Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT04447092
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 iv D1, 8, 15 (every 4 weeks)
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel 125 mg/m2 iv D1, 8, 15 (every 4 weeks)
  • Pembrolizumab — DRUG
    Pembrolizumab ( 200 ) mg iv D1 (every 3 weeks)
  • Oxaliplatin — DRUG
    Oxaliplatin 65 mg/m2 iv over 2 hours D1 (every 2 weeks)
  • Leucovorin — DRUG
    Leucovorin 400 mg/m2 iv D1 (every 2 weeks)
  • Irinotecan — DRUG
    Irinotecan 140 mg/m2 iv over 1.5 hours D1 (every 2 weeks)
  • 5FU — DRUG
    5-FU 2400 mg/m2 iv over 46 hours D1 (every 2 weeks)

Study Details

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

Key Dates

Start date
Jul 1, 2020
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
77 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine/Nab-paclitaxel
    Gemcitabine/Nab-paclitaxel + pembrolizumab
  • Experimental: FOLFIRINOX
    FOLFIRINOX + pembrolizumab

Primary Outcome Measure

Objective Response Rate [ Time Frame: 8 weeks ]

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