Pancreas Adenocarcinoma Clinical Trial
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.
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.
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.
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