Bento Goncalves

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating whether adding intismeran autogene to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) remain cancer-free longer compared to pembrolizumab with a placebo. This study focuses on patients with NSCLC whose tumors did not completely respond to treatment before surgery and aims to prevent the cancer from returning. It is a Phase 3 randomized, double-blind study involving participants with resectable Stage II to IIIB (N2) NSCLC. Participants receive treatments including pembrolizumab given as an intravenous infusion and either intismeran autogene or placebo administered as an intramuscular injection. Before surgery, patients have received neoadjuvant pembrolizumab combined with platinum-based doublet chemotherapy, but only those who did not achieve a complete pathological response are eligible. The study compares the effects of pembrolizumab with or without intismeran autogene following surgery. During the study, participants are closely monitored for disease-free survival over a period of up to approximately 97 months. Researchers will assess whether the cancer returns and evaluate overall safety. Participants undergo regular evaluations including clinical assessments and laboratory tests to monitor their health and treatment response throughout the study period.

Researchers are evaluating the safety and effectiveness of a new oral medicine called vepugratinib compared with a placebo in adults with advanced or metastatic urothelial carcinoma, a type of bladder cancer that has a specific FGFR3 genetic alteration. This Phase 3 study aims to see if vepugratinib combined with two other drugs, enfortumab vedotin (EV) and pembrolizumab, can improve treatment outcomes for people who have not received prior systemic therapy for their cancer. Participants will receive either vepugratinib or placebo taken orally alongside enfortumab vedotin and pembrolizumab, both administered by intravenous infusion. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the vepugratinib and placebo groups. Treatment and monitoring will continue for up to approximately 6 years, allowing long-term assessment of safety and treatment effects. During the study, participants will be regularly evaluated for treatment-related side effects, response rates, and how long the cancer remains controlled without progression. Researchers will use established criteria to measure tumor response and will conduct thorough safety monitoring over the entire study period. Participation may last up to six years, during which participants will undergo laboratory tests, imaging, and clinical assessments to track their health and treatment response.

Researchers are evaluating an experimental drug called linvoseltamab (REGN5458) for adults with relapsed or refractory multiple myeloma who have had one to four previous treatments and have standard treatment options available. This phase 3 study compares linvoseltamab to a combination of three cancer drugs: elotuzumab, pomalidomide, and dexamethasone (EPd). The study aims to assess the safety and effectiveness of linvoseltamab compared to EPd, including how long participants benefit, tumor response, side effects, survival, and pain improvement. Linvoseltamab is given by intravenous infusion, while the comparison group receives elotuzumab by infusion and pomalidomide capsules and dexamethasone tablets or capsules by mouth or IV. Participants are randomly assigned to receive either linvoseltamab or the EPd combination. The study includes participants who have previously received lenalidomide, a proteasome inhibitor, and in some cases, a CD38 antibody. Treatment continues as per protocol with ongoing monitoring. Participants will undergo regular assessments to evaluate their disease response and side effects. Researchers will monitor progression-free survival for up to approximately five years. Assessments include measuring tumor response, survival, pain levels, and safety. Participants must have measurable disease and adequate organ function, and they will be followed closely to assess how well the treatments work and their safety over time.

Researchers are evaluating the use of adjuvant chemotherapy in patients with locally advanced cervical cancer who test positive for cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) in their plasma after standard treatment. This Phase 3, randomized, multicenter clinical trial aims to determine if patients with persistent cfHPV-DNA expression after chemoradiotherapy can benefit from additional chemotherapy. The study includes patients with cervical cancer stages IB3 to IVA who have completed standard concomitant chemoradiotherapy.

Researchers are evaluating treatments for advanced breast cancer characterized by estrogen receptor-positive, HER2-negative, and ESR1-mutated tumors. This study focuses on patients whose cancer has progressed despite previous endocrine therapy and CDK4/6 inhibitor treatment. The goal is to determine the effectiveness of combining elacestrant, a selective estrogen receptor degrader, with everolimus, a kinase inhibitor, compared to elacestrant with a placebo. This phase 3 trial aims to assess how well these treatments prolong the time patients live without disease progression or unacceptable side effects. A total of 240 patients will be randomly assigned to one of two groups: one receiving 345 mg of elacestrant plus 7.5 mg of everolimus daily, and the other receiving 345 mg of elacestrant plus a placebo daily. Treatment cycles last 28 days and continue until disease progression, unacceptable toxicity, death, or other reasons for stopping. Patients will be grouped based on the presence of visceral metastases and prior duration of CDK4/6 inhibitor therapy. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are tracked every three months for up to 12 months after the last patient is enrolled. Participants will undergo regular assessments including imaging scans to monitor cancer status and safety evaluations. The main measure is progression-free survival, defined as the time from treatment start until tumor progression, death, or discontinuation for other reasons, monitored on average for 12 months. Safety and treatment effectiveness will be closely followed throughout the study, with additional tumor assessments for those who stop treatment for reasons other than progression until new cancer therapy begins, death, or disease progression occurs.

Researchers are establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN), a study enrolling at least 5,000 men with advanced prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (M0/M1 CRPC). This international cohort will collect data from patients across various countries including Australia, Barbados, Brazil, Canada, and others to better understand differences in care and treatment across academic and community settings worldwide. Participants will receive standard care treatments for metastatic prostate cancer as determined by local practices. The study will collect detailed data at enrollment and during follow-up for a minimum of five years. Blood samples and, when feasible, tumor tissue will be collected at enrollment, at treatment changes, and at one-year follow-up to help identify molecular markers related to treatment response and resistance. During participation, patients will complete patient-reported outcome measures (PROMs) at enrollment and every three months. Physicians will provide questionnaires at enrollment, treatment changes, one-year follow-up, and treatment discontinuation. Researchers will track overall survival, adverse events, comorbidities, treatment changes, and patient quality of life to identify optimal treatment sequences and outcomes for men with advanced prostate cancer.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating the effectiveness and safety of puxitatug samrotecan compared to the physician's choice of chemotherapy in women with advanced or metastatic endometrial cancer that expresses the B7-H4 marker. These participants have had cancer progression after treatment with platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapies. This Phase III global, open-label study aims to determine whether puxitatug samrotecan can help participants live longer without their cancer worsening or simply live longer overall, while also assessing the impact on quality of life. Participants will be randomly assigned to one of two treatment groups. One group will receive puxitatug samrotecan given by intravenous infusion at a dose of 2.4 mg/kg on Day 1 every three weeks. The other group will receive the physician's choice of chemotherapy: either doxorubicin given intravenously at 60 mg/m2 on Day 1 every three weeks, or paclitaxel given intravenously at 80 mg/m2 on Days 1, 8, and 15 in a 28-day cycle. The study plans to enroll about 700 eligible participants worldwide. During the study, participants will undergo regular assessments to monitor their cancer progression and overall survival for approximately three years. Researchers will evaluate tumor measurements using imaging and assess participants' quality of life. Safety will be closely monitored throughout the treatment period, and participants' health status will be followed to determine the effects of the treatments over time.

Researchers are investigating whether olomorasib combined with pembrolizumab is more effective than pembrolizumab plus placebo for participants with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) in part A. In part B, they are assessing if olomorasib combined with durvalumab is more effective than durvalumab plus placebo for participants with unresectable KRAS G12C-mutant NSCLC. This Phase 3 study may last up to 3 years for each participant.