Clinical Trials Using Pegylated Recombinant Human Hyaluronidase PH20
Clinical trials are research studies that involve people. The clinical trials on this list are studying Pegylated Recombinant Human Hyaluronidase PH20. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
A Phase Ib / II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
Location: 12 locations
Gemcitabine Hydrochloride, Nab-Paclitaxel, PEGPH20, and Rivaroxaban in Treating Patients with Stage III-IV Pancreatic Cancer That Cannot Be Removed by Surgery
This pilot phase II trial studies the side effects and how well gemcitabine hydrochloride, nab-paclitaxel, pegylated recombinant human hyaluronidase PH20 (PEGPH20), and rivaroxaban work in treating patients with stage III-IV pancreatic cancer that has spread to other places in the body (metastatic) and cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PEGPH20 may stop the growth of tumor cells by breaking down hyaluronan, a tissue component needed for cell growth. However, PEGPH20 is also associated with an increased risk for blood clots. Rivaroxaban is a blood thinner that may help prevent blood clots. Giving gemcitabine hydrochloride, nab-paclitaxel, PEGPH20, and rivaroxaban together may work better in treating pancreatic cancer.
Location: 10 locations
A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G / GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
A Phase Ib / II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G / GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.
Location: 6 locations
Atezolizumab with or without PEGPH20 before and after Surgery for the Treatment of Stage I-II Resectable Pancreatic Cancer
This phase II trial studies how well atezolizumab with or without PEGPH20 given before and after surgery works in treating patients with stage I-II pancreatic cancer that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PEGPH20 may stop the growth of tumor cells by breaking down hyaluronan, a tissue component needed for cell growth. Giving atezolizumab with PEGPH20 before and after surgery may increase immune response compared to atezolizumab alone.
Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York
Second-line Study of PEGPH20 and Pembro for HA High Metastatic PDAC
This study is the study of the combination of PEGPH20 and Pembrolizumab (MK-3475) for patients with previously treated Hyaluronan High (HA-high) metastatic pancreatic ductal adenocarcinoma. This study is an interventional, unblinded, open label study. Approximately 35 subjects will be enrolled. The trial will require approximately a total of 18 months, including 12 months for enrollment, with an additional 6 months for patient follow-up, data collection and study closure. Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final contact. After a screening phase of up to 21 days, eligible subjects will receive PEGPH20 beginning with Cycle 1 Day 1, on Days 1, 8 15 of every 3 week-cycles and pembrolizumab beginning on Cycle 1 Day 1 (2-4 hrs after PEGPH20), every 3-week-cycles. Treatment with PEGPH20 and pembrolizumab will continue until progressive disease (PD), unacceptable adverse events (AEs), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, subject receives 35 treatments (approximately 24 months) of pembrolizumab, or administrative reasons requiring cessation of treatment. Subjects who discontinue for reasons other than PD will have post-treatment follow-up for disease status until PD, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival (OS) until death, withdrawal of consent, or the end of the study. After the end of treatment, each subject will be followed for 30 days for AE monitoring. Serious adverse events (SAE) and events of clinical interest (ECI) will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier.
Location: See Clinical Trials.gov