and safety of olverembatinib combined with chemotherapy versus the investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in patients newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). This study aims to evaluate these treatments in a randomized and open-label setting to determine the best approach for this condition. Participants will receive treatment in one of two groups: one group will take olverembatinib orally every other day along with chemotherapy, while the other group will receive an investigator-chosen TKI orally once daily combined with chemotherapy. Both treatments are studied over cycles of 28 days, focusing on the initial three cycles for measuring response. During the study, participants will be monitored for treatment effects, including the rate of minimal residual disease negative complete remission from cycles 1 to 3. Researchers will assess safety, treatment adherence, and any side effects. The study includes various evaluations to ensure participant health and treatment effectiveness over the course of therapy.

Researchers are evaluating whether adding intismeran autogene to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) remain cancer-free longer compared to pembrolizumab with a placebo. This study focuses on patients with NSCLC whose tumors did not completely respond to treatment before surgery and aims to prevent the cancer from returning. It is a Phase 3 randomized, double-blind study involving participants with resectable Stage II to IIIB (N2) NSCLC. Participants receive treatments including pembrolizumab given as an intravenous infusion and either intismeran autogene or placebo administered as an intramuscular injection. Before surgery, patients have received neoadjuvant pembrolizumab combined with platinum-based doublet chemotherapy, but only those who did not achieve a complete pathological response are eligible. The study compares the effects of pembrolizumab with or without intismeran autogene following surgery. During the study, participants are closely monitored for disease-free survival over a period of up to approximately 97 months. Researchers will assess whether the cancer returns and evaluate overall safety. Participants undergo regular evaluations including clinical assessments and laboratory tests to monitor their health and treatment response throughout the study period.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. This Phase 3 study aims to assess the safety, tolerability, and effectiveness of odronextamab alone and compared to the current standard treatments, including rituximab combined with different types of chemotherapy. The study also examines side effects, drug levels in the blood, antibody responses against odronextamab, and the impact on quality of life and daily activities. The study consists of two parts: Part 1 is non-randomized and focuses on the safety and tolerability of odronextamab given alone. Part 2 is randomized and controlled, comparing odronextamab to rituximab combined with chemotherapy regimens such as CHOP, CVP, or Bendamustine-containing therapies. All treatments are administered according to the study protocol. Participants receive these treatments to evaluate how well odronextamab works versus standard care. Participants will undergo various assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor bone marrow and liver function, and evaluations of side effects up to two years. Researchers will track dose-limiting toxicities within 35 days and assess complete response rates over 30 months. Safety and side effects will be monitored continuously, and quality of life will also be evaluated. The total length of participation depends on treatment and follow-up schedules defined in the protocol.

Researchers are evaluating two surgical methods for treating complex Peyronie's disease, a condition where fibrous plaques in the penile tunica albuginea cause curvature and deformities that interfere with sexual intercourse. The study aims to compare subtunical microdissection, a newer technique that carefully dissects beneath the plaque to preserve erectile tissue, with the classical plaque incision and grafting method, which involves cutting the plaque and placing a graft. The purpose is to see if the subtunical microdissection can effectively correct curvature while better preserving erectile function. Participants with severe deformities such as multiplanar curvature, hinge effect, or hourglass deformity will undergo one of the two surgical procedures. Both surgeries use the same bovine pericardial graft material sized by geometric principles to repair the tunical defect. The subtunical microdissection uses microsurgical instruments under 3.5× magnification to carefully release the plaque, while the classical method involves direct plaque incision before graft placement. All surgeries are performed by the same team with a uniform anesthesia protocol to keep procedures consistent. After surgery, patients will be followed to assess penile straightening, erectile function, patient satisfaction, penile length changes, and any complications or need for further procedures. The main outcomes measured at six months include the degree of curvature correction and erectile function compared to baseline. This follow-up helps determine which surgical approach offers effective correction with the best functional results and safety for men with complex Peyronie's disease.