Patient Clinical Trials

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747-302

Topic of Study: Gastrointestinal Disease
Sponsor: Intercept
Principal Investigator: Paul J. Thuluvath, M.D., FRCP, 410-332-9356
Research Coordinator: Olivia Tang, 410-843-2069
For More Information: otang@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

This study is a phase 4 trial evaluating the effect of obeticholic acid on clinical outcomes in patients with primary biliary cholangitis. (302)

 

A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, M.D. 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

The primary aim of the study is to determine whether the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread differs from a healthy, age-matched cohort of the American population. This is a collaborative study with the University of California, San Diego and Rob Knight, PhD who will perform the genetic analysis of bio-specimens from patients who undergo cytoreductive surgery with HIPEC. (Clinical Trials ID #: NCT02599116) 

AURORA

Topic of Study: Gastrointestinal Disease
Sponsor: Tobira Therapeutics
Principal Investigator: Paul Thuluvath, M.D., FRCP, 410-332-9356
Research Coordinator: Sung Cho, 410-576-5389
For More Information: scho@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

This study is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cenicriviroc for the treatment of liver fibrosis in adult subjects with nonalcoholic steatohepatitis. (AURORA)

B-57/ AFT-05, ABCSG 42, BIG 14-03 “PALLAS”

Topic of Study: Breast Cancer
Sponsor: Alliance Foundation Trials
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

The purpose of this study is to compare 2 years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alone in patients with hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. (Clinicaltrials.gov ID#: NCT02513394)

BIG 16-05/AFT-27/WO39391

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a research study comparing Atezolizumab (Anti-PD-L1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triplenegative breast cancer. (Clinicaltrials.gov ID#: NCT03498716)

BWEL

Topic of Study: Breast Cancer
Sponsor: Alliance for Clinical Trials in Oncology
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). This study will help to show whether weight loss programs should be a part of breast cancer treatment. (Clinicaltrials.gov ID#: NCT02750826)

BYLIEVE

Topic of Study: Breast Cancer
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase II randomized trial evaluate the efficacy and Safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR) positive, HER2- negative advanced breast cancer (aBC), who have progressed on or after CDK 4/6 inhibitor treatment. (Clinicaltrials.gov ID#: NCT03056755)

C1171002

Topic of Study: Gastrointestinal Disease
Sponsor: Pfizer
Principal Investigator: Paul J. Thuluvath, M.D., FRCP, 410-332-9356
Research Coordinator: Olivia Tang, 410-843-2069
For More Information: 410-332-9356
Coordinated Through: The Institute for Digestive Health and Liver Disease

This study is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate safety, tolerability, and pharmacodynamics of PF 05221304 administered daily for 16-weeks to adult subjects with non-alcoholic fatty liver disease.

CB8025-21629

Topic of Study: Gastrointestinal Disease
Sponsor: Cymabay
Principal Investigator: Paul J. Thuluvath, M.D., FRCP, 410-332-9356
Research Coordinator: Olivia Tang, 410-843-2069
For More Information: otang@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

This study is a phase 2, open label, randomized trial evaluating the effect and safety of MBX-8025 on clinical outcomes in patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid (UDCA). 

CO40016

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a double-blind, placebo-controlled, randomized phase III study of ipatasertib in combination with paclitaxel as a treatment for patients with PIK3CA/AKT1/PTEN-altered, locally advanced or metastatic, triple-negative breast cancer or hormone receptor–positive, HER2-negative breast cancer  (Clinicaltrials.gov ID#: NCT03337724).

CONCERTO

Topic of Study: Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor: AstraZeneca
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9200
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a single arm, open-label, Phase IIB study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in women with recurrent platinum resistant epithelial ovarian cancer, including fallopian tube and/or primary peritoneal cancer who do not carry a deleterious or suspected deleterious germline BRCA mutation. (Clinicaltrials.gov ID#: NCT02889900)

The Confirm Study

Topic of Study: Gastrointestinal Disease
Sponsor: Mallinckrodt Pharmaceuticals
Principal Investigator: Paul Thuluvath, M.D., FRCP, 410-332-9356
Research Coordinator: Sung Cho, 410-576-5389
For More Information: fessando@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

A multi-center, randomized, placebo-controlled, double-blind study to confirm the efficacy and safety of terlipressin in subjects with hepatorenal syndrome type I. (The Confirm Study) (MNK19013058)

EMMINENCE

Topic of Study: Gastrointestinal Disease
Sponsor: Cirius Therapeutics
Principal Investigator: Anurag Maheshwari, M.D., 410-332-9356
Research Coordinator: Sung Cho, 410-576-5389
For More Information: scho@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

