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AzTrials

Pancreatic Cancer Non-resectablePhase 3LAPISNCT03941093

Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer

A Phase 3 study testing Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX in people with Pancreatic Cancer Non-resectable, run by Kyntra Bio at 90 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer Non-resectable
What is being tested?
Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
284 participants
Where
90 sitesin 12 countries
Study dates
10 May 2019to 11 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Understand and sign informed consent; be willing to comply with study procedures, including surgery
  • Age ≥ 18 years
  • Be a male, or non-pregnant and non-lactating female
  • Negative serum B-hCG pregnancy test at screening for women of childbearing potential
  • Male participants with partners of childbearing potential and female participants of childbearing potential are required to use highly effective contraception methods during the conduct of the study and for 6 months after the last dose of study drug
  • Histologically or cytologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
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  • Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging
  • Measurable disease as defined by RECIST 1.1 criteria as determined by central imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN), alkaline phosphatase <2.5 x ULN, and bilirubin ≤1.5 x ULN or in participants with biliary stenting ≤2.0 x ULN
  • Adequate bone marrow function: platelets >100,000 cells/mm3, hemoglobin >9.0 g/dl and absolute neutrophil count (ANC) >1,500 cells/mm3
  • Adequate renal function: creatinine < 1.5 x ULN, creatinine clearance ≥ 30 mL/min
  • Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)

Who cannot join

  • Prior chemotherapy or radiation for pancreatic cancer
  • Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
  • Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.
  • History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
  • History of allergy or hypersensitivity to any of the chemotherapy agents being prescribed or their excipients
  • Any medical or surgical condition that may place the participant at increased risk while on study
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  • Any condition potentially decreasing compliance to study procedures
  • Exposure to another investigational drug within 28 days of first dosing visit, or 5 half-lives of the investigational drug (whichever is longer)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Documented history of drug or alcohol abuse within 6 months of signing informed consent
  • Any medical condition that, in the opinion of the investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation
  • Participants with a history of interstitial pulmonary disease, hepatitis C virus (HCV), hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection
  • Participants who have been administered a live vaccine within 4 weeks prior to the first administration of therapy
  • Participants who cannot stop chronic medications that inhibit or induce cytochrome P (CYP) 2C8 or CYP3A4
  • Participants with poorly controlled comorbid conditions, including; congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) or limited function

Trial locations and contacts

90 sites in 12 countries.

90 sites in 12 countries

United States32 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87131

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Ohio State University

    Columbus, Ohio, 43210

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center

    Elmhurst, Illinois, 60126

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 48202

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

  • UCLA

    Los Angeles, California, 90095

  • Norton Cancer Institute, Audubon Hospital Campus

    Louisville, Kentucky, 40217

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • NYU Langone Health

    New York, New York, 11735

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital and Medical Cancer Center

    Phoenix, Arizona, 85004

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Maine Health Cancer Care

    South Portland, Maine, 04106

  • Stony Brook University

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508

  • Renovatio Clinic

    The Woodlands, Texas, 77380

  • Reading Hospital McGlinn Cancer Institute

    West Reading, Pennsylvania, 19611

  • University of Kansas Hospital

    Westwood, Kansas, 66205

  • University of Massachusetts

    Worcester, Massachusetts, 01655

Other trials in United States

France10 sites

  • CHRU Jean Minjoz

    Besançon, 25030

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Hopital BEAUJON

    Clichy, 92118

  • Centre Georges-François Leclerc

    Dijon, 21079

  • CHU Grenoble Alpes

    La Tronche, 38700

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Groupe Hospitalier Pitié Salpêtrière

    Paris, 750013

  • Haut-Lévêque

    Pessac, 33604

  • Institut de Cancérologie de l'Ouest Pays de Loire

    Saint-Herblain, 44805

Other trials in France

Spain9 sites

  • Hospital Universitaro Vall D'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Institut Catalá d'Oncologia (ICO Girona). Hospital Dr. Josep Trueta

    Girona, 17007

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Alvaro Cunqueiro Hospital

    Vigo, Pontevedra, 36312

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

China8 sites

  • West China Hospital of Sichuan University

    Chengdu

  • Peking Union Medical College Hospital

    Dongcheng, Beijing Municipality, 100010

  • Huashan Hospital affiliated with Fudan University

    Jing’an, Shanghai Municipality, 200040

  • Jiangsu Province Hospital

    Nanjing

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School Of Medicine

    Shanghai

  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, Shaanxi

Other trials in China

Italy7 sites

  • Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck

    Milan, 20162

  • AOU Federico II

    Naples, 80131

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • CRC di Verona

    Verona, 37134

Other trials in Italy

South Korea7 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Seoul National University Budang Hospital

