San Jose

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.

This research focuses on participants with cancer who were previously enrolled in Genentech and/or F. Hoffmann-La Roche sponsored studies. It aims to provide continued treatment with Roche investigational medicinal products (IMPs) or comparator agents for those who are still receiving study treatment at the time they transition from the parent study and lack access to the treatment locally. The study is an open-label, multicenter phase 3 extension trial designed to offer ongoing therapy for eligible participants. Participants will continue receiving the same Roche IMPs or comparator agents at the doses, schedules, and administration methods that were in effect at the time they stopped treatment in the parent study. Treatments include drugs like Ipatasertib, Tiragolumab combined with Atezolizumab, Atezolizumab alone or in combination, Bevacizumab alone or with Atezolizumab, Entrectinib, Inavolisib, and Divarasib with or without other agents. The first dose in this extension study must be given within 7 days of the allowed treatment interruption from the parent study. During the study, researchers will monitor participants for continued access to the study treatments and track any adverse events using standard criteria for up to about 10 years. Participants must comply with study protocols and will be regularly assessed for safety and ongoing benefit from the treatment. This long-term follow-up is designed to gather data on treatment continuation, safety, and tolerability over an extended period.

This research aims to compare intismeran autogene combined with pembrolizumab versus placebo with pembrolizumab as an additional treatment after surgery for people with stage II, IIIA, or IIIB (with nodal involvement) non-small cell lung cancer (NSCLC) that has been fully removed with clear margins. The study is a phase 3 trial investigating whether the combination including intismeran autogene improves disease-free survival compared to the placebo combination. Participants will receive either intismeran autogene by intramuscular injection plus pembrolizumab by intravenous infusion or a placebo injection plus pembrolizumab. The treatments are given after surgery and standard platinum-based chemotherapy. No more than 24 weeks can pass from surgery to the first pembrolizumab dose. The study evaluates these treatments as adjuvant therapy to reduce cancer recurrence. During the trial, researchers will monitor participants for disease-free survival for up to approximately 78 months. Participants undergo regular assessments including medical evaluations to track cancer status and treatment effects. The study excludes those with prior neoadjuvant therapy, certain infections, or other cancer treatments that might interfere. Safety and long-term outcomes are carefully observed throughout the study period.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

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 evaluating the effects of the ABC Bicuspid Sizing Algorithm on clinical outcomes for patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. This study aims to determine whether the algorithm improves technical success immediately after the procedure and device success 30 days post-procedure. It is a multi-center, international, prospective cohort study enrolling about 290 patients eligible for TAVR or surgical aortic valve replacement (SAVR). The ABC Bicuspid Sizing Algorithm helps doctors assess CT scans to guide decisions on whether patients should receive TAVR or SAVR and to select the appropriate valve size for TAVR patients. In some cases, gated CT scans or artificial intelligence-based simulations are used for further evaluation. Physicians consider these findings along with other clinical factors to decide on the final treatment and valve deployment. About 230 patients are expected to undergo TAVR using the Sapien 3 valve. Participants will have data collected at several points: before the procedure, during the procedure, at hospital discharge, and at 30 days and one year after the procedure for TAVR patients. SAVR patients will have data collected only at baseline and during their procedure. The main outcome measured is the proportion of cases achieving technical success immediately after the procedure. The study includes sites across Canada, Latin America, the Middle East, and Asia Pacific regions.

This research aims to evaluate the safety and effectiveness of zilovertamab vedotin (ZV) combined with standard treatments for participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). It is a Phase 2/3, randomized, open-label, multisite study including participants aged 18 and older. The study tests two main hypotheses: that ZV combined with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is better than R-GemOx alone for progression-free survival; and that ZV combined with bendamustine rituximab (BR) is better than BR alone. However, enrollment in the BR and ZV + BR arms is discontinued, so no outcome analysis will be done for those groups. The study is split into two parts: Part 1 confirms the dose of ZV, and Part 2 expands to evaluate its efficacy. Participants receive intravenous infusions of ZV at various doses, along with standard drugs including rituximab, gemcitabine, oxaliplatin, and bendamustine as appropriate. Prophylactic granulocyte colony-stimulating factor (G-CSF) is given with each ZV cycle according to institutional guidelines. Treatment schedules and doses are carefully managed to assess safety and treatment effects. During the study, participants will be monitored for dose-limiting toxicities up to about 6 weeks, and adverse events for up to approximately 68 months. Researchers will also track treatment discontinuations due to adverse events. Key outcomes include overall survival and progression-free survival up to about 35 months. Participants will have regular assessments including scans, clinical evaluations, and laboratory tests to measure response and monitor safety throughout their participation.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

This clinical trial is designed to evaluate the safety and effectiveness of a canaloplasty device in adults with open-angle glaucoma who are also undergoing cataract surgery. The trial focuses on subjects diagnosed with open-angle glaucoma characterized by specific eye pressure levels. It aims to gather data on how this new surgical system performs in a real-world setting. Participants in the study will receive treatment using the DF12 Canaloplasty and Trabeculotomy Surgical System during their cataract surgery. This device is intended to help manage eye pressure associated with glaucoma. The trial is prospective and multicenter, involving several locations to assess the device's safety and effectiveness in a first-in-human setting. Throughout the study, researchers will monitor changes in eye pressure over a 12-month period after treatment. Participants will be evaluated for safety and the impact of the device on glaucoma management. The total duration and follow-up include assessments to ensure ongoing monitoring of the treatment outcomes and any potential side effects.

This research aims to evaluate the safety, usability, and effectiveness of a new accommodating intraocular lens (IOL) called AAL-FAIOL in adults needing cataract surgery in both eyes. The study takes place in Central America and focuses on patients diagnosed with bilateral cataracts requiring lens removal by phacoemulsification, a surgical technique using ultrasound to remove the cloudy lens. The goal is to compare the new AAL-FAIOL lens with the standard BAL-FAIOL lens in the same participants. Participants will undergo cataract surgery in each eye separately, with one eye receiving the AAL-FAIOL and the other the BAL-FAIOL. The eye surgeries will be spaced 14 to 35 days apart. The AAL-FAIOL lens may be adjusted post-surgery using laser energy to improve vision for distance if needed. Both lenses are implantable devices designed for long-term use inside the eye's lens capsule. During the approximately one-year follow-up, participants will attend scheduled visits to monitor eye health and vision. Researchers will assess cumulative eye-related adverse events, including any secondary surgical interventions, from day of surgery up to 12 months. The study will track safety, lens performance, and any adjustments required to optimize vision over the course of the year.