Pembrolizumab Plus Chemotherapy In 1st Line Treatment Of Pancreatic Cancer

Study Overview

Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

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

* In unresectable advanced pancreatic cancer, palliative chemotherapy (mainly Gemcitabine/nab-Paclitaxel or FOLFIRINOX) is the mainstay of treatment. Regardless of the choice of first-line therapy, more than half of the patients with advanced/metastatic disease will progress within six months and will not survive more than one year. * Immune cells (IC) are a significant part of the pancreatic tumor-associated stroma and play a fundamental part in maintaining a non-immunogenic and immuno-suppressive environment. * IO (Immuno-Oncology drug) monotherapy is not effective in advanced pancreatic cancer; therefore, we need more active combination regimens including IO/IO or IO/chemotherapy, etc. Furthermore, we need biomarker study to uncover which population is an optimal target for this IO-based treatment strategy. * Based on these rationale, we plan to conduct an open-label, phase 2 study to explore biomarkers and evaluate the safety and efficacy of the pembrolizumab/chemotherapy combination in an advanced pancreatic cancer primary environment.

Pancreatic Cancer
Chemotherapy Effect

DRUG: Gemcitabine
DRUG: Nab-paclitaxel
DRUG: Pembrolizumab
DRUG: Oxaliplatin
DRUG: Leucovorin
DRUG: Irinotecan
DRUG: 5FU

H-2003-235-1115

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-06-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-17
First Submitted that Met QC Criteria 2020-06-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-19
First Posted (ACTUAL) 2020-06-25	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemcitabine/Nab-paclitaxel Gemcitabine/Nab-paclitaxel + pembrolizumab	DRUG: Gemcitabine Gemcitabine 1000 mg/m2 iv D1, 8, 15 (every 4 weeks) DRUG: Nab-paclitaxel Nab-paclitaxel 125 mg/m2 iv D1, 8, 15 (every 4 weeks) DRUG: Pembrolizumab Pembrolizumab ( 200 ) mg iv D1 (every 3 weeks)
EXPERIMENTAL: FOLFIRINOX FOLFIRINOX + pembrolizumab	DRUG: Pembrolizumab Pembrolizumab ( 200 ) mg iv D1 (every 3 weeks) DRUG: Oxaliplatin Oxaliplatin 65 mg/m2 iv over 2 hours D1 (every 2 weeks) DRUG: Leucovorin Leucovorin 400 mg/m2 iv D1 (every 2 weeks) DRUG: Irinotecan Irinotecan 140 mg/m2 iv over 1.5 hours D1 (every 2 weeks) DRUG: 5FU 5-FU 2400 mg/m2 iv over 46 hours D1 (every 2 weeks)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine/Nab-paclitaxel

Gemcitabine/Nab-paclitaxel + pembrolizumab

DRUG: Gemcitabine

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

DRUG: Nab-paclitaxel

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

DRUG: Pembrolizumab

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

EXPERIMENTAL: FOLFIRINOX

FOLFIRINOX + pembrolizumab

DRUG: Pembrolizumab

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

DRUG: Oxaliplatin

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

DRUG: Leucovorin

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

DRUG: Irinotecan

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

DRUG: 5FU

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Progression-free survival	Time from enroll until disease progression or death	8 weeks
Duration of response	Time from enroll untill disease progression or death in patients whose optimal response achieves CR or PR	8 weeks
Disease control rate	The percentage of patients who have achieved complete response, partial response and stable disease	8 weeks
Overall survival	Time from enroll until death from any cause	8 weeks
Immune-related response	RECIST 1.1, ir response	8 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Do-Youn Oh, M.D., PhD., Seoul National University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record