Charleroi

Researchers aim to improve understanding and treatment of brain metastases from solid tumors, which currently have limited systemic treatment options. This study focuses on patients with newly diagnosed non-CNS metastatic solid tumors who are at high risk of developing central nervous system CNS metastases. By gathering detailed clinical and biological information, including analyses of circulating tumor DNA ctDNA from cerebrospinal fluid CSF samples, the study seeks to identify new therapeutic targets and develop innovative treatment strategies. The study is organized into three time periods before the first CNS event Part A, at the first CNS diagnosis Part B, and after the first CNS event Part C. Participants will undergo scheduled collections of plasma, serum, CSF samples, and non-CNS metastatic tumor tissue as applicable, along with brain MRI scans at specific intervals depending on their part in the study. Sample collections and imaging are scheduled annually, every few months, or as clinically indicated, aligned with the participants cancer type and study period. Participants will have regular assessments including imaging and biological sample collections to monitor disease progression and tumor biology. Researchers will analyze the epidemiology and biology of CNS metastases over approximately eight years. Study procedures include lumbar punctures for CSF collection, brain MRIs, and collection of tumor tissue when possible. Participants safety and life expectancy are considered, and follow-up will continue throughout the study duration to support data collection and understanding of CNS metastases.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating the efficacy and safety of fosmanogepix, given either intravenously or orally, for treating adult patients diagnosed with invasive mold infections. This Phase 3 trial compares fosmanogepix to the standard antifungal therapies. The study mainly aims to assess all-cause mortality by Day 42 and includes patients both receiving primary therapy and those receiving salvage treatment after prior therapies failed or were not tolerated. Participants are assigned to one of two cohorts Cohort A, where patients receive either fosmanogepix or the best available standard antifungal treatment, and Cohort B, where patients receive only fosmanogepix as salvage therapy. Fosmanogepix is administered via IV infusion or oral tablets. The treatment phase targets 84 days but can be extended up to 180 days, followed by a follow-up period. During the study, participants undergo various assessments including mortality evaluation at Day 42, clinical and radiological response checks, laboratory tests, neurological exams, ECG monitoring, and plasma drug level measurements at multiple time points. Safety is closely monitored throughout the study and follow-up, which together may last approximately 8 months. Researchers will track adverse events and overall treatment success over this period.

This research is an extension study for participants with cancer who have been previously enrolled in a Genentech andor F. Hoffmann-La Roche sponsored study. It aims to provide continued treatment with Roche investigational medicinal products IMPs either as monotherapy or combined with other agents for those still on study treatment at the time of rollover, particularly when local access to the study treatment is not available. The study is open-label and multicenter, focusing on long-term treatment continuation under medical supervision. Participants will continue receiving Roche IMPs following the same dose, schedule, and administration guidelines as in the parent study. Treatments include monotherapy or combination therapy with drugs such as Ipatasertib, Tiragolumab, Atezolizumab, Bevacizumab, Entrectinib, Inavolisib, and Divarasib. Treatment continues until disease progression, loss of clinical benefit, death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, local treatment availability, or study termination. During the study, participants are monitored for ongoing treatment benefits and adverse events as assessed by standard criteria. Researchers measure the number of participants maintaining access to Roche IMP-based therapy and track the number and severity of selected adverse events over up to approximately 10 years. Safety and treatment effectiveness are evaluated regularly, with participant follow-up continuing as long as treatment is administered or until study completion.

This research aims to evaluate the effectiveness and safety of zanidatamab combined with a physicians choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer who have either progressed on or cannot tolerate previous trastuzumab deruxtecan T-DXd treatment. Zanidatamab has shown promising results against various HER2-positive advanced tumors, including metastatic breast cancer, and may serve as a potential treatment option for these patients. The study also investigates patient-reported tolerability and physical functioning, as well as the pharmacokinetics and immune response to zanidatamab with chemotherapy. Participants will be randomly assigned to receive either zanidatamab or trastuzumab, each given by intravenous infusion alongside one of several chemotherapy options chosen by the physician eribulin, vinorelbine, gemcitabine, or capecitabine the latter is taken orally. Treatment will be administered according to the assigned group, and the study is open-label and multicenter, designed to compare these two treatment combinations in this patient population. During the study, participants will undergo regular assessments to monitor disease progression using imaging criteria RECIST version 1.1, evaluate survival, treatment response, and duration of response. Safety and side effects will be tracked through adverse event reporting and patient questionnaires on symptoms and physical function. Blood samples will be collected to study drug levels and immune reactions. Participants will be followed until disease progression, death, or for up to approximately 44 months for key outcomes, with overall survival monitored for up to about 80 months.

Researchers are evaluating the effectiveness of two chemotherapy combinations, 5-FU with nanoliposomal irinotecan NALIRI and 5-FU with nanoliposomal irinotecan plus oxaliplatin NALIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma PDAC who have progressed after treatment with Gemcitabine-Abraxane or Gemcitabine alone. This phase 2 randomized study aims to assess the progression-free survival rate and safety of these treatments in fit patients with good performance status. Participants receive treatment in 14-day cycles. In the NALIRI group, patients are given leucovorin, nanoliposomal irinotecan at 70 mgm, and 5-FU through intravenous infusion. The NALIRINOX group receives oxaliplatin, leucovorin, nanoliposomal irinotecan at 50 mgm, and 5-FU. The study monitors dosing adjustments based on individual tolerance, especially for patients with specific genetic markers. Treatments are administered mostly via intravenous infusions over several hours and continuous infusions over two days. During the study, participants undergo regular imaging scans, tumor marker tests, and safety assessments to evaluate treatment response and side effects. Researchers track progression-free survival at day 85 post-randomization and continue monitoring survival and disease control for up to five years. Safety is closely followed through laboratory tests, physical exams, and adverse event reporting until two weeks after treatment ends. The total participation time varies depending on individual treatment response and follow-up duration.