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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating whether accelerated BEP chemotherapy is more effective than the standard BEP regimen for males aged 11 to 50 years with intermediate and poor-risk metastatic germ cell tumors. This phase 3 randomized trial aims to improve cure rates for these patients, as current treatments have limited success for higher-risk disease. The study is led by the University of Sydney and focuses on first-line chemotherapy outcomes for metastatic germ cell tumors. The study compares two treatment schedules standard BEP chemotherapy given every 3 weeks for 4 cycles, and accelerated BEP given every 2 weeks for 4 cycles followed by additional bleomycin doses. Both regimens include bleomycin, etoposide, cisplatin, and supportive growth factors like pegylated G-CSF or filgrastim, with dosing adjusted by age and weight. Treatment lasts about 12 weeks in both arms. Participants will undergo treatment cycles with regular intravenous chemotherapy infusions and weekly bleomycin doses. Researchers will assess progression-free survival up to 5 years after randomization, along with tumor response at the end of treatment and at 6 months. Safety will be monitored through adverse events, and quality of life will be measured up to 18 months. Overall survival and chemotherapy dose intensity are also tracked. The study involves multiple assessments and follow-up visits to monitor effects and outcomes.

Age: 11Years - 50YearsAll GendersPhase 3
28 locations
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Actively Recruiting

This research aims to assess the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with rilvegostomig or rilvegostomig alone compared to pembrolizumab alone as initial treatment in participants with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has high PD-L1 expression tumor cells 50% and no actionable genetic alterations. This Phase III, randomized, open-label global study focuses on patients who have not received previous systemic therapy for advanced disease. Participants are randomly assigned to one of three groups one group receives Dato-DXd plus rilvegostomig, another receives rilvegostomig alone, and the third receives pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study evaluates these treatments as first-line therapy for eligible participants. During the study, participants will have regular assessments including tumor evaluations and biomarker testing to monitor disease progression, overall survival, and response rates. Patient-reported symptoms and quality of life will also be measured. The study may last up to approximately six years to capture long-term outcomes. Safety monitoring and pharmacokinetics assessments are included throughout the trial to understand treatment effects and immune responses.

Age: 18Years +All GendersPhase 3
287 locations