Cancer Clinical Trials in Pittsburgh, PA

Epithelial ovarian cancer (OC) is the most lethal gynecologic cancer: nearly 22,000 women are diagnosed with OC in the US annually and 63% are expected to die from their disease. The 5-year overall survival rate is unacceptably low at 20-30%, with \> 50% of patients experiencing recurrence of their disease. Recurrent, platinum-resistant OC is characterized by a low response to chemotherapy (\<10-15%) and poor prognosis, with overall survival estimated to be \<12 months. Thus, there is an urgent need to identify novel therapies to improve outcomes for patients with recurrent, platinum resistant OC. The primary focus in this trial is targeting tumor associated immunosuppressive T-regs with E7777 combined with PD-1 inhibitor, pembrolizumab. This trial will enroll patients with solid tumors in the dose escalation portion and specified cohorts in the dose expansion portion. In the Phase I portion, 18-30 patients will be enrolled. In the dose expansion portion, approximately 40 patients (20 in each cohort) will be enrolled. Given the relatively poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates. Read Less

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Read Less

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive. Read Less

One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM) has the potential to significantly reduce biopsy rates for commonly seen benign breast lesions while preserving very high cancer detection. The investigators propose a prospective clinical study of patients with diagnostic mammograms rated as BIRADS 4A or 4B and scheduled for a biopsy, in which, prior to undergoing their scheduled biopsy, a CEM procedure is performed. The investigators will test the primary hypothesis that for soft tissue lesions (i.e. masses, asymmetries, architectural distortions) initially rated BI-RADS 4A/4B adding CEM will reduce, by at least 20%, the number of biopsy recommendations for actually benign cases and, at the same time, provide a negative predictive value (NPV) higher than 95%. Read Less

The current study is a case control study involving comparisons of tissue interstitial fluid from breast cancer and adjacent non-cancerous tissue as well as that from benign breast lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The purpose of this research is to collect fresh breast nodule/cancer and surrounding non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile distinguishing breast cancer which will also permit future research on stored interstitial fluid, blood or tissue samples. Specific markers identified from interstitial fluid study will be investigated in blood samples to develop serum markers for breast cancer diagnosis and prognosis. Additionally, we will perform both prospective and retrospective research on breast cancer involving clinical, demographic, epidemiologic information, treatment, follow-up and outcomes on breast nodule/cancer cases collected. Read Less

This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expressed in many cancer cells and is involved in cellular repair. Read Less

This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer. Read Less

After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Some participants may also be asked to provide a urine sample. Individuals undergoing procedures that require collection of biological samples for clinical purposes may have these samples saved for research purposes. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects. Read Less

All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized. Read Less

The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with NKTR-255 and anti-PD1 therapy for subjects with refractory non-small cell lung cancer. The purpose of this study is to: 1. Test the safety and ability for subjects to tolerate the TIL therapy 2. Measure to see how the NSCLC responds to the TIL therapy Participants will be asked to: * Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051. * Receive standard of care treatment until their lung cancer no longer responds * When necessary, the C-TIL051 will be manufactured by the sponsor and sent back to the site * Subject will then receive chemotherapy (called lymphodepletion) for 3 days followed by 2 days of rest * C-TIL051 will then be infused on day 0 followed by NKTR-255 (IL-15) about 12 to 24 hours later * Pembrolizumab will be administered every 3 weeks for up to 2 years NKTR-255 is a novel polymer-conjugated human IL-15 receptor agonist molecule designed to increase the proliferation and survival of memory CD8+ T cells and enhance the formation of long-term immunological memory which may lead to sustained anti-cancer immune response. The combination of NKTR 255 and TIL's could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity. Read Less

This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia. Read Less

Cancer is amongst the leading causes of disease-related morbidity and mortality. A major challenge in cancer treatment is the development of biology-informed, personalised treatment strategies. Recent advances in artificial intelligence (AI) and next-generation sequencing (NGS) technologies have shed further insights into disease biology and treatment pathways, thus identifying new, precision medicine-based therapeutic opportunities. The biological mechanisms leading to cancer development and progression arise from complex and plastic networks of dysregulated cellular programs involving many signalling pathways and effector molecules. Cancer cells alter their surrounding environment via cell-cell interactions with non-tumor cells or by secreting cytokines, chemokines and other factors. This reprogramming of the tumour microenvironment (TME) is critical for cancer progression, invasion, and metastasis. Moreover, there are increasing studies that show that both innate and adaptive immune cell types contribute to tumorigenesis and treatment resistance when present within the TME. Understanding the crosstalk between cancer cells and the surrounding TME will inform on mechanisms of sensitivity and resistance to treatment, including immunotherapy (IO) and targeted therapies. Spatially resolved-Omics is an emerging field that characterises cell types by gene/protein expressions within their spatial context in the tissue organisation. Recent high profile spatial transcriptomics studies have uncovered specific cell identities that define the surrounding TME. The MOSAIC study, a collaborative initiative across industry and top oncology hospitals, proposes to go way beyond current cancer molecular profiling projects by combining the generation and analysis of multiple data modalities (3 essential mandatory modalities: Clinical Data, Hematoxylin and Eosin (H\&E) microscopic image, Spatial transcriptomics; up to 3 high priority data modalities depending on technical feasibility and sample size: bulk Ribonucleic Acid Sequencing (RNAseq), bulk Whole Exome Sequencing (WES), Single-cell transcriptomics; and potentially other optional data modalities and follow-up experiments such as single-cell omics, immunohistochemistry and spatial proteomics or other molecular profiling of proteins and molecules) on a minimum of 2,000 tumour samples across a different cancer indications. This will generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients, integrated with clinical data, at an unprecedented scale and resolution. This study will enroll patients diagnosed with one of the eligible cancer indications and for which a formalin fixed paraffin embedded (FFPE) tumor sample from already performed biopsy and/or surgical resection is available within their local pathology archive or their affiliate centers archives. The MOSAIC study expects to have a strong impact for patients in terms of new targeted therapeutic drug discovery, identification of patient subgroups requiring either specific treatment or broader clinical care and identification of novel treatment response and resistance mechanisms. Read Less