Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Pilot Study to Assess the Efficacy and Safety Effects of Pembrolizumab and PEGPH20 (Pegvorhyaluronidase Alfa) in Patients With Metastatic Pancreatic Cancer
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01964287 -
First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.
|
Phase 1/Phase 2 | |
| Completed |
NCT02826486 -
Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202)
|
Phase 2 | |
| Active, not recruiting |
NCT04524702 -
Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02890355 -
FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04652206 -
Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04132505 -
Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT00998322 -
A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT04514497 -
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT02562898 -
Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05642962 -
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
|
Phase 1/Phase 2 | |
| Completed |
NCT01896869 -
FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03337087 -
Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02677038 -
Olaparib in Treating Patients With Stage IV Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02985125 -
LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05383352 -
A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas
|
Phase 1 | |
| Completed |
NCT03943667 -
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
|
Phase 3 | |
| Completed |
NCT02436668 -
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
|
Phase 3 | |
| Completed |
NCT01360853 -
Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer
|
Phase 3 | |
| Completed |
NCT01124786 -
A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
|
Phase 2 |