This study is a phase 2, randomized, double-blind, placebo-controlled, 12-month, multiple-dose study to evaluate the safety, tolerability and efficacy of three dose levels of MSDC-0602K in patients with NASH. (EMMINENCE™)

EA1131

Topic of Study: Breast Cancer
Sponsor: ECOG ACRIN Cancer Research Group
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase III trial to determine how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with triple-negative breast cancer who have residual disease following neoadjuvant chemotherapy and surgery. (Clinicaltrials.gov ID#: NCT02445391)

EVA-21335

Topic of Study: Multiple Myeloma
Sponsor: Evidera
Principal Investigator: Sandy Kotiah, M.D., 410-783-5858
Research Coordinator: Andrea Gerbasio-Stephenson, 410-951-7908; Lisa McConnell, RN, 410-332-1200
Coordinated Through: Institutional Research

This study involves a 1 hour telephone interview to gather information about Smouldering and Multiple Myeloma from a patient’s perspective.

A Single Arm Prospective Multicenter Study Evaluating the Biodesign® Plastic Surgery Matrix

Topic of Study: Breast Cancer
Sponsor: Cook Biotech Incorporated
Principal Investigator: Brendan J. Collins, M.D., 401-332-9700
Research Coordinator: Irene van Gaalen, PA-C, 410-332-5488
For More Information: 410-951-7950
Coordinated Through: The Breast Reconstruction and Restoration Center at Mercy

This study is designed for patients desiring nipple reconstruction following surgery for breast cancer and breast reconstruction. Eligible patients will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK® Biodesign® Plastic Surgery Matrix. The study is designed to evaluate the benefit of this device in achieving effective and aesthetic nipple reconstruction. Patients will be evaluated at the time of the procedure and at 1 week, 4 weeks, 3 months, 6 months, and 12 months after surgery to examine the projection of their reconstructed nipple(s) and patient satisfaction (Cook Medical Study 09-009; Clinicaltrials.gov ID#: NCT01216319).

FLEX

Topic of Study: Breast Cancer
Sponsor: Agendia
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome information to look at the Agendia Breast Cancer suite and new gene associations. The Agendia Breast Cancer Suite includes MammaPrint® and BluePrint™, which are tests that help your doctor analyze and profile your breast cancer tumor. DiscoverPrint is for research purposes only. (Clinicaltrials.gov ID#: NCT03053193)

Insulin

Topic of Study: Breast Cancer
Sponsor: Mt Sinai NY
Principal Investigator: Neil B. Friedman, M.D., 410-332-9330
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459 and Andrea Gerbasio CRA, 410-951-7908
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This study is researching the link between insulin resistance and breast cancer prognosis in African American and Caucasian women.

JX594-HEP024

Topic of Study: Gastrointestinal Disease
Sponsor: SillaJen
Principal Investigator: Paul J. Thuluvath, M.D. FRCP, 410-332-9356
Research Coordinator: Sung Cho, 410-576-5389
For More Information: 410-576-5389
Coordinated Through: The Institute for Digestive Health and Liver Disease

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

NRG BR-003

Topic of Study: Breast Cancer
Sponsor: NRG Oncology
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. (Clinicaltrials.gov ID#:NCT02488967)

Observational Study to Define the Microbiologic and Immune Characteristics of Peritoneal Tissues in Patients with Appendiceal Cancer with Peritoneal Spread

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, MD, FACS, 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-783-5828
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

The primary aim of the study is to determine the microbiological environment of the peritoneal tissues of patients undergoing cytoreductive surgery with intraoperative hyperthermic chemotherapy for appendix cancer with peritoneal spread.

Olympia (B-55)

Topic of Study: Breast Cancer
Sponsor: NRG Oncology
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This trial compares olaparib versus placebo as adjuvant treatment in patients with BRCA1 or BRCA2 mutations and triple negative breast cancer (ClinicalTrials.gov ID#: NCT02032823)

Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

Topic of Study: Gynecologic Cancer
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250, Armando Sardi, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9329 or 410-332-9294
Coordinated Through: The Gynecologic Oncology Center at Mercy and Surgical Oncology at Mercy

The purpose of this phase II trial is to determine the toxicity and post-operative complications related to cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) as an initial treatment option for patients with ovarian, fallopian tube, or primary peritoneal cancers and its impact on quality of life.  Subjects will be randomized to one of two treatment groups: CRS with HIPEC followed by combination chemotherapy, carboplatin and paclitaxel, or CRS only followed by combination chemotherapy carboplatin and paclitaxel.

