Suresnes

Researchers are evaluating how well pre-treatment 68Ga-FAPI-46 PET/CT imaging can predict the histological response to neoadjuvant chemo-immunotherapy in patients with early-stage high-risk triple-negative breast cancer (TNBC). This prospective multicenter study focuses on female patients who have not yet been treated and are recommended to receive pembrolizumab combined with chemotherapy as their standard care. The study aims to improve understanding of treatment effectiveness using advanced imaging techniques before therapy begins. Participants will receive neoadjuvant treatment consisting of pembrolizumab 200 mg every three weeks combined first with four cycles of paclitaxel plus carboplatin, followed by four cycles of doxorubicin or epirubicin plus cyclophosphamide. After surgery, patients will continue adjuvant pembrolizumab for nine cycles or until cancer recurrence or unacceptable side effects occur. Each participant will undergo a 68Ga-FAPI-46 PET/CT scan before starting treatment, performed on the same machine as the 18F-FDG PET/CT scan and within 14 days prior to therapy. Throughout the study, researchers will monitor participants using scans and tissue analysis to assess histological response to treatment. They will measure the prediction accuracy through the area under the ROC curve at six months. Patient compliance, informed consent, and health insurance coverage are required for participation. Safety and treatment response will be carefully followed during and after the therapy period.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

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%).

Researchers are studying patients with completely removed non-small cell lung cancer (NSCLC) who have common EGFR mutations (L858R and Del19). The study aims to include broad-panel centralized genetic testing at the start to better understand factors predicting outcomes and resistance to the drug osimertinib when used after surgery. It also investigates the molecular changes linked to cancer returning during or after osimertinib treatment to find better treatment options if the cancer comes back in a metastatic form. The study involves collecting plasma circulating tumor DNA (ctDNA) samples before surgery (optional), 4 to 8 weeks after surgery, before starting any adjuvant chemotherapy or osimertinib treatment, every six months during follow-up, and at relapse. Tumor tissue samples from surgery and optionally at relapse are also collected for molecular analysis. Patients may receive adjuvant chemotherapy if needed before starting osimertinib, which is given with the intent to treat for three years. Participants will be regularly followed every 3 to 6 months according to standard recommendations. Researchers will monitor genetic markers using blood and tissue samples to study cancer relapse and resistance. The main outcome is to assess the feasibility of this molecular monitoring approach over an 18-month period. Safety and long-term follow-up are included, aiming to improve treatment decisions for patients with resected NSCLC and EGFR mutations.

This trial studies patients who have undergone bilateral lung transplantation and have persistent donor-specific antibodies (dnDSAs) without signs of graft dysfunction. It evaluates the effects of extracorporeal photopheresis (ECP), a procedure being studied as a potential treatment to reduce antibody levels and modulate immune response after lung transplant. The trial aims to see if ECP can decrease the mean fluorescence intensity (MFI) of dnDSAs and impact outcomes like antibody-mediated rejection (AMR), acute cellular rejection (ACR), chronic lung allograft dysfunction (CLAD), infections, survival, and adverse events. Participants will be randomly assigned to either a treatment group receiving ECP or a control group under observation without active treatment. The ECP treatment starts within a week of randomization and consists of a two-day cycle every two weeks for the first two months, followed by a two-day cycle once a month for six months. Researchers will also study immune system changes through tests including immunophenotyping, gene expression profiling, cytokine levels, and protein analysis. Throughout the study, participants will be monitored for changes in antibody levels and clinical outcomes related to lung transplant rejection and complications. Safety and side effects will be tracked, alongside detailed immune system evaluations. The study includes 80 patients, each followed for at least six months of treatment, to assess the impact of ECP on immune tolerance and graft health.

Researchers are investigating the effects of delaying radiotherapy in patients with low-grade oligodendrogliomas that have 1p/19q codeletion and IDH mutation. These patients often live a long time but risk cognitive decline when treated with immediate radiotherapy plus PCV chemotherapy. The study aims to see if postponing radiotherapy until tumor progression reduces neurocognitive deterioration without affecting overall survival, in a phase 3 randomized trial. Participants will be assigned to one of two treatment groups: one group will receive six cycles of PCV chemotherapy alone, while the other group will receive radiotherapy delivering 50.4 Gy in 28 fractions using IMRT followed by six cycles of PCV chemotherapy. Each cycle of PCV includes oral CCNU on day 1, intravenous vincristine on days 8 and 29, and oral procarbazine from days 8 to 21. Treatments will be carefully administered and monitored throughout the study. During the study, participants will undergo neurocognitive assessments and quality of life evaluations to monitor changes over time. Researchers will measure survival without neurocognitive deterioration over a nine-year period. Laboratory tests, imaging studies, and clinical examinations will be performed as needed to assess safety and disease progression. The study will also track adherence to treatment and follow participants long term to evaluate outcomes and side effects.