Description:
The purpose of this clinical trial is to study an experimental drug called pembrolizumab or
MK-3475 for use in combination with chemotherapy and radiation therapy for patients with
resectable (surgical removal) or borderline resectable pancreatic cancer. In general,
pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy
and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery
might be possible. However, this is not always effective at shrinking the tumor enough to
allow it to be removed with surgery. Recent discoveries suggest that the investigators own
immune system might have a role in controlling the growth of tumors. Drugs such as
pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to
investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can
improve the body's immune response against pancreatic cancer.
Pembrolizumab has been approved for treatment of patients with melanoma but has not been
proven to be safe or helpful in patients with pancreatic cancer and is not approved by the
U.S. Food and Drug Administration (FDA) for this purpose.
Title
- Brief Title: Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
- Official Title: A Randomized Multicenter Ib/II Study to Assess the Safety & Immunological Effect of Chemoradiation Therapy in Combination With Pembrolizumab Compared to CRT Alone Resectable/Borderline Resectable Pancreatic Cancer
Clinical Trial IDs
- ORG STUDY ID:
17801
- NCT ID:
NCT02305186
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | MK-3475, Keytruda | Neodjuvant CRT + Pembrolizumab |
Purpose
The purpose of this clinical trial is to study an experimental drug called pembrolizumab or
MK-3475 for use in combination with chemotherapy and radiation therapy for patients with
resectable (surgical removal) or borderline resectable pancreatic cancer. In general,
pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy
and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery
might be possible. However, this is not always effective at shrinking the tumor enough to
allow it to be removed with surgery. Recent discoveries suggest that the investigators own
immune system might have a role in controlling the growth of tumors. Drugs such as
pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to
investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can
improve the body's immune response against pancreatic cancer.
Pembrolizumab has been approved for treatment of patients with melanoma but has not been
proven to be safe or helpful in patients with pancreatic cancer and is not approved by the
U.S. Food and Drug Administration (FDA) for this purpose.
Trial Arms
Name | Type | Description | Interventions |
---|
Neodjuvant CRT + Pembrolizumab | Experimental | Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab | |
Neoadjuvant CRT | Active Comparator | Standard neoadjuvant chemoradiation treatment (CRT) alone | |
Eligibility Criteria
Inclusion Criteria:
1. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
2. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale
3. Adequate organ function
4. In subjects requiring biliary decompression, metal stent or drainage using
percutaneous transhepatic cholangiogram (PTC) are allowed
Exclusion Criteria:
1. Immunodeficiency or taking steroid or any other form of immunosuppressive therapy
2. Has a plastic biliary stent for decompression
3. Metastatic disease
4. Prior treatment for pancreatic cancer (other than 4-8 cycles of Folfirinox) or prior
treatment with radiation for other diagnoses to the expected pancreatic cancer
treatment area
5. Active autoimmune disease
6. Pregnancy or Nursing
7. Known history of Human Immunodeficiency Virus (HIV) or Hepatitis B or C
8. Prior monoclonal antibody within 4 weeks prior to study Day 1
9. Known additional malignancy that is progressing or requires active treatment
10. Evidence of interstitial lung disease or active, non-infectious pneumonitis
11. Active infection requiring systemic therapy
12. Prior therapy with an anti-Program Death (PD-1) antibody, anti-PD-L1, anti-PD-L2, or
anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue). |
Time Frame: | 2-3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Disease-free survival (DFS) |
Time Frame: | 2-4 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | 2-4 years |
Safety Issue: | |
Description: | |
Measure: | Response Rate (RR) |
Time Frame: | 2-3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Craig L Slingluff, Jr |
Trial Keywords
- Immunotherapy
- Neoadjuvant
- Resectable
- Borderline resectable
Last Updated
August 13, 2021