Candiolo

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating a stage-specific, personalized treatment approach for patients with rectal adenocarcinoma, focusing on preserving organs and using minimally invasive techniques. Patients are divided into three groups based on their tumor stage before treatment. The study aims to reduce the physical and psychological impact of surgery, especially in early-stage cancers, and explores alternatives like chemoradiotherapy and less invasive surgeries when appropriate. Treatment depends on the patient's group: early-stage tumors (Group 1) may receive local excisions or experimental chemoradiotherapy followed by careful monitoring. Intermediate tumors (Group 2) are usually treated with surgery but may receive experimental chemoradiotherapy to allow organ-sparing approaches if there is a good response. Advanced tumors (Group 3) start with standard chemoradiotherapy, and those responding well might also avoid major surgery through organ-sparing methods. If organ preservation isn't possible, minimally invasive surgery methods such as laparoscopic or robotic resections are used to improve recovery and reduce side effects. Participants undergo thorough staging and restaging using MRI, CT scans, PET scans, ultrasound, and rectoscopy to assess tumor response. Those achieving complete or near-complete responses may follow a Watch and Wait strategy or have less invasive surgeries. The study measures outcomes like pathological complete response over four years and monitors safety and quality of life. Recovery protocols aim to enhance patient well-being and faster return to daily activities throughout the trial.

Researchers are conducting a master protocol study called CAMPFIRE to efficiently carry out multiple clinical trials testing new drugs in children and young adults with cancer. This master protocol allows for adding new studies as new cancer drugs become available, focusing on the treatment of measurable or evaluable tumors in participants aged 1 to 39 years. The goal is to evaluate various drugs under a unified research plan to improve treatment options for young cancer patients. The study involves several investigational drugs administered either intravenously or orally, including Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel, Abemaciclib, Irinotecan, and Temozolomide. Each drug is tested under specific clinical trials within the master protocol, with treatment schedules and dosing tailored to each drug. Participants receive these treatments following standard clinical procedures, with adjustments based on individual study protocols and treatment responses. Participants will be closely monitored throughout the trial, with assessments including performance status evaluations, laboratory tests to check organ and blood function, and pregnancy testing for females of childbearing potential. Researchers will track how many participants receive each treatment during the first four weeks and observe the duration of treatment benefits. Safety evaluations, adherence to contraceptive measures, and recovery from prior therapies are also part of the study monitoring. Participation duration and additional assessments depend on the specific trial and treatment plan assigned.

Researchers are evaluating miRNA 371a-3p as a specific marker to detect the presence or absence of viable germ cell malignancy in male patients with newly diagnosed or history of germ cell tumors. This observational cohort study focuses on testicular germ cell tumors, aiming to assess the plasma expression of miRNA 371 as a biomarker for relapse and its ability to identify malignancy in early-stage testicular seminoma and nonseminoma groups. Patients are classified by relapse risk to tailor monitoring intensity. Participants with newly diagnosed testicular germ cell cancers are divided into low-risk (5-25% chance of relapse) and moderate-risk (26-50% chance of relapse) groups. Low-risk patients follow a less intensive schedule for biospecimen collection and imaging, while moderate-risk patients undergo more frequent biospecimen collection, imaging including early repeat scans, and classic tumor marker tests. The study does not involve specific treatment interventions but focuses on monitoring and biomarker evaluation. During the study, male participants aged 18 and older will provide blood samples for miRNA 371 measurement and undergo imaging, laboratory tests including beta-HCG, AFP, and LDH, along with clinical assessments. These evaluations occur within 42 days prior to registration and continue through a 48-month follow-up period. Researchers will measure miRNA 371 levels and check for malignant cells in plasma samples to monitor disease status and relapse over time.

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include 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 incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are conducting a retrospective study called ALFAOMEGA-RETRÒ to collect clinical and imaging data, along with biological samples, from patients diagnosed with colorectal cancer (CRC). This study supports a multi-institutional research program aimed at understanding the evolving heterogeneity of CRC by investigating mechanisms and developing therapies. The goal is to create a new classification system for CRC based on evolutionary patterns and to develop innovative biomarker-driven treatment strategies. The study involves gathering data from past clinical practices without altering patient care. Researchers will collect various types of information including demographics, medical history, cancer diagnosis and treatment details, as well as imaging data such as CT scans, MRI, and PET scans. Biological samples will include formalin-fixed paraffin-embedded tissue from surgeries or biopsies, as well as frozen samples like blood, plasma, peripheral blood mononuclear cells, stools, buccal swabs, and urine. Participants' involvement consists of providing access to their previously collected medical records, imaging, and tissue samples. Researchers will analyze these data and samples to validate and correlate biomarkers identified in ongoing translational projects. The primary outcome is the number of retrospectively recruited colorectal cancer cases within six months. This study relies on existing data and samples, with no new treatments or interventions administered to participants.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are comparing how long participants with KRAS/NRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer remain disease-free and their overall survival time when treated with two different regimens. This phase 3 study focuses on patients who have previously received chemotherapy. The study aims to evaluate progression-free survival and overall survival in participants receiving amivantamab plus FOLFIRI versus cetuximab or bevacizumab plus FOLFIRI. The study involves two treatment groups: one receiving amivantamab combined with chemotherapy drugs 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan (FOLFIRI), and the other receiving either cetuximab or bevacizumab with the same chemotherapy regimen. Participants will be randomly assigned to one of these treatment arms. The treatments will be administered according to protocol to assess their effects on the cancer. Participants will be monitored for up to 2 years and 1 month to measure progression-free survival through blinded independent central review and followed for overall survival for up to 4 years and 4 months. The study includes assessments of tumor response, safety, and other clinical evaluations. Tissue samples and detailed clinical data will also be collected. This comprehensive monitoring will help determine the comparative effectiveness of the treatment options over time.

The PRO-ACTIVE study focuses on cancer prevention across all stages, aiming to intervene before symptoms or imaging detect disease. It includes research on genetic and biological factors linked to hereditary tumors and aims to improve early diagnosis and risk prediction for cancers including breast, ovarian, colorectal, melanoma, and non-small cell lung cancer. The study combines retrospective and prospective analyses to better understand tumor biology, genetic predispositions, and immune responses. The study involves several work packages: WP1 uses integrated DNA-RNA methods to identify hereditary tumor markers; WP2 analyzes biological and molecular data to monitor recurrences; WP3 studies immune status in relation to genetics and environment; WP4 investigates the tumor microenvironment to predict recurrences. Patients are grouped based on genetic testing results and tumor types, with specific cohorts including patients with hereditary inheritance, those at risk without confirmed genetic tests, and patients negative for routine genetic analysis but further studied for hidden genetic variants. Blood and tumor tissue samples are collected at various stages for detailed analysis. Participants undergo retrospective analysis of tumor tissue samples from past surgeries and prospective enrollment with blood draws for DNA, RNA, circulating tumor DNA, circulating tumor cells, and immune cell studies. Tumor tissue collected during surgery is also analyzed using advanced sequencing techniques. Researchers measure the presence and frequency of genetic variants not detected by routine tests over a 12-month follow-up. The study includes detailed monitoring of biological, molecular, and immunological factors to better understand cancer risks and recurrence, with participant involvement lasting through sample collection and follow-up.