Candiolo

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating MK-1045, an immunotherapy, in people with two types of non-Hodgkin lymphoma NHL follicular lymphoma FL, which grows slowly, and diffuse large B-cell lymphoma DLBCL, which grows more quickly. NHL is a cancer of the lymphatic system causing swollen lymph nodes. This study aims to assess the safety and tolerability of MK-1045 and to see if it can shrink or eliminate these lymphomas. Participants are randomly assigned to one of four groups receiving different doses or methods of MK-1045 administration. Dosages A, B, and D are given by intravenous IV infusion, while Dosage C is given by subcutaneous SC injection. Treatment lasts for up to approximately one year or until participants stop treatment for any reason. During the study, participants will be monitored for adverse events and treatment side effects, with measurements including tumor response using specific criteria. Blood levels of MK-1045 will also be tracked. The study involves regular visits for infusions and assessments. Participant safety and treatment effects will be followed for up to about 49 months in total.

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 evaluating the impact of pelabresib on the pharmacokinetics of repaglinide, midazolam, and combined oral contraceptives containing drospirenone and ethinyl estradiol in adults with advanced malignancies who have no standard or curative treatment options. This Phase 1b study is designed to understand drug-drug interactions and assess continued treatment benefits in participants with these conditions. The study has two parts In Part 1, participants receive pelabresib 225 mg orally once daily for 14 days followed by a 7-day break. Arm A assesses interactions with single doses of repaglinide and midazolam, involving two hospital stays Arm B evaluates interactions with combined drospirenone and ethinyl estradiol, with hospital stays lasting from 2 to 10 nights. Part 2 allows participants who show clinical benefit to continue pelabresib treatment in additional cycles until study end or discontinuation criteria are met. Participants undergo screening before enrollment and receive assigned doses through an interactive response system. Assessments include plasma concentration measurements and pharmacokinetic profiles of the drugs at specific time points during 21-day cycles. Safety monitoring includes adverse event tracking up to 30 days after treatment ends, and participants with hematological malignancies have follow-up every 3 months for leukemic transformation until study completion or other defined endpoints. Total participation includes screening, treatment, follow-up, and monitoring phases.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating a personalized, stage-related, multimodal treatment approach for patients with rectal adenocarcinoma. The study focuses on organ preservation, especially in early-stage tumors, and prioritizes minimally invasive techniques like laparoscopic and robotic surgery to reduce the physical and psychological impact on patients. This phase II, single-center, interventional study aims to improve quality of life while managing rectal cancer effectively. Patients are divided into three groups based on tumor stage before treatment. Group 1 includes patients with early-stage tumors who may undergo local excision or endoscopic resection followed by experimental chemoradiotherapy and a Watch and Wait strategy if surgery is declined. Group 2 involves patients with cT2N0 tumors offered an alternative experimental chemoradiotherapy approach with restaging to decide on organ-sparing strategies or local excision. Group 3 patients with more advanced tumors receive standard chemoradiotherapy and may be considered for organ-sparing methods if they respond well. If organ-sparing is not possible, minimally invasive surgery is performed with nerve preservation and enhanced recovery protocols. Participants undergo thorough imaging and diagnostic assessments including pelvic MRI, CT scans, PET, endorectal ultrasound, and rectoscopy for accurate staging and restaging. The study monitors clinical and pathological responses, quality of life, bowel function, and long-term disease outcomes. Close surveillance follows organ-preserving treatments. The primary outcome is development of a scoring system to predict complete tumor response. Participants are followed for several years to assess survival, quality of life, and bowel function after different treatment approaches.

Researchers are conducting a master protocol trial designed to efficiently study several different drugs for children and young adults with various types of cancer. This approach allows multiple clinical trials under one common research plan, with each trial focusing on specific cancers like desmoplastic small round cell tumor, synovial sarcoma, and Ewings sarcoma. New drug studies may be added over time as new treatments emerge. Participation depends on how long the treatment benefits last. The study evaluates combinations of drugs given in cycles, including intravenous and oral medicines such as ramucirumab, cyclophosphamide, vinorelbine, gemcitabine, docetaxel, abemaciclib, irinotecan, and temozolomide. Different treatment groups receive specific drug combinations tailored to the cancer type, with treatment cycles lasting 21 or 28 days depending on the regimen. Each group is randomized to receive either an experimental drug combination or an active comparator without any blinding. Participants will be involved from screening through treatment and monitored regularly. Researchers will assess how many participants are assigned to each specific intervention plan within the first four weeks and track treatment effects. Participants must have measurable or evaluable disease, adequate organ function, and meet performance status criteria. Female participants of childbearing potential undergo pregnancy testing and must use contraception during and after treatment. Safety, adherence, and side effects are carefully monitored throughout the study, which is expected to continue until 2027.

Researchers are evaluating the plasma expression of miRNA 371a-3p miRNA 371 as a specific marker to detect the presence or absence of viable germ cell malignancy in male patients newly diagnosed with testicular germ cell tumors or those with a history of this cancer. This observational cohort study aims to understand how well miRNA 371 can indicate relapse risk in early-stage testicular seminoma and nonseminoma groups. The study is sponsored by Fondazione del Piemonte per lOncologia and focuses on measuring miRNA levels and relapse outcomes over 48 months. Patients are grouped based on their risk of relapse low risk 5-25% chance or moderate risk 26-50% chance. Those in the low-risk group will follow a low-intensity schedule involving biospecimen collection and imaging, while the moderate-risk group will have a higher intensity schedule including additional early imaging and classic cancer marker tests. The study observes these patients without administering any investigational treatments. Participants will undergo regular blood tests to measure miRNA 371 levels and classic tumor markers like beta-HCG, AFP, and LDH. Imaging and clinical evaluations will be done within 42 days before registration and monitored over the 48-month study period. Researchers will track relapse rates, relapse-free survival, and overall survival, collecting pathology reports and performance status data. Participants must provide informed consent and blood samples throughout the study duration.

Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies MAB in patients with B-cell Non-Hodgkin Lymphoma NHL treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.

Researchers are conducting a retrospective study called ALFAOMEGA-RETR to collect clinical, imaging, and biological data from patients diagnosed with colorectal cancer CRC. The study aims to support precision research by analyzing these data to develop a new classification of CRC based on evolutionary patterns and to explore innovative biomarker-driven treatment approaches. This effort is part of a larger multi-institutional research program focusing on colorectal cancer heterogeneity. The study involves gathering data and samples from at least 500 CRC patients across various disease stages. These include clinical records, imaging scans such as CT, MRI, and PET, and biological materials like formalin-fixed paraffin-embedded tissue from surgeries or biopsies, as well as frozen samples including blood, plasma, stool, and others. This protocol operates retrospectively and collects information from patients who are no longer reachable for consent due to death or loss to follow-up. Participants themselves are not actively involved, as the study relies on previously collected data and archived samples. Researchers will analyze the number of CRC cases recruited retrospectively over six months. The collected data will support experimental research to deepen understanding of CRC and assist in developing targeted therapies. The study is observational and will continue through December 2026.