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Pancreatic CancerPhase 3SequoiaNCT02923921

Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer

A Phase 3 study testing Pegilodecakin and FOLFOX in people with Pancreatic Cancer, run by Eli Lilly and Company at 130 sites in 13 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

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Pegilodecakin and FOLFOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
567 participants
Where
130 sitesin 13 countries
Study dates
1 Mar 2017to 5 Mar 2020
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

  • The presence of metastatic pancreatic adenocarcinoma
  • Measurable disease per RECIST v.1.1
  • Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
  • Eastern Cooperative Oncology Group Performance Status of 0 - 1
  • Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
  • Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
Show all 9Show fewer
  • Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
  • No peripheral neuropathy
  • No known history of dihydropyrimidine dehydrogenase deficiency

Who cannot join

  • Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
  • Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
  • Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
  • Participants who were intolerant of a gemcitabine containing regimen.
  • History of positivity for human immunodeficiency virus
  • Chronic active or active viral hepatitis A, B, or C infection
Show all 12Show fewer
  • Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
  • Pregnant or lactating women
  • Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
  • Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
  • Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
  • Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1

Trial locations and contacts

130 sites in 13 countries.

130 sites in 13 countries

United States57 sites

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70808

  • Lynn Cancer Institute Ctr for Hem-Onc

    Boca Raton, Florida, 33486

  • Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB

    Boston, Massachusetts, 02215

  • St Louis Cancer Care

    Bridgeton, Missouri, 63044

  • Saint Alphonsus Regional Medical Center

    Caldwell, Idaho, 83605

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • Fort Wayne Oncology & Hematology

    Fort Wayne, Indiana, 46815

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92935

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Cancer Treatment Centers of America

    Goodyear, Arizona, 85338

  • Aurora West Allis Medical Center

    Green Bay, Wisconsin, 54308

  • Memorial Regional Hospital/Joe Dimaggio Childrens Hospital

    Hollywood, Florida, 33021

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Watson Clinic

    Lakeland, Florida, 33805

  • USC Norris Cancer Hospital

    Los Angeles, California, 90033

  • TRIO - Translational Research in Oncology-US, Inc.

    Los Angeles, California, 90095

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73190

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • UF Health Cancer Center- Orlando Health

    Orlando, Florida, 32806

  • Eastern Regional Medical Center

    Philadelphia, Pennsylvania, 19124

  • University of Arizona Cancer Center

    Phoenix, Arizona, 85004

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232-1305

  • Texas Oncology-Plano East

    Plano, Texas, 75075

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Cancer Care Associates Medical Group

    Redondo Beach, California, 90277

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • New England Cancer Specialists - Scarborough

    Scarborough, Maine, 04074

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • Summit Medical Group

    Summit, New Jersey, 07902

  • MultiCare Regional Cancer Center - Auburn

    Tacoma, Washington, 98002

  • US Oncology

    The Woodlands, Texas, 77380

  • Hope Cancer Center of East Texas

    Tyler, Texas, 75701

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Texas Oncology-Wichital Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Novant Health, Oncology Research Institute

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Spain14 sites

  • Hospital General Universitario Alicante

    Alicante, 03010

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Germans Trias i Pujol

    Barcelona

  • Hospital General Yague

    Burgos, 9005

  • C.H. Regional Reina Sofia

    Córdoba, 14001

  • Hospital Duran I Reynals

    Hospitaled de Llobre, Barcelona, 08907

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

  • Regional University Hospital in Malaga

    Málaga, 29011

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Italy11 sites

  • Ospedale le Torrette

    Ancona, 60100

  • Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

    Candiolo, Torino

  • Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

    Genova, 16132

  • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

    Meldola, Forli, 47014

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Ospedale Niguarda Ca Granda

    Milan, 20162

  • AOU dell'Università degli Studi della Campania Luigi Vanvitelli

    Naples

  • Istituto Oncologico Veneto

    Padova, 35128

  • Policlinico San Matteo

    Pavia, 27100

  • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia, 42123

  • Universita Campus Biomedico

    Roma, 00155

Other trials in Italy

Belgium10 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • Hospital Universitaire Erasme Brussel

    Brussels, 1070

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Grand Hopital de Charleroi-Site Notre-Dame

    Charleroi, 6000

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Clinique St Elisabeth Namur

    Namur, 5000

  • CHU Dinant Godinne - UCL Namur

    Yvoir, 5530

Other trials in Belgium

Germany7 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • St Josef-Hospital Bochum