Protocol Title and ClinicalTrials ID#: A phase II randomized study: Outcomes after cytoreductive surgery (CRS) with or without carboplatin hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic chemotherapy with carboplatin and paclitaxel as initial treatment of ovarian, fallopian tube, and primary peritoneal cancer. NCT02124421

Development of Patient-derived Tumorgrafts as a Model for the Discovery of Biomarkers and Therapeutic Approaches for Gynecological Tumors

Topic of Study: Gynecologic Cancer
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250
Research Coordinator: Michelle Sittig, RN or Angie Gahres, BSN, RN at 410-332-9294
For More Information: 410-332-9294
Coordinated Through: The Gynecologic Oncology Center at Mercy and Johns Hopkins University, Oncology - Cancer Prevention and Control

The objective of this study is to collect patient specimens prospectively (tumor, blood, vaginal swab, and urine sample) from benign, high risk, and malignant surgeries in order to develop diagnostic biomarkers and targeted anticancer agents for gynecologic tumors. http://lifegenedna.com/

Clinical Trial to Define the Effect of Perioperative H. Pylori Eradication with Antibiotic Treatment on the Long Term Outcomes of Patients with Pseudomyxoma Peritonei of appendiceal origin undergoing Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy (CRS/HIPEC)

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

This study is a phase II, open label, historical controlled study to determine the impact of antibiotic therapy on the disease progression and overall survival of the patients with Pseudomyxoma Peritonei (PMP). The study will examine the use of the antibiotic PREVPAC, in patients undergoing CRS/HIPEC for appendiceal neoplasms with peritoneal dissemination and its effect on patient outcomes and survival. (ClinicalTrials.gov ID#: NCT02387203)


A Study of Histo-Pathological Staging and Classification Guidelines for Appendiceal Carcinomatosis

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, M.D. 410-332-9294, Kimberley Studeman, M.D. 410-332-9447
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

This is a study to define the pathological staging for appendiceal neoplasms by examining mutations of the genetic makeup of tumor tissue and to analyze prognostic factors associated with various stages of appendiceal cancer with peritoneal dissemination.  


POLARIS

Topic of Study: Breast Cancer
Sponsor: Pfizer
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a non-interventional trial for patients receiving palbociclib for their hormone positive advanced breast cancer.  (Clinicaltrials.gov ID#: NCT03280303)

 

SEMA-NASH

Topic of Study: Gastrointestinal Disease
Sponsor: Novo Nordisk
Principal Investigator: Anurag Maheshwari, M.D., 410-332-9356
Research Coordinator: Sung Cho, 410-576-5389
For More Information: scho@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis. A 72-week randomized, double-blind, placebo-controlled, six-armed parallel group, multi-center, multinational trial.

Sophia

Topic of Study: Breast Cancer
Sponsor: Macrogenics
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This trial compares olaparib versus placebo as adjuvant treatment in patients with BRCA1 or BRCA2 mutations and triple negative breast cancer (ClinicalTrials.gov ID#: NCT02032823)

SWOG S1207

Topic of Study: Breast Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This randomized phase III trial is studying how well giving hormone therapy together with or without everolimus works in treating patients with high-risk, hormone receptor-positive, HER2-negative breast cancer. (ClinicalTrials.gov ID#: NCT01674140)

SWOG S1418

Topic of Study: Breast Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase III randomized trial evaluate the efficacy and safety of pembrolizumab for women with triple-negative breast cancer who have residual invasive cancer or positive lymph nodes after neoadjuvant chemotherapy. (Clinicaltrials.gov ID#: NCT02954874)

TARGIT-US

Topic of Study: Breast Cancer
Sponsor: University of California San Francisco
Principal Investigator: Neil B. Friedman, MD, 410-332-9330
Study Coordinator: Andrea Gerbasio, 410-951-7908
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This is an observational study for women who are receiving Intraoperative Radiation Therapy (IORT) following breast-conserving surgery. (ClinicalTrials.gov ID#: NCT01570998)

Hyperthermic Intraoperative Intraperitoneal Chemotherapy for Intra-abdominally Advanced Colorectal, Appendix, Gastric, Small Bowel, Primary Peritoneal, Ovarian Cancers, Peritoneal Mesothelioma, and Sarcomas

Topic of Study: Other
Principal Investigator: Armando Sardi, M.D. and Vadim Gushchin, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

This study involves storing specimens from CRS/HIPEC patients with advanced colorectal, gastric, small bowel, primary peritoneal, ovarian cancers, peritoneal mesothelioma, and sarcomas. The purpose is to collect, maintain, and store tissues specimens from CRS/HIPEC and clinical data for future research. The collection of clinical data and outcomes from CRS/HIPEC for advanced intra-abdominal cancers will be used to refine future treatment protocols and enhance patient care.

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