NCT04058964

Pembrolizumab and PEGPH20 in Treating Patients With Metastatic Pancreatic Cancer

A Pilot Study to Assess the Efficacy and Safety Effects of Pembrolizumab and PEGPH20 (Pegvorhyaluronidase Alfa) in Patients With Metastatic Pancreatic Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab and PEGPH20 work in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PEGPH20 is an enzyme that breaks down hyaluronic acid coating tumor cells which may inhibit growth of tumor cells. Giving pembrolizumab and PEGPH20 may work better in treating patients with pancreatic cancer compared to pembrolizumab alone.

Detailed description

PRIMARY OBJECTIVES: I. To assess the progression free survival duration of patients treated with the combination of pegylated recombinant human hyaluronidase PH20 (PEGPH20) and pembrolizumab. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of the combination of PEGPH20 and pembrolizumab. EXPLORATORY OBJECTIVES: I. To evaluate objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) and Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria, duration of response (DOR), disease control rate (DCR), time to progression (TTP) and progression-free survival (PFS) per RECIST and iRECIST as assessed by M.D. Anderson investigators and overall survival (OS) of the combination of pembrolizumab and PEGPH20. II. To explore the association between PD-L1 expression by immunohistochemistry (IHC), shed PD-L1 level, hyaluronan (HA) levels, somatic gene expression profiling and antitumor efficacy of the combination of pembrolizumab and PEGPH20 based on RECIST 1.1 as well as OS. III. To explore the relationship between genomic variation and response to study treatment. IV. To examine the effect of pembrolizumab and PEGPH20 on immune cell infiltration into tumor. V. To explore the effect of PEGPH20 on serum HA levels, and to compare changes in serum HA with clinical efficacy. VI. To determine the impact of the combination of pembrolizumab and PEGPH20 on circulating immune cells. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 10 minutes on day 1 and pegylated recombinant human hyaluronidase PH20 subcutaneously (SC) on days 1, 8, and 15. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 9 and 12 weeks.

Conditions

• Metastatic Pancreatic Adenocarcinoma
• Stage IV Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Pegylated Recombinant Human Hyaluronidase PH20	Given SC
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2019-08-16
• Last updated: 2020-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study