Spots Global Cancer Trial Database for The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.
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Trial Identification
Brief Title: The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.
Official Title: A Single Arm Phase 2 Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.
Study ID: NCT04045730
Conditions
Interventions
Study Description
Brief Summary: This is an open-label single arm phase 2 study for patients with metastatic pancreatic ductal adenocarcinoma who have not received any prior systemic therapies.
Detailed Description: To determine the efficacy of gemcitabine plus nab-paclitaxel in combination with PVHA and pembrolizumab as measured by progression free survival (PFS). Hypothesis: The combination of gemcitabine, nab-paclitaxel, PVHA and pembrolizumab will improve PFS compared to the historical control for chemotherapy. 3.2 Secondary Objectives \& Hypotheses 1. Objective: To estimate median overall survival (OS) 2. Objective: To determine the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 3. Objective: To determine the toxicity and tolerability of gemcitabine plus nab-paclitaxel with PVHA and pembrolizumab. Hypothesis: The combination of gemcitabine, nab-paclitaxel, PVHA, and pembrolizumab will be safe and improve OS and ORR compared to the historical control for chemotherapy. 3.3 Exploratory Objective 1. Objective: To evaluate pre-treatment and on-treatment PD-L1 and hyaluronan (HA) status and correlate with PFS, ORR, and OS. 2. Objective: To measure the stromal alterations and stromal degradation of hyaluronan and correlate with clinical benefit. 3. Objective: To quantify the pre-treatment and on-treatment change in immune effector cells and correlate with clinical benefit. 4. Objective: To cryopreserve additional tumor tissue for future analysis, including but not limited to DNA and RNA sequencing. 5. Objective: To create organoid cultures from core biopsy specimens for future studies.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Michael Cecchin, MD
Affiliation: Yale University
Role: PRINCIPAL_INVESTIGATOR
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