Highlands Ranch

Researchers are studying patients who have cancer or may be at risk of developing cancer to improve the standard of care. This observational study collects blood, tissue, and other biological samples along with associated data such as surveys, medical records, and cancer registry information. The goal is to enable new clinical trials, technology advancements, and personalized medicine for cancer patients over time. Participants provide consent to allow collection and storage of their biological samples and data. This includes blood and tissue samples as well as survey assessments and medical chart reviews. The study does not involve treatment but focuses on gathering information to support cancer research and care improvements. During the study, patients biological samples and data are collected and stored long-term. Researchers analyze survey responses, medical records, and biological specimens to measure outcomes related to improving cancer care standards. The study follows participants for up to 20 years, aiming for a lifetime partnership to support ongoing cancer research and care advancements.

Researchers are studying a new decision aid designed to help women recently diagnosed with early-stage breast cancer choose between lumpectomy and mastectomy. The study aims to assess how feasible and acceptable this tool is by gathering feedback from patients and observing the implementation process. This pilot study is a step toward planning a larger trial to compare the decision aid with the standard educational materials currently used. Participants will be randomly assigned to one of two groups. Patients in the treatment group will receive an electronic copy of the novel decision aid via email, which is designed to support shared decision-making by helping patients weigh risks and benefits based on their values. The control group will receive an electronic educational pamphlet that discusses surgical options for breast cancer, representing the standard of care. During the one-year study period, participants will complete various assessments including patient-reported outcomes using the BREAST-Q, decision aid evaluations, health literacy tests, distress screenings, web-based surveys, and semi-structured interviews. Researchers will measure how well patients receive and engage with the decision aid and use the results to guide future larger studies. The total participation involves completing these evaluations and providing feedback to improve the decision-making support process.

Researchers are conducting a Phase IbII, open-label, multicenter, randomized umbrella study to evaluate multiple immunotherapy-based treatment combinations in participants with advanced liver cancers. This study is designed to be flexible, allowing new treatment arms to open as new therapies become available and to close those with minimal activity or unacceptable toxicity. The initial focus is on participants with locally advanced or metastatic hepatocellular carcinoma HCC who have not received prior systemic therapy for their disease. Participants are randomly assigned to one of several treatment arms, receiving combinations such as atezolizumab plus bevacizumab, with additional drugs like tiragolumab, tocilizumab, TPST-1120, Tobemstomig, ADG126, IO-108, or NKT2152, depending on the arm. Treatments involve intravenous infusions or oral medications administered in cycles of 21 or 28 days, continuing until unacceptable toxicity or loss of clinical benefit occurs. Participants experiencing loss of benefit or toxicity during the initial stage may become eligible for a second stage involving different treatment combinations introduced via protocol amendments. Throughout the study, participants undergo regular assessments including radiographic and biochemical evaluations, biopsy when possible, and clinical status monitoring. The primary outcome is the objective response rate from randomization until disease progression or loss of clinical benefit, observed for up to 7 to 9 years. Secondary outcomes include progression-free survival, overall survival, duration of response, disease control, and the frequency of adverse events over the study period. The trial is sponsored by Hoffmann-La Roche and involves long-term monitoring until study completion in 2027.

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 evaluating sacituzumab tirumotecan alone and in combination with pembrolizumab compared to treatment chosen by the physician in participants with hormone receptor positivehuman epidermal growth factor receptor-2 negative HRHER2- breast cancer that is locally advanced, unresectable, or metastatic. The study aims to see if these treatments improve progression-free survival compared to standard physician-chosen therapies. This is a Phase 3 clinical trial assessing advanced breast cancer treatments. Participants are randomly assigned to one of three groups sacituzumab tirumotecan alone given by intravenous infusion every two weeks until disease progression or discontinuation sacituzumab tirumotecan plus pembrolizumab with sacituzumab tirumotecan given every two weeks and pembrolizumab given every six weeks for up to about two years or treatment chosen by the physician, which may include various chemotherapy options such as paclitaxel, nab-paclitaxel, capecitabine, or liposomal doxorubicin, administered with schedules depending on the drug. Treatments continue until disease progression or discontinuation. During the study, participants will have regular assessments including imaging to evaluate progression-free survival, overall survival, response rates, and quality of life measures using questionnaires. Safety is monitored by tracking adverse events and treatment discontinuations. The primary outcome is measured up to approximately 38 months, with additional secondary outcomes followed up to about 77 months. Participants are followed closely through study visits and evaluations throughout the trial period.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating a new combination of medicines, DSP107 and atezolizumab, compared with an existing treatment, fruquintinib, for patients with advanced microsatellite stable colorectal cancer. This Phase 2b, randomized, open-label study focuses on individuals whose cancer has progressed or who cannot tolerate standard therapies. The study aims to assess whether the new combination improves treatment outcomes and safety compared to the current treatment options. Participants are randomly assigned to one of two groups. One group receives DSP107 intravenously on Days 1, 8, and 15 of each 28-day cycle with atezolizumab given intravenously on Day 1. The other group takes fruquintinib orally once daily on Days 1 to 21 of each 28-day cycle. The study includes a screening period of up to 28 days, a treatment period lasting up to 24 cycles, a safety follow-up period of up to 90 days after the last dose, and a long-term follow-up lasting up to 5 years from randomization. During the study, participants will have medical evaluations including monitoring of cancer response, safety assessments, and tests such as ECG and blood pressure measurements. Quality of life and immune response to treatment will also be tracked. Participants maintain dosing diaries if assigned to the oral treatment group. The primary outcome is overall survival, with ongoing safety and health status follow-up conducted for several years after treatment. Total study participation duration varies based on treatment tolerability and disease progression.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

This research evaluates the combination of pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to prevent the need for surgery to remove the bladder cystectomy following standard chemotherapy that aims to shrink or eliminate the tumor. This phase II trial focuses on bladder preservation and improving survival without bladder removal in this patient group. Participants receive photon beam radiation therapy daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given intravenously on the first day of each 21-day cycle, for up to 18 cycles totaling 12 months, including the prior chemotherapy phase. Before and during treatment, patients undergo tissue collection via transurethral resection of bladder tumor TURBT, imaging scans such as CT, MRI, or PET, as well as cystoscopy and urine and blood tests. Throughout the study, patients are monitored for treatment effects, tumor recurrence, metastasis, and overall survival, with assessments of side effects and patient-reported symptoms related to gastrointestinal, urinary, and sexual function. After treatment, follow-up visits occur every 26 weeks until two years, then annually up to five years. Specimens are also collected for future research. The main outcome measured is bladder intact event-free survival within three years after registration.