Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

NCT04447092 | Active Not Recruiting Phase 2

• 1 other identifier: H-2003-235-1115
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, phase 2 study of Pembrolizumab in combination with chemotherapy in chemotherapy-naïve advanced pancreatic cancer

Conditions

Pancreatic Cancer; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The percentage of patients whose optimal response achieves CR or PR between the initial response assessment and the time between treatment termination or intermediate dropout due to any cause

  8 weeks

Secondary Outcomes (5)

• Progression-free survival

  8 weeks

• Duration of response

  8 weeks

• Disease control rate

  8 weeks

• Overall survival

  8 weeks

• Immune-related response

  8 weeks

Study Arms (2)

Gemcitabine/Nab-paclitaxel

EXPERIMENTAL

Gemcitabine/Nab-paclitaxel + pembrolizumab

Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Pembrolizumab

FOLFIRINOX

EXPERIMENTAL

FOLFIRINOX + pembrolizumab

Drug: Pembrolizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5FU

Interventions

Gemcitabine DRUG

Gemcitabine 1000 mg/m2 iv D1, 8, 15 (every 4 weeks)

Gemcitabine/Nab-paclitaxel

Nab-paclitaxel DRUG

Nab-paclitaxel 125 mg/m2 iv D1, 8, 15 (every 4 weeks)

Gemcitabine/Nab-paclitaxel

Pembrolizumab DRUG

Pembrolizumab ( 200 ) mg iv D1 (every 3 weeks)

FOLFIRINOX; Gemcitabine/Nab-paclitaxel

Oxaliplatin DRUG

Oxaliplatin 65 mg/m2 iv over 2 hours D1 (every 2 weeks)

FOLFIRINOX

Leucovorin DRUG

Leucovorin 400 mg/m2 iv D1 (every 2 weeks)

FOLFIRINOX

Irinotecan DRUG

Irinotecan 140 mg/m2 iv over 1.5 hours D1 (every 2 weeks)

FOLFIRINOX

5FU DRUG

5-FU 2400 mg/m2 iv over 46 hours D1 (every 2 weeks)

FOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female participants who are at least 18 years of age on the day of signing informed consent
• Histologically confirmed diagnosis of unresectable, recurrent, or metastatic pancreatic cancer
• Not pregnant, not breasfeeding, and agree to use proper contraception,
• Chemotherapy-naïve for advanced pancreatic cancer (previous adjuvant chemotherapy is allowed)
• Have measurable disease based on RECIST 1.1.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• 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

You may not qualify if:

• A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation
• 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).
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks
• Has received prior radiotherapy within 2 weeks of start of study treatment.
• Has received a live vaccine within 30 days prior to the first dose of study drug.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device
• 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.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has known active CNS metastases and/or carcinomatous meningitis.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has active autoimmune disease that has required systemic treatment in the past 2 years
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a known history of Human Immunodeficiency Virus (HIV).
• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; pembrolizumab; Oxaliplatin; Leucovorin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones

Study Officials

• Do-Youn Oh, M.D., PhD.

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)