    Seongnam-si, Geyonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Canada4 sites

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre/University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany4 sites

  • Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie

    Berlin, 10117

  • Technische Universität Dresden, Medizinische Klinik und Poliklinik I

    Dresden, 01307

  • Klinikum der Universität München, Medizinische Klinik und Poliklinik III

    München, 81377

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

Other trials in Germany

Israel4 sites

  • Shamir Medical center Asaf Harofeh

    Be’er Ya‘aqov, 7030000

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 9112001

  • Meir Medical center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

Other trials in Israel

Austria2 sites

  • Medizinische Universität Wien

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

United Kingdom2 sites

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Imperial College Healthcare NHS Trust

    London, W2 1NY

Other trials in United Kingdom

Belgium1 site

  • CUB Hôpital Erasme

    Brussels, 1070

Other trials in Belgium

About this study

Official title: A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer

This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.

Read the detailed description

Participants will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with either G/NP or FOLFIRINOX, placebo with G/NP or FOLFIRINOX.

Each participant may receive up to 6 cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection to determine surgical outcome and for biomarker analysis. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.

All participants randomized will have a safety follow-up visit approximately 28 days after the last dose of study treatment and a final safety follow-up phone call at approximately 60 days after the last dose.

Participants who complete study treatment will be evaluated for surgical exploration for possible R0 or R1 resection. Surgery will occur at least 4 weeks after the last dose (allowing for a wash-out period from treatment) and only after receipt of the recommendation from the central review board with regards to surgical eligibility. Surgery will occur no longer than 8 weeks after the last dose. Participants who undergo surgery will be evaluated for surgical complications for at least an additional 90 days following discharge from surgery.

Participants who are ineligible for surgical exploration (i.e. participants who did not complete study treatment or do not meet any of the protocol defined criteria or had a contraindication to surgery) will continue in the Follow-up period and receive treatment as per standard of care (SOC) for each institution.

All participants will be followed for disease progression (if not previously detected) or recurrence following resection (local progression or metastatic disease). Participants will also be followed for any additional anti-cancer therapy received for their pancreatic cancer. All participants will be followed for survival (until death) or until the last participant to complete treatment reaches 18 months post-treatment.

Being tested
Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX, Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX
Keywords
locally advanced pancreatic cancer, unresectable pancreatic cancer

What participants receive

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

  • Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOXDrug

    Also called FG-3019, Gemzar, Abraxane, Eloxitan

    Drug: Pamrevlumab is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion.

    Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.

    Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.

    Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil.

  • Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOXDrug

    Also called Gemzar, Abraxane, Eloxitan, Leucovorin

    Drug: Placebo is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion.

    Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.

    Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.

    Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil.

Study groups in NCT03941093
Study groupRoleWhat they receive
Arm AExperimentalPamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX
Receives: Drug: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX
Arm BPlacebo comparatorPlacebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX
Receives: Drug: Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX

What is being measured

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

  1. Overall Survival

    Overall survival was defined as the time from date of randomization to date of death due to any cause. Overall survival was calculated using the Kaplan-Meier method.

    Measured: Up to approximately 5 years

Secondary outcomes (3)

  1. Event-free Survival (EFS)

    The EFS endpoint was a composite time-to-event endpoint. The event being analyzed ('treatment failure') was defined as the earliest occurrence of: a) failure to achieve disease-free status locally after completion of neoadjuvant treatment and/or after surgery (that is, resection failure or progression that precludes surgery); b) local or distant recurrence, or c) death. The EFS was calculated using the Kaplan-Meier method.

    Measured: Up to approximately 5 years

  2. Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    The PFS was defined as time from date of randomization until disease progression or death due to any cause, whichever occurred first. PFS was calculated using the Kaplan-Meier method. Progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions and the appearance of one or more new lesions was also considered progression.

    Measured: Up to approximately 5 years

  3. Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1

    Best overall objective response was defined as a complete response (CR) or partial response (PR). CR was defined as disappearance of all target or non-target lesions and normalization of tumor marker level (for non-target lesions), any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 5 years

Timeline

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

  1. First posted7 May 2019
  2. Study start10 May 2019
  3. Primary completion11 Jun 2024
  4. Study completion11 Jun 2024

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with G/NP or FOLFIRINOX or placebo with G/NP or FOLFIRINOX.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941093
Sponsor's protocol ID
FGCL-3019-087
Acronym
LAPIS
Status last verified
Sep 2024
First submitted
2 May 2019
Last updated
5 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX in people with Pancreatic Cancer Non-resectable, run by Kyntra Bio at 90 sites in 12 countries.

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 13 inclusion and 15 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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, France, Spain, China, Italy and 7 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: Up to approximately 5 years). 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 NCT03941093.

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 5 Nov 2024.

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