Suresnes

Researchers are evaluating how well a special imaging scan called 68Ga-FAPI-46 PETCT can predict the response of early-stage high-risk triple-negative breast cancer TNBC to treatment before starting therapy. This study focuses on patients receiving a combination of pembrolizumab, a type of immunotherapy, with chemotherapy as a standard care approach. The study is prospective and involves multiple centers collaborating to understand treatment outcomes better. Patients will receive pembrolizumab at a dose of 200 mg every three weeks alongside 4 cycles of paclitaxel plus carboplatin chemotherapy, followed by 4 cycles of either doxorubicin or epirubicin plus cyclophosphamide. After surgery to remove the tumor, participants will continue with up to 9 cycles of pembrolizumab as adjuvant therapy or until cancer returns or unacceptable side effects occur. Before treatment begins, each patient will have a 68Ga-FAPI-46 PETCT scan performed within 14 days, using the same machine as the standard 18F-FDG PETCT scan. During the study, researchers will collect imaging data and monitor patients throughout the entire treatment and follow-up period. They will assess how well the imaging scan predicts the tumors histological response to therapy by measuring outcomes such as the area under the ROC curve at 6 months. The study will also compare the predictive and prognostic performance of the 68Ga-FAPI-46 PETCT scan against the standard 18F-FDG PETCT scan. Participants will be followed closely for safety and treatment response during the neoadjuvant, surgical, and adjuvant phases of care, with the study ending by November 2032.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are studying new treatment options for people with high-risk non-muscle invasive bladder cancer HR NMIBC, including cases with carcinoma in situ CIS. HR NMIBC affects the lining of the bladder but has not spread to muscle or beyond. The study aims to learn if adding intismeran autogene V940 to the standard Bacillus Calmette-Guerin BCG immunotherapy can improve outcomes by helping the immune system attack the cancer more effectively. Participants are divided into groups receiving different treatments. One group Cohort A receives both intismeran autogene via intramuscular injection every 3 weeks for 9 doses and BCG instillations weekly in specific weeks over about 75 weeks. Another group receives only BCG following the same weekly schedule. A third group Cohort B receives intismeran autogene alone every 3 weeks for 9 doses. The study evaluates these treatments over several years. During the study, participants will have regular treatments and follow-up visits where researchers will monitor cancer progression, recurrence, and survival for up to approximately 5 years. Assessments include event-free survival, recurrence-free survival, overall survival, response rates, time to cystectomy, and safety outcomes such as adverse events and treatment discontinuation. The study is randomized and open-label, with detailed long-term monitoring planned.

Researchers are evaluating the combination of BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in participants with advanced, metastatic, or relapsed small cell lung cancer SCLC and non-small cell lung cancer NSCLC. This multi-part study aims to find safe doses, optimize treatment, assess preliminary effects, and confirm clinical efficacy in different lung cancer groups. The study includes participants with confirmed lung cancer who have measurable disease and meet specific health criteria. Participants will receive intravenous infusions of BNT324 combined with BNT327 in a dose escalation design to establish two recommended dose levels RP2D and RP2D-1. The study has two parts Part 1 focuses on dose finding in NSCLC and SCLC Part 2 compares these doses in treatment-naive and relapsed lung cancer cohorts, with some randomized groups. Additional participants may join at the optimal dose to further evaluate safety and effectiveness. Participants will undergo screening, followed by treatment, safety follow-up, and long-term survival monitoring. Researchers will assess dose-limiting toxicities, adverse events, treatment interruptions, and response rates using standardized criteria. Outcomes include objective response rate, disease control, progression-free survival, duration of response, and overall survival, with evaluations continuing up to 87 months. Safety is closely monitored during and after treatment, and participants health status is regularly assessed.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

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 studying patients with completely removed non-small cell lung cancer NSCLC who have common mutations in the EGFR gene, specifically Del19 or L858R. The study aims to use broad-panel centralized next-generation sequencing NGS testing at the start to better understand molecular factors that predict outcomes and to investigate mechanisms of resistance to the drug osimertinib after treatment. This research focuses on patients with stage pIB to IIIA NSCLC who have undergone thorough preoperative assessments and quality surgical excision reviews. Participants will have plasma circulating tumor DNA ctDNA tested at various stages before surgery optional, 4 to 8 weeks after surgery, before starting adjuvant chemotherapy or osimertinib if given, every 6 months during follow-up, and at relapse if it occurs. Formalin-fixed paraffin-embedded FFPE tissue blocks from surgery and relapse optional will also be collected for molecular analyses. Treatment with osimertinib as adjuvant therapy is planned for up to 3 years, with chemotherapy given beforehand if needed. During the study, patients will be regularly followed every 3 to 6 months with standard care visits and molecular testing. Researchers will monitor the feasibility of the testing approach over 18 months and track the incidence and severity of any side effects related to osimertinib for about 3 years. This ongoing monitoring aims to better understand relapse mechanisms and improve treatment options in metastatic relapse. The total participation duration aligns with the follow-up and safety monitoring periods outlined.

Researchers are evaluating the effects of extracorporeal photopheresis ECP therapy in patients who have undergone lung transplantation and have subclinical antibody-mediated rejection with persistent donor-specific antibodies dnDSAs. The study aims to determine whether ECP can reduce the mean fluorescence intensity MFI of these antibodies, and assess its impact on acute cellular rejection ACR, clinical antibody-mediated rejection AMR, chronic lung allograft dysfunction CLAD, infections, survival, adverse events, and other immunological markers. The trial will randomly assign 80 patients into two groups of 40 each. One group will receive ECP treatment starting within one week after randomization, consisting of two-day treatment cycles every two weeks for the first two months, followed by monthly two-day cycles for six months. The control group will be observed without receiving active treatment, representing the current standard of care. Researchers will compare outcomes between the groups, including immunophenotyping, miRNA profiling, cytokine expression, gene expression of peripheral blood mononuclear cells, and proteomic analysis. Participants will be monitored over six months to evaluate changes in dnDSA levels and clinical outcomes such as rejection episodes, infections, survival, and adverse effects. Assessments will include laboratory tests and immunological profiling to understand the mechanisms of ECP. This study is sponsored by the Medical University of Vienna and involves patients who are clinically stable with persistent dnDSAs and no signs of graft dysfunction after bilateral lung transplantation.