Peschiera Del Garda

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 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 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 evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

Researchers are evaluating the overall survival of males with chemotherapy-naefve metastatic castration-resistant prostate cancer (mCRPC). This phase 3 randomized study compares treatment with xaluritamig plus abiraterone to the investigator's choice of docetaxel, cabazitaxel, or abiraterone. Participants must have confirmed prostate adenocarcinoma with metastatic lesions and evidence of disease progression despite prior androgen receptor pathway inhibitor therapy. The study includes two treatment groups: one receiving intravenous xaluritamig combined with oral abiraterone acetate, and the other receiving the investigator's choice of chemotherapy drugs docetaxel or cabazitaxel administered intravenously, or abiraterone taken orally. Participants intended for cabazitaxel must have had up to six cycles of prior docetaxel in the metastatic hormone-sensitive setting. Treatments are administered per protocol during the randomized phase. Participants will be monitored for overall survival for up to approximately 51 months. Eligibility requires adequate organ function and good performance status. The study excludes those with prior chemotherapy in the mCRPC setting, certain prior therapies, unresolved toxicities, or CNS metastases. Researchers will assess survival outcomes along with safety and treatment tolerability throughout the study duration.

Researchers are evaluating the safety and effectiveness of a new combination treatment using BMS-986489 (a fixed dose combination of BMS-986012 and Nivolumab) alongside Carboplatin and Etoposide compared to the current standard treatment with Atezolizumab plus Carboplatin and Etoposide. This study focuses on adults with extensive-stage small cell lung cancer and is conducted as a phase 3 randomized, double-blind, multicenter trial. The goal is to find out which combination works better as a first-line therapy for this advanced lung cancer. Participants will receive either BMS-986489 combined with Carboplatin and Etoposide or Atezolizumab combined with Carboplatin and Etoposide. Each drug will be given at specified doses on certain days according to the study protocol. The study compares these two treatment approaches to see their effects and safety when used as initial therapy for extensive-stage small cell lung cancer. During the study, participants will be closely monitored over a period of up to 5 years to assess overall survival. Researchers will use imaging techniques like CT scans or MRIs to measure tumor response and will evaluate participants' health and ability to perform normal activities. Safety and side effects will also be tracked throughout the study to ensure participant well-being.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

Researchers are evaluating the effects of physical activity in adults with chronic kidney disease (CKD) who are either undergoing dialysis or receiving conservative treatment. The study compares a combined high-intensity aerobic and resistance exercise program to a control group. The goal is to understand how these exercise interventions might impact physical function and quality of life in this population. Participants will be randomly assigned to two groups: one that receives combined exercise training and a control group. The exercise group will participate in endurance and resistance training sessions three times per week for 24 weeks. The control group will have their outcomes monitored without receiving the structured exercise program. During the study, researchers will assess participants' gait speed, physical performance, cardiopulmonary capacity, strength of both lower and upper limbs, daily physical activity levels, and quality of life. These measurements will be taken throughout the study period, which lasts about one year. This comprehensive monitoring helps to understand the impact of the exercise program on overall health and daily function in CKD patients.

Researchers are evaluating sexual function changes over time in patients diagnosed with gynecologic cancers and their partners. The study aims to observe these changes without altering standard clinical care pathways. It addresses the often overlooked sexual dysfunctions and psychological impacts related to gynecologic cancers, highlighting the need for validated assessment tools and structured sexual counseling. The study is observational, exploratory, prospective, longitudinal, and multicenter in design. Participants and their partners are enrolled at diagnosis (T0), with follow-up assessments at six months after treatment start (T1) and twelve months after completing therapy or surgery (T2). Patients complete the Female Sexual Function Index (FSFI) questionnaire alongside additional questions about sexual experience, satisfaction, and difficulties. Male partners complete the International Index of Erectile Function (IIEF-15), while female partners complete the same questionnaires as patients. Sociodemographic, clinical data, lifestyle habits, and other relevant information are also collected. Throughout the study, participants complete questionnaires at three time points to measure changes in sexual function. The primary outcome focuses on FSFI and IIEF score changes across these assessments. Secondary outcomes include the perceived usefulness of sexual counseling and preferred timing for support. All data are collected with informed consent and stored securely. The study expects to enroll 200 patients and 200 partners and analyzes data longitudinally with appropriate statistical methods.