Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381154
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-04-19
Brief Title:
Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Photodynamic Priming to Facilitate Immunologic Activity of Anti-PD1 in Patients With Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery unresectable that has spread to nearby tissue or lymph nodes locally advanced or to other places in the body metastatic Photoradiation uses light activated drugs such as verteporfin that become active when exposed to light These activated drugs may kill tumor cells Vertoporfin may also increase tumor response to immunotherapy Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Chemotherapy drugs such as modified fluorouracil leucovorin irinotecan and oxaliplatin mFOLFIRINOX work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable locally advanced or metastatic pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate overall response rate ORR per immune-mediated Response Evaluation Criteria in Solid Tumors iRECIST criteria in patients with unresectable pancreatic ductal adenocarcinoma PDAC who have failed first line treatment treated with the combination photodynamic priming PDP and pembrolizumab
SECONDARY OBJECTIVES
I To evaluate duration of response DOR per iRECIST criteria in patients treated with the combination of PDP and pembrolizumab
II To evaluate progression-free survival PFS per iRECIST criteria in patients treated with the combination of PDP and pembrolizumab
III To evaluate overall survival OS in patients treated with the combination of PDP and pembrolizumab
IV To evaluate toxicity profile per Common Terminology Criteria for Adverse Events CTCAE version v 50 as assessed by treating clinicians of the combination of PDP and pembrolizumab
OTHER OBJECTIVES
I To evaluate the local and systemic immune response by evaluation of tumor directed cytotoxic lymphocytes within the primary and metastatic tumor sites using endoscopic ultrasound EUS guided fine needle aspiration before and after PDP
II To evaluate the biomarkers generated by the lymphocyte cytotoxicity assays using harvested lymphocytes from these sites
III To evaluate systemically circulating tumor directed cytotoxic lymphocyte sub-populations before and after PDP
IV To evaluate quality of life using Quality of Life Questionnaire-Pancreatic Cancer 26 QLQ PAN26 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLQ-C30
OUTLINE
Patients receive verteporfin intravenously IV and undergo a biopsy and intratumoral photoradiation over 60-90 minutes using EUS or computed tomography CT guidance on day 0 Patients receive pembrolizumab IV over 30 minutes on day 1 Treatment repeats every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients also receive standard of care oxaliplatin IV over 2-6 hours leucovorin IV over 15 minutes - 2 hours irinotecan IV over 90 minutes and fluorouracil IV on days 3 15 and 29 of cycle 1 only then on days 1 15 and 29 of remaining cycles Cycles repeat every 42 days for up to 6 months in the absence of disease progression or unacceptable toxicity Patients may optionally undergo lymph node biopsy on day 2 or 3 of cycle 1 Additionally patients undergo blood sample collection CT positron emission tomography PETCT and optional PETmagnetic resonance imaging MRI on study
After completion of study treatment patients are followed up at 30 and 90 days and every 3 months to progression then every 6 months for up to 3 years after registration
I To evaluate overall response rate ORR per immune-mediated Response Evaluation Criteria in Solid Tumors iRECIST criteria in patients with unresectable pancreatic ductal adenocarcinoma PDAC who have failed first line treatment treated with the combination photodynamic priming PDP and pembrolizumab
SECONDARY OBJECTIVES
I To evaluate duration of response DOR per iRECIST criteria in patients treated with the combination of PDP and pembrolizumab
II To evaluate progression-free survival PFS per iRECIST criteria in patients treated with the combination of PDP and pembrolizumab
III To evaluate overall survival OS in patients treated with the combination of PDP and pembrolizumab
IV To evaluate toxicity profile per Common Terminology Criteria for Adverse Events CTCAE version v 50 as assessed by treating clinicians of the combination of PDP and pembrolizumab
OTHER OBJECTIVES
I To evaluate the local and systemic immune response by evaluation of tumor directed cytotoxic lymphocytes within the primary and metastatic tumor sites using endoscopic ultrasound EUS guided fine needle aspiration before and after PDP
II To evaluate the biomarkers generated by the lymphocyte cytotoxicity assays using harvested lymphocytes from these sites
III To evaluate systemically circulating tumor directed cytotoxic lymphocyte sub-populations before and after PDP
IV To evaluate quality of life using Quality of Life Questionnaire-Pancreatic Cancer 26 QLQ PAN26 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLQ-C30
OUTLINE
Patients receive verteporfin intravenously IV and undergo a biopsy and intratumoral photoradiation over 60-90 minutes using EUS or computed tomography CT guidance on day 0 Patients receive pembrolizumab IV over 30 minutes on day 1 Treatment repeats every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients also receive standard of care oxaliplatin IV over 2-6 hours leucovorin IV over 15 minutes - 2 hours irinotecan IV over 90 minutes and fluorouracil IV on days 3 15 and 29 of cycle 1 only then on days 1 15 and 29 of remaining cycles Cycles repeat every 42 days for up to 6 months in the absence of disease progression or unacceptable toxicity Patients may optionally undergo lymph node biopsy on day 2 or 3 of cycle 1 Additionally patients undergo blood sample collection CT positron emission tomography PETCT and optional PETmagnetic resonance imaging MRI on study
After completion of study treatment patients are followed up at 30 and 90 days and every 3 months to progression then every 6 months for up to 3 years after registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015083 | NIH | Mayo Clinic | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2024-03078 | REGISTRY | None | None |
| 23-009036 | OTHER | None | None |
| MC230404 | OTHER | None | None |
| P01CA084203 | NIH | None | None |