Brandywine

Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for people aged 18 and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study includes participants who have not received prior treatment for advanced or metastatic disease and are in good health based on medical tests. This research is designed as a Phase 2/3 trial to learn about safety, response, and compare this new treatment to an approved therapy called nivolumab plus chemotherapy. The study has two parts: the first part assesses the safety and response to PF-08634404 with chemotherapy, and the second part compares this combination to nivolumab with chemotherapy. Treatments are given intravenously in repeated cycles. Participants receive either PF-08634404 plus chemotherapy or nivolumab plus chemotherapy based on the study phase and group assignment. During the study, participants undergo regular evaluations including medical tests to monitor organ function and safety. Researchers will measure treatment response using RECIST 1.1 criteria, track adverse events, and assess progression-free survival and overall survival over approximately four years. Follow-up continues through 90 days after the last treatment to monitor side effects and overall health.

Researchers are conducting the FLEX Registry to study patients with stage I to III breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor. This large-scale, population-based, prospective registry aims to create a comprehensive database of full genome expression linked with clinical data to explore new gene associations that may have prognostic or predictive value. The registry uses an adaptive design, allowing additional targeted substudies and arms to be added over time. The study involves patients from over 125 U.S. institutions, with an anticipated enrollment of around 30,000 participants. Treatment decisions are made by physicians following NCCN-approved regimens or recognized alternatives. MammaPrint and BluePrint tests are performed by Agendia using the full genome testing array. Data collection occurs at enrollment, during treatment, and at follow-up intervals of 1, 3, 5, and 10 years after diagnosis. Participants will have clinical data entered online at specified time points, with the goal of generating hypotheses for targeted subset analyses and further trials based on the genetic data collected. Outcome measures include the creation of a large registry for gene expression and clinical data over 10 years and the development of shared registry infrastructure to study smaller patient groups. This is an observational phase IV study focused on long-term data gathering and analysis.

Researchers are evaluating the effectiveness and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that tests positive for TROP2 but does not have actionable genomic alterations. This phase III, randomized, open-label, multicenter study also assesses the performance of a new diagnostic device to identify suitable participants. Eligible patients have previously been treated for their cancer and meet specific genomic and disease progression criteria. Participants will receive either datopotamab deruxtecan or docetaxel, both given through intravenous (IV) infusions. The study has two arms comparing these treatments directly. Treatment and monitoring will continue according to the study protocol. The investigational drug, Dato-DXd, is being closely evaluated against the standard chemotherapy drug docetaxel for its impact on disease control. During the study, participants will undergo various assessments including imaging scans to measure tumor response and disease progression. Researchers will monitor progression-free survival over approximately 2.5 years and overall survival over about 3.5 years. Other evaluations include performance status, laboratory tests, and safety monitoring to track side effects and overall health throughout the study period.

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer who have failed prior systemic therapies, including a platinum-based therapy and an immune checkpoint inhibitor, either separately or together.

Researchers are evaluating the effectiveness and safety of sacituzumab govitecan-hziy alone and in combination with other treatments for adults with metastatic urothelial cancer, a type of advanced bladder cancer that cannot be removed or has spread. This phase II study includes both non-randomized and randomized groups, although one cohort (Cohort 5) has been cancelled as of December 2023. The study aims to better understand how well these treatments work and their safety profiles for patients with this condition. Participants receive various treatments including sacituzumab govitecan-hziy administered intravenously, sometimes combined with drugs like pembrolizumab, cisplatin, avelumab, zimberelimab, carboplatin, gemcitabine, domvanalimab, and enfortumab vedotin. Treatment schedules and combinations vary based on the study cohort, with some groups receiving platinum-based chemotherapy or immunotherapies per their standard dosing instructions. Tumor tissue samples are required for certain groups, and measurable disease is assessed using CT or MRI scans following specific criteria. During the study, participants are closely monitored through imaging scans, laboratory tests, and assessments to measure treatment responses such as overall response rate and progression-free survival. Safety is tracked by recording any treatment-related side effects and laboratory abnormalities. Follow-up visits may continue for up to two years after the last dose, with some safety monitoring extending about three years. Participants' health and treatment effects are carefully evaluated throughout the study to gather comprehensive data on these therapies.

Researchers are evaluating whether a new medicine called PF-08634404 combined with chemotherapy is more effective than the current standard treatment, pembrolizumab with chemotherapy, for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 3 study focuses on adults 18 years and older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and have not received prior treatment for advanced disease. The study excludes participants with known actionable genomic alterations and aims to compare overall survival and progression-free survival over approximately 39 and 32 months, respectively. Participants are assigned to two parts based on their tumor type: squamous NSCLC patients in Part 1 and non-squamous NSCLC patients in Part 2. Within each part, participants are randomly assigned to receive either the experimental treatment PF-08634404 or the control treatment pembrolizumab, each combined with a chemotherapy regimen tailored to tumor type. Treatments are given via intravenous infusions in cycles, followed by maintenance therapy with either monotherapy or combination therapy depending on the study part. Treatment continues as long as it is beneficial and side effects remain manageable. During the study, participants will have regular visits for treatment administration and health evaluations. Cancer response will be monitored with tests every 6 weeks for the first 48 weeks and then every 12 weeks afterward. Researchers will assess overall survival and progression-free survival, ensuring thorough monitoring of participants' health and treatment effects throughout the study period.