May 20th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

May 20th, 2022 - Background: Breast cancer is the most common cancer in women. In the HER2+ subtype, brain metastases can occur in up to 25-40% of patients. The standard therapy for brain metastases continues to be surgery or stereotactic radiosurgery (SRS) and/or whole brain radiation therapy (WBRT). Currently, independently of localized or systemic treatment modality, once brain metastases are established, op...

May 20th, 2022 - Background: We generated an HLA-A*11:01-restricted murine T-cell receptor (mTCR) that specifically recognizes the G12V-mutated variant of KRAS (and other RAS family genes), expressed by many human cancers and constructed a single retroviral vector that contains its alpha and beta chains that confers recognition of this antigen when transduced into PBL. In co-cultures with HLA-A*11:01+ target ce...

May 20th, 2022 - Background Prostate cancer (PCa) is the second leading cause of cancer death in American men. Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy Recurrence of PCa after surgery or radiation is very common and sometimes progresses to death. Early intervention fo...

May 20th, 2022 - Background: Kaposi Sarcoma (KS) is a multicentric angioproliferative tumor, caused by Kaposi sarcoma-associated herpesvirus, that most frequently involves the skin, but may also involve lymph nodes, lungs, bone and gastrointestinal tract. It is most common in people with HIV but may also occur in patients without a diagnosis of HIV. Patients with HIV-associated KS have worse survival than HIV-i...

May 20th, 2022 - This is 2 part study: Part A and Part B. Part A of the study consists of a screening period and 3 treatment periods (midazolam alone, capivasertib alone, and midazolam + capivasertib). During Part A, the PK profile of midazolam will be determined with and without capivasertib.All participants will receive capivasertib treatment (4 days on/3 days off); however, at the Investigator's discretion, ...

May 20th, 2022 - This is a Phase III, double-blind, randomised study assessing the efficacy and safety of AZD9291 (80 mg orally, once daily) versus a standard of care (SoC) Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) (either gefitinib [250 mg orally, once daily] or erlotinib [150 mg orally, once daily]) in patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC...

May 20th, 2022 - Background: -Malignant ascites or pleural effusions are often seen in patients with solid tumor malignancies. -Malignant ascites is proinflammatory with many cytokines present and acts to promote tumor cell growth. -The cellular composition of malignant ascites consists of lymphocytes, macrophages and monocytes. -Serum monocytes and lymphocytes play a role in the native host anti-tumor immune m...

May 20th, 2022 - TTFields have demonstrated significant activity in in-vitro and NSCLC pre-clinical models, both as a single modality treatment and in combination with chemotherapies and PD-1 inhibitors. With taxanes, TTFields have been demonstrated to act synergistically, while TTFields have been shown to be additive when combined with PD-1 inhibition. In a pilot study of 42 patients with advanced NSCLC who ha...

May 20th, 2022 - Background: There is an unmet need for less toxic and more effective treatments for virus-associated malignancies. Pomalidomide induces polyfunctional T cell, NK cell, and dendritic cell activation. Pomalidomide has shown promising activity in Kaposi sarcoma, likely due in part to immune modulation. Downregulation and/or deregulation of immune surface markers by viruses can thwart immunologic t...

May 20th, 2022 - To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.

May 20th, 2022 - JNJ-78278343 is a humanized immunoglobulin (Ig)G1-based bispecific antibody designed to direct T lymphocytes (T cells) to human kallikrein 2 (hK2or KLK2) positive target tumor cells. One arm of JNJ-78278343 binds to the cluster of differentiation (CD)3 receptor complex present on T cells and the other arm binds to KLK2 present on target tumor cells leading to the activation of the T cells and T...

May 20th, 2022 - Each year, an estimated 69 million people suffer from traumatic brain injury/concussion worldwide. In most patients with concussion, symptoms improve within 3 months. However, in some persons, symptoms persist. The cause(s) of post-traumatic headache are not entirely clear, which limits treatment options. Sometimes, these headaches are caused by irritation to the greater occipital nerve, and pa...

May 20th, 2022 - Background: Graft versus host disease (GVHD) and impaired immune reconstitution are major transplant complications and barriers to improving outcomes after allogeneic hematopoietic stem cell transplantation (alloHSCT) for hematologic malignancies. GVHD is initiated when donor T-cells become alloreactive against recipient major or minor histocompatibility antigens. This process may be exacerbate...

May 20th, 2022 - Study Description: Individuals undergoing cisplatin-based chemoradiation therapy are at risk for developing significant, permanent hearing loss. The cholesterol-lowering drug atorvastatin has the potential to reduce the incidence and severity of hearing loss, as evidenced by our preclinical data in mice and our retrospective data in humans.Here we will compare hearing changes between subjects o...

May 20th, 2022 - Background: Starting in 2011, analysis of circulating cell-free DNA (cfDNA) in the blood of pregnant women began to be offered clinically as a prenatal screen for trisomies 13, 18, and 21. Owing to its superior sensitivity and positive predictive values compared to serum biochemistry and ultrasound markers, the cfDNA test became rapidly incorporated into prenatal clinical care. By 2013, however...

May 20th, 2022 - Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/gemcitabine (JNJ-17000139-AAC) product is an intravesical drug delivery system regulated as an investigational drug. T...

May 20th, 2022 - The present study design is a pilot within-subjects pre-/post-evaluation of feasibility, acceptability, and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention for primary brain tumor patients. In this study, participants will be asked to do the following things: Meet with a trained interventionist six times (biweekly) for group CBT-I sessions via Zoom, la...

May 20th, 2022 - The purpose of this study is to evaluate the efficacy of ibrutinib based on overall response rate (ORR) (partial response [PR] or better) by investigator assessment per the modified Consensus Response Criteria from the Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (NCCN 2019), in Chinese participants with relapsed or refractory waldenstrom's macroglobulinemia.

May 20th, 2022 - Background: Irinotecan is a prodrug of an inhibitor of topoisomerase 1 (active metabolite is SN-38) with known activity in sarcomas, however it has limitations including suboptimal bioavailability and systemic side effects including severe diarrhea and bone marrow suppression. Preclinical and clinical evidence has demonstrated that prolonged exposure to topoisomerase 1 inhibition produces super...