Overview

Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, phase 2 study of Pembrolizumab in combination with chemotherapy in chemotherapy-naïve advanced pancreatic cancer
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Gemcitabine
Irinotecan
Leucovorin
Oxaliplatin
Paclitaxel
Pembrolizumab
Criteria
Inclusion Criteria:

1. Male/female participants who are at least 18 years of age on the day of signing
informed consent

2. Histologically confirmed diagnosis of unresectable, recurrent, or metastatic
pancreatic cancer

3. Not pregnant, not breasfeeding, and agree to use proper contraception,

4. Chemotherapy-naïve for advanced pancreatic cancer (previous adjuvant chemotherapy is
allowed)

5. Have measurable disease based on RECIST 1.1.

6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

7. Have adequate organ function

- Haemoglobin ≥ 9.0 g/dL

- Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)

- Platelet count ≥ 100 x 109/L (>75,000 per mm3)

- Serum creatinine CL>30 mL/min by the Cockcroft-Gault formula or serum creatinine
≤1.5 × ULN

- Serum bilirubin ≤ 1.5 x ULN

- AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN unless liver metastases are present, in which
case it must be ≤ 5x ULN

- International normalized ratio (INR) or Prothrombin time (PT), activated partial
thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving
anticoagulant therapy

Exclusion Criteria:

1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation

2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4,
OX 40, CD137).

3. Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks

4. Has received prior radiotherapy within 2 weeks of start of study treatment.

5. Has received a live vaccine within 30 days prior to the first dose of study drug.

6. Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device

7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study drug.

8. Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years.

9. Has known active CNS metastases and/or carcinomatous meningitis.

10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

11. Has active autoimmune disease that has required systemic treatment in the past 2 years

12. Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.

13. Has an active infection requiring systemic therapy.

14. Has a known history of Human Immunodeficiency Virus (HIV).

15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is
detected) infection.

16. Has a known history of active TB (Bacillus Tuberculosis).

17. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the subject's
participation for the full duration of the study, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator.

18. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

19. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of trial treatment.