NCT04045730

The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.

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.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreas Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	All patients will receive treatment with gemcitabine, nab-paclitaxel, PVHA, and pembrolizumab.

Timeline

• Start date: 2019-11-15
• Primary completion: 2019-12-31
• Completion: 2021-07-31
• First posted: 2019-08-05
• Last updated: 2020-01-09