Yuregir

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial 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 evaluating the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are evaluating an investigational drug called marlotamig (REGN7075) alone and in combination with cemiplimab, with or without chemotherapy, in adults with advanced solid tumors. The study aims to assess the safety, tolerability, and optimal dosing of marlotamig with cemiplimab, as well as to explore their effectiveness in treating cancer by controlling tumor growth. Additional goals include monitoring side effects, studying how the drugs work in the body, measuring drug levels in the blood, and checking for the development of antibodies against the treatments that might affect their action or cause side effects. Participants may receive marlotamig through intravenous or subcutaneous injection weekly or every three weeks. Cemiplimab is given every three weeks by intravenous infusion or subcutaneous injection, sometimes combined with platinum-based doublet chemotherapy administered intravenously every three weeks. Other drugs like bevacizumab or trifluridine-tipiracil may also be given according to the study plan. Treatment and dosing schedules are carefully followed to find the best approach to manage advanced cancers. During the study, participants will be closely monitored for adverse effects including dose-limiting toxicities, treatment-emergent adverse events, serious events, and laboratory abnormalities for up to five years after the last dose. Researchers will also measure the objective response rate to evaluate how well tumors respond to treatment. Participants undergo regular assessments including biopsies, blood tests, and clinical evaluations to track safety and effectiveness throughout the study and follow-up periods.

Researchers are evaluating the effectiveness and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wild-type gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with HIF-2α related genetic changes. This phase 2 study aims primarily to measure the objective response rate (ORR) of belzutifan using standardized tumor response criteria reviewed independently and blindly. Participants receive belzutifan orally at a dose of 120 mg once daily until their disease progresses or they stop treatment for other reasons. The study includes a specific cohort for VHL disease-associated tumors, which requires participants to be at least 18 years old. The treatment period continues as long as the participant benefits or tolerates the medication. Throughout the study, participants will be regularly assessed by independent central review to measure tumor response. The study monitors safety and efficacy outcomes for up to approximately 5.5 years. Participants are expected to have a life expectancy of at least 3 months and will be observed carefully for any treatment effects or adverse events during this time.

Researchers are evaluating the effectiveness of brenetafusp (IMC-F106C) combined with nivolumab compared to standard nivolumab treatments in people who have advanced melanoma that has not been treated before. This study focuses on participants who have a specific genetic marker called HLA-A*02:01 and aims to understand how these treatments affect the progression of their cancer. The study is a phase 3, randomized, controlled trial, which helps ensure reliable comparison between the different treatment regimens. Participants in this study will receive either brenetafusp plus nivolumab or standard nivolumab regimens, which may include nivolumab alone or in combination with relatlimab. These treatments are given by intravenous infusion, with specific dosing of the drugs as concentrates for infusion. The study compares these approaches to see which is more effective in controlling the melanoma. During the study, participants will be closely monitored for disease progression and overall health. Researchers will use scans and other assessments to measure progression-free survival, which is the time participants live without their disease worsening, followed for up to about 45 months. Safety and response to treatment will be regularly evaluated to better understand the effects of the therapies over time.