    Bochum

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

  • Kliniken Essen-Mitte Ev. Huyssens-Stiftung

    Essen, North Rhine-Westphalia, 45136

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Städtisches Klinikum München

    München, Bavaria, 81737

Other trials in Germany

South Korea6 sites

  • Dong-A University Medical Center

    Busan, Busan Gwang'yeogsi, 49201

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 519-809

  • Severance Hospital Yonsei University Health System

    Seoul, Korea, 03722

  • Samsung Medical Center

    Seoul, Korea, 06351

  • Seoul St. Mary's Hospital

    Seoul, Korea, 06591

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

United Kingdom5 sites

  • Hammersmith Hospital

    Acton, London, W12 0HS

  • Addenbrookes Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Velindre Hospital

    Cardiff, South Glamorgan, CF14 2TL

  • University College London Hospital Foundation Trust

    London, Surrey, NW1 2BU

  • Guys/St. Thomas Hospital

    London, Surrey, SE1 9RT

Other trials in United Kingdom

Australia4 sites

  • Warringal Private Hospital

    Heidelberg, Victoria, 3084

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • St Vincent's Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

France4 sites

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, 25030

  • Hopital de la Pitie Salpetriere

    Paris, 75651

  • CHU la Miletrie

    Poitiers, 86021

  • Hôpital Nord Franche-Comté

    Trévenans, 90400

Other trials in France

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg

    Poznan, 60-569

  • Centrum Medyczne Medyk

    Rzeszów, 35-025

  • Wojewodzki Szpital Zespolony

    Torun, 87-100

Other trials in Poland

Austria3 sites

  • Universitätsklinikum Graz

    Graz, Styria, 8036

  • KH der Barmherzigen Schwestern Linz BetriebsGesmbH

    Linz, Upper Austria, 4010

  • Universitätsklinikum Salzburg

    Salzburg, 5020

Other trials in Austria

Taiwan3 sites

  • Tri-Service General Hospital

    Neihu Taipei, 11490

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Canada2 sites

  • McGill University

    Montreal, Quebec, H3A 1A1

  • Toronto Sunnybrook Regional Cancer Center

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.

Read the detailed description

This is an open-label, multi-center, randomized, Phase 3 study designed to compare the efficacy and safety of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

Being tested
Pegilodecakin, FOLFOX
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • PegilodecakinBiological

    Also called LY3500518, AM0010

    Pegilodecakin plus FOLFOX

  • FOLFOXDrug

    Also called oxaliplatin, 5-FU, leucovorin

    FOLFOX Alone

Study groups in NCT02923921
Study groupRoleWhat they receive
Pegilodecakin + FOLFOXExperimentalPegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
Receives: Biological: Pegilodecakin; Drug: FOLFOX
FOLFOXActive comparatorFOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
Receives: Drug: FOLFOX

What is being measured

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

  1. Overall Survival

    Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.

    Measured: Randomization to date of death from any cause (Up To 30 Months)

Secondary outcomes (5)

  1. Progression Free Survival

    PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.

    Measured: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

  2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator

    ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.

    Measured: Randomization to PD (Up To 30 Months)

  3. Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)

    Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)

  4. Duration of Response (DOR)

    DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

  5. Percentage of Participants Alive at 1 Year (12-Month Survival Rate)

    The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.

    Measured: From randomization to until the date of first documented date of death from any cause within 12 months

Timeline

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

  1. First posted5 Oct 2016 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion9 Sep 2019
  4. Study completion5 Mar 2020

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
Masking
None (open label)
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923921
Sponsor's protocol ID
17158
Other IDs
J1L-AM-JZGB, AM0010-301, 2016-003858-33, 2016
Acronym
Sequoia
Status last verified
15 Apr 2020
First submitted
30 Sep 2016
Last updated
19 Oct 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.

    PubMed 33555926

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegilodecakin and FOLFOX in people with Pancreatic Cancer, run by Eli Lilly and Company at 130 sites in 13 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 9 inclusion and 12 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Spain, Italy, Belgium, Germany and 8 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. 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 19 Oct 2020). 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: Randomization to date of death from any cause (Up To 30 Months)). 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 NCT02923921, which also lists 1 linked publication.

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 Oct 2020.

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