Cancer Clinical Trials

This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab [Gazyva®] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial. Read Less

The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future. Read Less

The purpose of this study is to determine the impact of pharmacists on reducing chemotherapy-related side effects by providing education before and after patients receive intravenous chemotherapy at one of Cedars-Sinai outpatient infusion centers. Participants will be interviewed via telephone within 7 business days after receiving intravenous chemotherapy from the outpatient cancer center infusion clinic. Read Less

Informed by a Community Advisory Board (CAB) and community assessments performed in the first phase of work funded through R01CA240080, this study will test a wawokiya (one who helps) health advocate (WHA)-based palliative care intervention that aims to improve the wellbeing of patients with cancer. In alignment with community guidance, patients will be allocated to an intervention arm or a waitlist arm as dictated by capacity. For those patients receiving the intervention, palliative care trained WHAs will perform regular home visits to assess the needs of patients seriously ill with cancer (as defined by a referring provider) and their caregivers, and work to address those needs using their training and identified community resources. The frequency of visits / calls will be determined based on level of need. The specific aims are listed below. Specific Aim 1: To examine the impact of a wawokiya health advocate (WHA) palliative care intervention on patient health outcomes including quality of life, symptom burden, and psychosocial wellbeing. H1: Compared to patients in the waitlist group, patients enrolled in the WHA intervention will have a better quality of life, greater psychosocial wellbeing, and lower symptom burden. Specific Aim 2: To assess the impact of a WHA palliative care intervention on patient healthcare utilization including emergency room visits, hospitalizations, telehealth visits, and concordance of services with goals of care. H2: Patients enrolled in the WHA intervention will have fewer ER visits and hospitalizations and a greater number of telehealth visits than patients enrolled in the waitlist group. H3: A greater proportion of patients enrolled in the WHA intervention will die in their preferred location. Specific Aim 3: To examine the impact of a WHA palliative care intervention on caregiver outcomes including coping, caregiver burden, and quality of life. H4: Compared to caregivers in the waitlist group, caregivers enrolled in the WHA intervention will have a better quality of life, better coping, and decreased caregiver burden. Specific Aim 4: To explore moderators and mediators of a WHA as a palliative care navigator on rural reservations in South Dakota. H5: Adherence to protocols will moderate the effectiveness of a WHA as a PC navigator. . Read Less

This is a prospective, open-label navigational investigation designed to evaluate the feasibility of using molecular profile-based evidence to determine individualized cancer therapy for patients with aggressive malignancies. This is a non-randomized, histology-agnostic trial. Although there will be a case mix of histologies, the investigators now know that individual histologies are composed of a heterogeneous mix of molecular alterations. It is not clear whether one case mix is better or worse than another. Thus, the investigators are testing a strategy of molecular matching that may apply across different cancers. Read Less

The goal of this clinical trial is to test the safety and efficacy of KVA12123 alone or combined with pembrolizumab in patients with advanced solid tumors. The main questions this study aims to answer are: What is the safety of KVA12123 when administered alone and in combination with pembrolizumab to advanced cancer patients? What is an appropriate dose of KVA12123 to administer alone and in combination with pembrolizumab to advanced cancer patients in future clinical trials? Participants in this trial will be asked to: Visit the clinical site every 1 - 2 weeks. Receive KVA12123 every 2 weeks alone or in combination with pembrolizumab every 6 weeks. Provide blood samples to evaluate drug levels in blood, drug safety and to explore the effects of each drug on the immune system. Undergo scans every 6 weeks to test the effect of treatment on cancer progression. Undergo other study procedures to evaluate drug safety and participant safety including physical exams, heart function tests, etc. Read Less

This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose. In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed. In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS < 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals. The majority of participants will have no prior exposure to psilocybin or so-called "magic mushrooms"; however, participants with prior recreational experience with psilocybin or "magic mushrooms" are eligible. Read Less

The Ezra Faster Scan study uses non-invasive magnetic resonance imaging (MRI) technology that can "visually" detect early and late-stage cancer, and other pathologies. MRIs use a magnetic field and radio waves to create a 3-dimensional (3D) image of an individual's body without using ionizing radiation. The purpose of this research is to decrease the amount of time required by an individual to complete an early cancer screening comprehensive magnetic resonance imaging (MRI) scan, such as the Ezra Full Body MRI imaging scan. If the time required to conduct a comprehensive scan is reduced, the cost of the scan may also decrease. By decreasing consumer costs and time, more individuals may be able to afford MRI-based early cancer screening technology. Participants in this study will undergo a minimum 30-minute MRI session. These sessions will be used to evaluate new MRI "instructions" that allow for a faster MRI scan time. The images will also be used to develop mathematical models or machine learning tools that allow images to be enhanced. By enhancing images using machine learning, they may be restored to a quality typically observed in MRI sessions with longer scan (acquisition) times. To read more about the study, potential participants may review the informed consent form located below in the References section. Potential participants may email research.fasterscan@ezra.com, or call 516.340.1221. See study Eligibility Criteria below. Read Less

This proposal aims to leverage ongoing community outreach efforts and the Cancer Center's aims to improve recruitment to clinical trials by educating the catchment and making referrals to engage current UCCC patients not taking advantage of available CTs at this institution and affiliated hospitals. The Cancer Prevention and Control Program within UCCC works to develop and evaluate novel approaches to primary prevention, disseminate preventative interventions in population-based settings, and to improve health services delivery and outcomes for cancer patients and survivors. A primary emphasis is placed on those from underrepresented populations, including Hispanics, residents of outlying rural areas, and those in areas of poverty. Efforts to meet the Cancer Center's priorities include interventions to promote awareness and recruitment of eligible patients to available CTs in the catchment area (the state of Colorado). Read Less

LVGN7409 is a humanized monoclonal antibody that specifically binds to CD40, and acts as an agonist against CD40. This first in human study of LVGN7409 is designed to establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended Phase 2 dose(s) (RP2D) of LVGN7409, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody and/or CD137 agonist in the treatment of advanced or metastatic malignancy. Read Less

The study is an observational trial for patients undergoing cancer-related interventions and therapy at Medical College of Wisconsin Cancer Center. Projects under this protocol will use patient data that will be collected both retrospectively and prospectively. It will also enable prospective sample collection for specific cancer-related studies. Read Less

This study evaluates whether a "Patient Navigation 2.0 Checklist" intervention is effective in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations. Read Less