Bonney Lake

Researchers are evaluating a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

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 investigating targeted therapies approved by the Food and Drug Administration FDA for patients with advanced cancers that have specific genetic changes. This study, called the Targeted Agent and Profiling Utilization Registry TAPUR Study, aims to understand how safely and effectively these targeted drugs work when prescribed in real-world settings for cancers with actionable genomic variants. The study also collects data on molecular testing choices and helps generate ideas for future clinical trials. Participants receive one of several FDA-approved targeted anticancer drugs, chosen based on specific genetic features of their tumors. These drugs include palbociclib, sunitinib, temsirolimus, trastuzumab with pertuzumab, vemurafenib with cobimetinib, regorafenib, olaparib, nivolumab with ipilimumab, abemaciclib, talazoparib, atezolizumab with talazoparib, tucatinib with trastuzumab, futibatinib, dabrafenib with trametinib, and fam-trastuzumab deruxtecan-nxki. Each treatment follows the approved dosing schedule and duration. Different genetic alterations qualify patients for different drugs, and the study covers a wide range of tumor types, including advanced solid tumors, multiple myeloma, and non-Hodgkin lymphoma. During the study, participants undergo regular assessments including physical exams and imaging tests to measure tumor response using standard criteria. The main outcome measured is the percentage of patients with tumor shrinkage or stable disease after 16 weeks of treatment. Researchers also monitor overall survival for up to three years. Safety and organ function are closely tracked through laboratory tests. Participants must provide informed consent and meet specific eligibility criteria, including measurable disease and acceptable organ function. The study does not use random assignment, and results are shared publicly as they become available and at study completion.

Researchers are evaluating different dosing strategies of CDK46 inhibitors in patients aged 65 years or older with Hormone Receptor Positive HR and HER2-negative Metastatic Breast Cancer MBC. The study aims to compare the time patients remain on treatment using the standard approved dosing versus a titrated dosing approach that starts at a lower dose and increases if well tolerated. This Phase 3, randomized trial also explores patient-reported outcomes and baseline factors to help personalize treatment for older patients. Participants will choose either palbociclib or ribociclib as their CDK46 inhibitor and select an endocrine therapy partner, either an aromatase inhibitor or fulvestrant. They will be randomized to one of two groups Arm 1 receives the indicated dosing regimen starting at the full approved dose, while Arm 2 starts at a lower dose with potential escalation based on tolerance. Treatment cycles are 28 days long, with the CDK46 inhibitor taken daily for 21 days per cycle. Throughout the study, participants will be monitored for treatment duration, side effects, quality of life, dose adjustments, and healthcare use. Data will be collected up to 48 months, including patient questionnaires and clinical assessments to track tolerability and outcomes. Telehealth visits and remote consenting are permitted to facilitate participation. The study seeks to find dosing strategies that help older patients tolerate treatment longer and improve their clinical benefit.

Researchers are investigating whether combining the investigational drug mevrometostat PF-06821497 with enzalutamide works better than enzalutamide alone for men with metastatic castration-sensitive prostate cancer mCSPC who have not previously received androgen receptor pathway inhibitors ARPI or chemotherapy in this setting. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to compare these treatments to understand if the combination improves outcomes for participants. Participants will be randomly assigned to one of two groups one group will receive mevrometostat 875 mg twice daily plus enzalutamide 160 mg once daily, while the other group will receive a placebo plus enzalutamide 160 mg once daily. The study includes several phases Screening, Randomization, Treatment, Safety Follow-up, and Long-Term Follow-up. Prior short-term androgen-deprivation therapy ADT of up to 3 months is allowed if there is no disease progression before starting the study. During the study, participants will have regular assessments including radiographic scans to monitor disease progression, laboratory tests, patient-reported questionnaires on pain and quality of life, and blood samples to evaluate tumor DNA and drug levels. The main measure is radiographic progression-free survival tracked for up to about 4 years. Safety outcomes and overall survival will also be monitored for several years. The total participation may last up to nearly 9 years, including long-term follow-up to understand treatment effects and safety over time.

Researchers are evaluating the therapeutic cancer vaccine OSE2101 in patients with metastatic non-small cell lung cancer NSCLC who have developed secondary resistance to immune checkpoint inhibitors ICI. This phase 3, multicenter, randomized, open-label study focuses on HLA-A2 positive patients with either squamous or non-squamous NSCLC. The study aims to compare the efficacy and safety of OSE2101 with the standard treatment docetaxel, considering factors like cancer histology and performance status. Participants will be randomized in a 21 ratio to receive either OSE2101 monotherapy or docetaxel monotherapy. OSE2101 is administered as a subcutaneous injection of 5 mg peptides every three weeks for six cycles, then every eight weeks during the first year, and every twelve weeks until the end of the second year. Docetaxel is given as a 75 mgm2 intravenous infusion over one hour every three weeks. Additionally, a companion diagnostic device system is used to assess patient eligibility based on HLA-A2 phenotype. During the study, participants will have regular evaluations including clinical assessments and monitoring of survival time from randomization to death, which is the primary outcome measured over an average of three years. The study involves ongoing monitoring of treatment effects and safety. Participants can expect scheduled visits aligned with treatment cycles and assessments throughout the trial duration, which extends up to nearly five years from start to completion.