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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 safety and effectiveness of BMS-986504 given alone to participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) who have a specific genetic change called homozygous MTAP deletion. This study focuses on patients whose cancer has progressed despite prior treatments and is a Phase 2 trial designed to better understand how this drug works in this specific group. Participants receive BMS-986504 at specified doses on certain days as the main treatment. This study does not mention comparison groups, and all participants receive this investigational drug to assess its impact on their cancer. During the study, researchers will monitor participants for up to three years after their last dose to see how many achieve an objective response based on standard criteria for measuring tumor shrinkage. Participants will undergo evaluations including scans and other assessments to track disease progression and treatment safety throughout the trial.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating sacituzumab tirumotecan alone and combined with pembrolizumab compared to the treatment chosen by a physician for people with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on participants whose cancer has progressed despite prior endocrine therapy, including treatment with a CDK4/6 inhibitor. The main goal is to see if these treatments improve progression-free survival, which means the length of time the cancer does not worsen, over up to approximately 38 months. Participants receive sacituzumab tirumotecan as an intravenous infusion, either alone or combined with intravenous pembrolizumab. The comparison group receives the treatment of physician's choice, which may include intravenous paclitaxel, nab-paclitaxel, liposomal doxorubicin, or oral capecitabine. The study is open-label and randomized, meaning participants are assigned to different treatment groups openly. Treatments are administered according to the study protocols, with ongoing monitoring during the treatment period. Throughout the study, participants are monitored regularly to assess their cancer status and overall health. This includes evaluations by blinded independent central review using RECIST 1.1 criteria to measure tumor progression. Researchers also assess safety, organ function, and performance status. The total participation time may last up to around 38 months to track progression-free survival and other outcomes. Careful monitoring helps ensure participant safety and collects data on treatment effectiveness and side effects.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with pembrolizumab can treat triple-negative breast cancer (TNBC). This phase 3 study compares these treatments to chemotherapy chosen by the physician, aiming to see if participants live longer or have longer periods without cancer growth or spread. The study focuses on people with previously untreated locally recurrent unresectable or metastatic TNBC with low PD-L1 expression. Participants receive sacituzumab tirumotecan through intravenous infusion alone or with pembrolizumab, also given intravenously. The study compares these to treatment options including paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin. Pre-medications like antihistamines, acetaminophen, and steroids are given before sacituzumab tirumotecan infusions to help reduce side effects. The trial evaluates safety and effectiveness over several months. Throughout the study, researchers monitor participants up to about 39 months for progression-free survival and up to about 61 months for overall survival. Participants undergo regular assessments to track cancer status and side effects. The study includes careful safety monitoring, and participants must meet specific health criteria to join. The total time in the study and follow-up depends on each participant's response and health status.

Researchers are evaluating the combination of BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in people with first-line metastatic non-small cell lung cancer who have a homozygous MTAP deletion. The study is a randomized phase 2/3 trial focused on assessing clinical benefits in this specific patient group. Participants will receive either BMS-986504 with pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on specified days. This treatment is administered as part of the first-line therapy for metastatic disease. During the study, researchers will monitor progression-free survival up to 2 and 5 years using RECIST v1.1 criteria and overall survival up to 5 years. Participants will be assessed regularly for disease progression and survival outcomes. The study includes detailed monitoring to evaluate the effects and safety of the treatment combination over time.

Researchers are evaluating the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are assessing the safety and effectiveness of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This phase 2/3 study focuses on participants with specific tumor characteristics, including PD-L1 status and HER2-negative cancer, aiming to provide new treatment options for this serious condition. Participants receive either Pumitamig along with chemotherapy drugs Folfox or Capox, or Nivolumab combined with chemotherapy, each given at specified doses on set days. The study is randomized and blinded, involving two parts: phase 2 and phase 3, with treatment tailored based on PD-L1 expression levels. During the study, researchers monitor tumor response using RECIST v1.1 criteria, track progression-free survival up to about 33 months, and overall survival up to approximately 47 months after randomization. Assessments include imaging and clinical evaluations to measure treatment effects and safety over the course of participation, which may last up to 2 years or more for certain outcomes.

Researchers are investigating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib to treat women and men with locally advanced or metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. This phase 3 study includes patients who have previously received treatment with ribociclib or palbociclib and aims to evaluate the effectiveness, safety, and tolerability of these treatment combinations. Participants will be randomly assigned to receive either oral lasofoxifene at 5 mg daily combined with oral abemaciclib 150 mg twice a day, or intramuscular fulvestrant 500 mg on specific days followed by monthly doses plus oral abemaciclib 150 mg twice daily. The treatment schedules are designed to compare how well these combinations work in managing the cancer. During the study, participants will be closely monitored for progression-free survival over approximately three years. Researchers will assess the cancer's response to treatment, track any side effects, and evaluate safety and tolerability. Regular evaluations and follow-ups will ensure comprehensive data collection to understand the impact of these therapies on advanced breast cancer.

Researchers are evaluating the safety and effectiveness of adding sacituzumab tirumotecan to pembrolizumab compared to the treatment of physician's choice in adults with triple-negative breast cancer (TNBC) who received neoadjuvant therapy but did not achieve a complete response after surgery. This Phase 3, randomized, open-label study aims to determine if the combination improves invasive disease-free survival (iDFS) over other approved treatments. The study focuses on participants who have residual disease after surgery and have recovered sufficiently to continue treatment. Participants receive either sacituzumab tirumotecan 4 mg/kg intravenously every two weeks combined with pembrolizumab 400 mg intravenously every six weeks, or treatment chosen by their physician, which may include pembrolizumab alone or pembrolizumab with oral capecitabine taken twice daily. Treatment is given after surgery and any indicated radiation therapy, with randomization occurring within 16 weeks post-surgery. The study monitors participants for up to about 77 months to assess long-term outcomes. During the study, participants undergo regular assessments including clinical evaluations and monitoring for disease recurrence, side effects, and overall health. Tissue samples collected at surgery are analyzed for biomarkers like TROP2. Safety is closely monitored, and participants must have good performance status to join. The study collects data on how long participants remain disease-free and tracks any adverse events to understand treatment effects over the extended follow-up period.