Gastroenterology and Hepatology

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in combination with pembrolizumab, carboplatin, and pemetrexed), A2 (SAR444881 in combination with pembrolizumab), B1 (SAR444881 in combination with pembrolizumab and later therapy), and C1 (SAR444881 in combination with cetuximab and later therapy), as well as Sub-Part 2B (Dose Expansion) with Cohort D1 (monotherapy SAR444881).

2. A Study to Evaluate the Effectiveness and Safety of PRV-015 in Adult Patients wth Non-responsive Celiac Disease as an Adjunct to a Gluten-free Diet

   Rochester, Minn.

   The purpose of this study is to evaluate the effectiveness and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

3. A Study to Evaluate the Effect of Improving Glycemic Control on Gastric Emptying in Type 1 and Type 2 Diabetes Mellitus

   Rochester, Minn.

   The purpose of this study is to evaluate the effects of improving glycemic control, and/or reducing glycemic variability on gastric emptying, intestinal barrier function, autonomic nerve functions, and epigenetic changes in subjects with type 1 diabetes mellitus (T1DM) and  type 2 diabetes mellitus (T2DM) who are switched to intensive insulin therapy as part of clinical practice.

4. A Study to Create a Registry for Patients at High-Risk for Pancreatic Cancer

   Rochester, Minn.

   This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC). and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.

5. A Study to Evaluate if New Tests (“biomarkers”) of Blood, Stool, Pancreas Cyst Fluid, or Pancreas Juice can be Used to Diagnose Malignant or Pre-malignant Changes in People with Pancreas Cysts

   Rochester, Minn.

   The goal of this protocol is to collect biospecimens in order to prospectively evaluate diagnostic and prognostic performance of MDMs for detection of advanced neoplasia in pancreatic cysts. 

6. A Study to Evaluate the Use of Confocal Laser Endomicroscopy as an IMaging Biomarker (CLIMB Study) for the Diagnosis of Pancreatic Cystic Lesions

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate EUS-nCLE as an imaging biomarker and PCL fluid DNA analysis as a molecular biomarker for the management of pancreatic cystic lesions (PCLs).

7. A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to compare the effectiveness of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.

8. A Study To Examine Quality of Life Assessment in Patients Receiving Cryotherapy for Palliation of Dysphagia in Unresectable Esophageal or Gastroesophageal Junctional Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the effect of endoscopic cryoablation for lessening the effects of dysphagia on the quality of life (QOL) of patients with unresectable esophageal or gastroesophageal junctional cancer.

9. Obesity Treatment Outcomes in Liver Transplant Recipients

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to prospectively evaluate the safety and effectiveness of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing liver transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.

10. A Study to Evaluate the Safety, Tolerability, and Determine the Optimal Dose for the Expansion Cohorts of VSV-IFNβ-NIS in Combination with Pembrolizumab in Patients with Refractory Solid Tumors

    Rochester, Minn.

    The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).