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Pancreatic CancerPhase 2NCT04447092

Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

A Phase 2 study testing Gemcitabine, Nab-paclitaxel and Pembrolizumab in people with Pancreatic Cancer and Chemotherapy Effect, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Chemotherapy Effect
What is being tested?
Gemcitabine, Nab-paclitaxel and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2020to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • 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.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: Biomarker-oriented Study of Pembrolizumab in Combination With Chemotherapy in Chemotherapy -naïve Advanced Pancreatic Cancer

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

Read the detailed description
  • 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.
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

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

  • Nab-paclitaxelDrug

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

  • PembrolizumabDrug

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

  • OxaliplatinDrug

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

  • LeucovorinDrug

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

  • IrinotecanDrug

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

  • 5FUDrug

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

Study groups in NCT04447092
Study groupRoleWhat they receive
Gemcitabine/Nab-paclitaxelExperimentalGemcitabine/Nab-paclitaxel + pembrolizumab
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Pembrolizumab
FOLFIRINOXExperimentalFOLFIRINOX + pembrolizumab
Receives: Drug: Pembrolizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 weeks

Secondary outcomes (5)

  1. Progression-free survival

    Time from enroll until disease progression or death

    Measured: 8 weeks

  2. Duration of response

    Time from enroll untill disease progression or death in patients whose optimal response achieves CR or PR

    Measured: 8 weeks

  3. Disease control rate

    The percentage of patients who have achieved complete response, partial response and stable disease

    Measured: 8 weeks

  4. Overall survival

    Time from enroll until death from any cause

    Measured: 8 weeks

  5. Immune-related response

    RECIST 1.1, ir response

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start1 Jul 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447092
Sponsor's protocol ID
H-2003-235-1115
Status last verified
Apr 2024
First submitted
23 Jun 2020
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Nab-paclitaxel and Pembrolizumab in people with Pancreatic Cancer and Chemotherapy Effect, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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