Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer

NCT ID: NCT02305186

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neodjuvant CRT + Pembrolizumab

Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment

Neoadjuvant Chemoradiation

Intervention Type: RADIATION

Chemoradiation with capecitabine (825 mg/m2 orally twice daily, Monday through Friday, on days of radiation only) and radiation (50.4 Gy in 28 fractions over 28 days)

Neoadjuvant CRT

Standard neoadjuvant chemoradiation treatment (CRT) alone

Group Type: ACTIVE_COMPARATOR

Neoadjuvant Chemoradiation

Intervention Type: RADIATION

Chemoradiation with capecitabine (825 mg/m2 orally twice daily, Monday through Friday, on days of radiation only) and radiation (50.4 Gy in 28 fractions over 28 days)

Interventions

Pembrolizumab

Pembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment

Intervention Type: DRUG

Neoadjuvant Chemoradiation

Chemoradiation with capecitabine (825 mg/m2 orally twice daily, Monday through Friday, on days of radiation only) and radiation (50.4 Gy in 28 fractions over 28 days)

Intervention Type: RADIATION

Other Intervention Names

MK-3475; Keytruda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig L Slingluff, Jr

OTHER

Sponsor Role: lead

Responsible Party

Craig L Slingluff, Jr

Director of the UVA Human Immune Therapy Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Osama Rahma, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

Mayo Clinic Cancer Center

Phoenix, Arizona, United States

Site Status: RECRUITING

Hartford HealthCare

Hartford, Connecticut, United States

Site Status: RECRUITING

University of Miami

Miami, Florida, United States

Site Status: COMPLETED

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

MD Anderson

Houston, Texas, United States

Site Status: RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Justin Alicea

Role: CONTACT

xzy7tw@virginia.edu

434-243-5350

Katie Rea

Role: CONTACT

kaw3j@virginia.edu

434-924-8574

Facility Contacts

Justin Weber

Role: primary

855-776-0015

Role: backup

weber.justin@mayo.edu

Leah Persky

Role: primary

leah.persky@hhchealth.org

Katherine Metayer

Role: primary

KatherineA_Metayer@DFCI.HARVARD.EDU

617-632-6316

Osama Rahma, MD

Role: backup

OsamaE_Rahma@DFCI.HARVARD.EDU

Edsel Esquivel

Role: primary

EFEsquivel@mdanderson.org

Adela Mahmutovic

Role: primary

am6bd@hscmail.mcc.virginia.edu

Other Identifiers

17801

Identifier Type: -

Identifier Source: org_study_id