Marshall

This research aims to evaluate the effectiveness and safety of a combination of three drugsinavolisib, ribociclib, and fulvestrantcompared to a placebo combined with ribociclib and fulvestrant. It focuses on people with advanced breast cancer that is resistant to endocrine therapy, specifically those with hormone receptor-positive, HER2-negative disease who have certain genetic markers related to chromosome 8p loss and no PIK3CA mutation. The study is conducted as a phase II, randomized, double-blind, placebo-controlled trial to explore treatment options in this patient group. Participants are randomly assigned to receive either inavolisib along with ribociclib and fulvestrant or a placebo with ribociclib and fulvestrant. Each drug is given according to a specific schedule outlined in the study protocol, though exact dosing details are not provided here. This setup allows researchers to compare the results and safety profiles of the combination treatment against the placebo combination over the course of the study. Throughout the trial, participants undergo regular assessments to measure treatment response, including the percentage of participants with confirmed objective response, progression-free survival, overall survival, duration of response, and clinical benefit rate. The study also tracks adverse events and patient-reported side effects using validated questionnaires. These evaluations may continue for up to approximately two years, ensuring thorough monitoring of both effectiveness and safety during the participants involvement.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with advanced urothelial cancer that has spread locally or to other parts of the body. This phase III trial focuses on patients whose cancer has not responded to prior anti-PDL1 therapy. The study aims to compare overall survival, progression-free survival, response rates, duration of response, treatment side effects, and quality of life between the new combination therapy and usual chemotherapy care. Participants are randomly assigned to one of two treatment groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in 21-day cycles for up to six cycles or until disease progression or unacceptable side effects. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 every 21 days for up to 35 cycles or two years, unless disease progresses or side effects become unacceptable. Both groups undergo blood tests and imaging scans like CT or MRI throughout the study. During the trial, participants will have regular assessments including blood sample collection and imaging to monitor their cancer status and treatment effects. Researchers will also evaluate patient-reported quality of life and fatigue at multiple time points up to 12 months. After completing treatment, participants are followed up 30 days later and then annually for five years to track survival and health outcomes. This comprehensive approach helps researchers understand both the clinical outcomes and the impact on patients well-being over time.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are investigating the wide range of molecular features found in people receiving care within a large community healthcare system who are at risk of or diagnosed with cancer. The study aims to understand the genetic factors behind premalignant and malignant conditions across various cancer types and stages. This research helps advance knowledge of cancer biology and supports the discovery of biomarkers linked to clinical outcomes. Participants will undergo comprehensive molecular profiling, including somatic tumor testing from tissue andor blood samples using next-generation sequencing. Some samples may also receive whole exome or transcriptome sequencing for research purposes. Pharmacogenomic testing will help explore how individuals respond differently to medications, and participants may optionally provide microbiome samples. Participants may also consent to store biological samples in a biobank and allow their de-identified data to be used for future research. During the study, electronic health records will be reviewed both retrospectively and prospectively to connect clinical data with genomic findings. Researchers will measure how many patients undergo molecular profiling, are referred for genetic testing or targeted clinical trials, and have therapy changes based on molecular or pharmacogenomic results. The study spans five years, with long-term follow-up and data collection to support ongoing research and collaboration in cancer studies.

Researchers are evaluating the effectiveness of trastuzumab deruxtecan T-DXd combined with either rilvegostomig or pembrolizumab compared to standard chemotherapy with carboplatin and paclitaxel plus pembrolizumab in treating women with HER2-expressing, mismatch repair proficient pMMR, advanced or recurrent endometrial cancer. This Phase III study focuses on progression-free survival PFS as the main measure of treatment success. Participants are randomly assigned to one of three groups Arm A receives T-DXd and rilvegostomig intravenously every three weeks Arm B receives T-DXd and pembrolizumab intravenously every three weeks Arm C receives carboplatin and paclitaxel intravenously every three weeks for six cycles plus pembrolizumab every three weeks, followed by pembrolizumab maintenance every six weeks for up to 20 total cycles or about 24 months. Docetaxel may replace paclitaxel if needed. Treatment continues until disease progression or other reasons to stop treatment. During the study, participants undergo regular assessments including imaging and laboratory tests to monitor disease status and treatment effects. Researchers will evaluate progression-free survival until disease progression or death, overall survival, response rates, safety, pharmacokinetics, and patient-reported tolerability over periods ranging up to approximately 70 months. Safety monitoring continues for 90 days after the last dose. The study aims to better understand treatment options for this type of endometrial cancer.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.

Researchers are evaluating the effects of taking olaparib for one year compared to two years, with or without the addition of bevacizumab, in patients with stage III or IV ovarian cancer that has specific genetic mutations BRCA 12 or a deficiency in homologous recombination. This phase III trial aims to determine if shorter treatment with olaparib is not worse than longer treatment and to study survival, disease progression, toxicity, and other outcomes. The study also explores genetic markers that might predict treatment response. Participants are randomly assigned to one of two groups. In the first group, patients take olaparib orally twice daily for up to two years and may receive bevacizumab intravenously every 21 days for up to one year. In the second group, patients receive olaparib twice daily for up to one year and may also receive bevacizumab on the same schedule. Both groups undergo blood sample collection and imaging scans such as CT or MRI during the study treatment period. After finishing treatment, participants are followed up every three months for two years and then every six months for another three years to monitor health and disease status. Researchers assess progression-free survival based on tumor scans and survival over up to five years. Side effects, including risks of certain blood disorders and secondary cancers, are tracked. The total participation duration may extend over several years, including treatment and long-term follow-up.

This trial evaluates the addition of trastuzumab and hyaluronidase-oysk Herceptin Hylecta or pertuzumab, trastuzumab, and hyaluronidase-zzxf Phesgo to standard chemotherapy with paclitaxel and carboplatin in patients with HER2 positive endometrial cancer. The goal is to see if these combinations can better shrink tumors and improve outcomes by targeting HER2 receptors on cancer cells. This is a phase III trial involving women with specific types of endometrial cancer, including serous carcinoma and carcinosarcoma. Participants are randomly assigned to one of three treatment groups. One group receives paclitaxel and carboplatin alone. The second group receives paclitaxel, carboplatin, and trastuzumabhyaluronidase-oysk with possible maintenance therapy for up to 3 years. The third group receives paclitaxel, carboplatin, and pertuzumabtrastuzumabhyaluronidase-zzxf with similar maintenance. Treatments are given intravenously or by injection under the skin every 3 weeks in cycles lasting about 6 cycles, with additional cycles possible if disease remains stable or partially responsive. Throughout the study, participants undergo heart function tests echocardiography or MUGA and CT scans to monitor disease and side effects. Optional blood and urine samples may be collected, and vaginal brachytherapy may be administered. After treatment ends, participants are followed every 3 months for 2 years, then every 6 months for another 3 years. The study measures progression-free survival, overall survival, treatment side effects, tumor response, and quality of life over up to 5 years.