Bonney Lake

Researchers are evaluating a drug called sigvotatug vedotin alone and in combination with pembrolizumab, with or without chemotherapy, to determine its safety and effects in people with various advanced solid tumors. This Phase 1 study includes participants with specific cancers like non-small cell lung cancer, head and neck squamous cell cancer, HER2-negative breast cancer, esophageal cancers, ovarian cancer, and others. The trial aims to find out the side effects of sigvotatug vedotin and whether it can treat these solid tumors effectively. The study is divided into four parts. Part A focuses on finding the right dose of sigvotatug vedotin. Part B tests the safety and effectiveness of that dose. Parts C and D look at the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with chemotherapy drugs carboplatin or cisplatin. Participants receive these drugs intravenously, with pembrolizumab given every 3 or 6 weeks and chemotherapy every 3 weeks depending on the drug. During the study, participants undergo tumor biopsies, physical exams, and disease assessments to monitor treatment effects. Researchers track side effects, lab abnormalities, and dose-limiting toxicities for up to 30-37 days after the last dose of sigvotatug vedotin, and for up to 3 years after pembrolizumab treatment. The study follows participants with regular safety monitoring and evaluations of tumor response throughout the trial.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

Researchers are evaluating the use of FDA-approved targeted therapies in patients aged 12 years and older with advanced cancer, including solid tumors, multiple myeloma, and non-Hodgkin lymphoma. The study aims to understand the safety and effectiveness of these drugs when prescribed based on specific genetic changes found in tumors. This Phase 2 trial collects real-world data from patients whose cancer has not responded to standard treatments or for whom no standard treatment is available. Participants receive one or more targeted drugs selected according to their tumor's genetic profile. Some of the drugs studied include Palbociclib, Sunitinib, Temsirolimus, Trastuzumab and Pertuzumab, Vemurafenib and Cobimetinib, Regorafenib, Olaparib, and others. Treatment plans vary based on the specific drug and tumor genetics. The study does not include all possible targeted therapies in its published details, but additional information is available through the study contacts. During the study, participants are monitored regularly to assess their cancer's response to treatment, measured by complete or partial tumor shrinkage or disease stabilization at 16 weeks. Assessments include physical and radiographic exams and genomic testing. Safety and organ function are also monitored. The study collects ongoing data from participants, including their treatment outcomes and any side effects, with results shared publicly as they become available. The trial continues to enroll patients and follow their progress over time.

Researchers are evaluating whether combining the investigational drug mevrometostat (PF-06821497) with enzalutamide works better than enzalutamide alone in men with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received androgen receptor pathway inhibitors or chemotherapy in this setting. This Phase 3, randomized, double-blind, placebo-controlled study involves participants who have only received limited prior androgen-deprivation therapy and no evidence of disease progression before starting the study. Participants will be randomly assigned to one of two groups: one group receives oral mevrometostat together with oral enzalutamide continuously, while the other group receives a placebo with oral enzalutamide continuously. The study includes a Screening Phase, a Treatment Phase after randomization, followed by Safety Follow-up and Long-Term Follow-up periods to monitor outcomes and side effects. Throughout the study, participants will undergo regular assessments including imaging scans to evaluate disease progression, laboratory tests, and monitoring of symptoms and adverse events. The main outcome measured is Radiographic Progression Free Survival (rPFS) over approximately 4 years from randomization. Safety and long-term effects will also be monitored to understand how well participants tolerate the treatments and how the disease responds over time.

Researchers are conducting a phase 3, multicenter, randomized, open-label study to compare treatments in patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitor (ICI) therapy. The study focuses on patients positive for the HLA-A2 phenotype and includes both squamous and non-squamous types of NSCLC. Participants will be grouped based on cancer histology and their performance status to better understand treatment effects. Participants will be randomly assigned in a 2:1 ratio to receive either the experimental treatment OSE2101 or the standard treatment docetaxel. OSE2101 is a cancer vaccine made of nine specific peptide components targeting tumor-associated antigens, combined with an adjuvant to enhance immune response. Docetaxel, the control treatment, is a chemotherapy drug that disrupts cell division. The study uses an assay device to confirm HLA-A2 status before treatment allocation. During the average three-year study period, researchers will monitor overall survival, defined as the time from randomization until death. Patients will be regularly assessed for treatment response and safety. The trial aims to gather important data on the efficacy and tolerability of the OSE2101 vaccine compared to docetaxel in this patient population with metastatic NSCLC and secondary resistance to ICI therapy.