Charleroi

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread from the cervix to other parts of the body. This Phase 3 study aims to evaluate the safety and effectiveness of combining sacituzumab tirumotecan (sac-TMT), an antibody drug that targets cancer cells, with pembrolizumab and bevacizumab. The study seeks to find out if this combination can help people live longer or keep their cancer from worsening compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT together with pembrolizumab and bevacizumab to assess safety. In Part 2, after standard initial treatment, those whose cancer does not progress will be randomly assigned to maintenance treatment with either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may be added during maintenance treatment based on the doctor's decision. All treatments are given through intravenous infusions, and participants may receive rescue medications to manage side effects before sac-TMT infusion. Participants will be monitored for adverse events and treatment tolerability over several months. The study measures include progression-free survival and overall survival, assessed by independent review. Safety and treatment continuation rates are tracked during Part 1 for up to approximately 66-69 months, while Part 2 outcome measures extend up to 48-60 months. Various assessments, including laboratory tests and evaluations of cancer status, will be performed throughout the study to understand treatment effects and participant well-being.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness of fosmanogepix, given either intravenously or orally, for treating adults diagnosed with invasive mold infections. This Phase 3 study focuses on patients infected with molds such as Aspergillus species, Fusarium species, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant molds. The main goal is to compare the overall death rate at 42 days against a fixed threshold to assess treatment outcomes. Participants will be assigned to one of two groups: Cohort A includes patients receiving either the study drug fosmanogepix or the standard antifungal treatment based on institutional practice, while Cohort B includes patients receiving fosmanogepix as a salvage treatment after not responding to or not tolerating prior therapies. Fosmanogepix is administered through intravenous infusion or oral tablets. The study treatment period targets 84 days but can be extended up to 180 days depending on patient needs. Throughout the study, lasting up to approximately 8 months including follow-up, participants will undergo evaluations to monitor their response, safety, and overall health status. Researchers will track the all-cause mortality rate by Day 42 as the primary outcome. Safety and treatment effects will be assessed regularly during treatment and follow-up to ensure participant well-being and gather comprehensive data on fosmanogepix’s impact.

This research focuses on participants with cancer who were previously enrolled in Genentech and/or F. Hoffmann-La Roche sponsored studies. It aims to provide continued treatment with Roche investigational medicinal products (IMPs) or comparator agents for those who are still receiving study treatment at the time they transition from the parent study and lack access to the treatment locally. The study is an open-label, multicenter phase 3 extension trial designed to offer ongoing therapy for eligible participants. Participants will continue receiving the same Roche IMPs or comparator agents at the doses, schedules, and administration methods that were in effect at the time they stopped treatment in the parent study. Treatments include drugs like Ipatasertib, Tiragolumab combined with Atezolizumab, Atezolizumab alone or in combination, Bevacizumab alone or with Atezolizumab, Entrectinib, Inavolisib, and Divarasib with or without other agents. The first dose in this extension study must be given within 7 days of the allowed treatment interruption from the parent study. During the study, researchers will monitor participants for continued access to the study treatments and track any adverse events using standard criteria for up to about 10 years. Participants must comply with study protocols and will be regularly assessed for safety and ongoing benefit from the treatment. This long-term follow-up is designed to gather data on treatment continuation, safety, and tolerability over an extended period.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the effectiveness and safety of zanidatamab combined with a physician's choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer. This study focuses on participants whose cancer has progressed or who cannot tolerate previous treatment with trastuzumab deruxtecan (T-DXd). The study is a phase 3 randomized trial aiming to assess progression-free survival and other important outcomes such as patient-reported tolerability and physical functioning. Participants receive either zanidatamab or trastuzumab through intravenous infusion, alongside chemotherapy drugs chosen by their physician from eribulin, gemcitabine, vinorelbine (all intravenous), or oral capecitabine. The study includes detailed monitoring of drug safety and how the body processes zanidatamab. The treatments continue until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including scans to measure cancer progression according to RECIST guidelines. Researchers also monitor safety through laboratory tests and heart function assessments. Participants are followed for up to approximately 44 months to measure progression-free survival and overall treatment outcomes. Long-term follow-up and patient-reported outcomes help provide a complete understanding of the treatments' effects.

Researchers are evaluating the effectiveness of two treatment combinations, 5-FU with nanoliposomal irinotecan (NALIRI) and 5-FU with nanoliposomal irinotecan plus oxaliplatin (NALIRINOX), for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) that has progressed after initial gemcitabine-based therapies. This phase 2 randomized study focuses on patients who are physically fit with good performance status (ECOG 0-1). The main goal is to measure how long patients live without disease progression after starting these treatments. Participants will be randomly assigned to one of two groups. The control group receives NALIRI with 5-FU and leucovorin, while the investigational group receives NALIRINOX, which adds oxaliplatin to the same combination. Dosing varies between groups: NALIRI is given at 70 mg/m² with 2400 mg/m² of 5-FU and 400 mg/m² of leucovorin, while NALIRINOX includes 50 mg/m² of nanoliposomal irinotecan, 2400 mg/m² of 5-FU, 400 mg/m² of leucovorin, and 60 mg/m² of oxaliplatin. The study assesses safety, side effects, tumor response via imaging and tumor markers, and overall survival alongside progression-free survival. During the study, participants will undergo regular assessments including imaging scans to evaluate tumor size and response, blood tests to monitor safety and tumor markers, and evaluations of side effects using standard criteria. Researchers will track progression-free survival at day 85 from randomization as the primary outcome. The study also monitors overall survival and treatment tolerability. Participants must be monitored for safety throughout, with follow-up visits to assess long-term outcomes and treatment effects.