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

NCT ID: NCT02923921

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 567 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-03-05

Brief 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.

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegilodecakin + FOLFOX

Pegilodecakin 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.

Group Type: EXPERIMENTAL

Pegilodecakin

Intervention Type: BIOLOGICAL

Pegilodecakin plus FOLFOX

FOLFOX

Intervention Type: DRUG

FOLFOX Alone

FOLFOX

FOLFOX (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.

Group Type: ACTIVE_COMPARATOR

FOLFOX

Intervention Type: DRUG

FOLFOX Alone

Interventions

Pegilodecakin

Pegilodecakin plus FOLFOX

Intervention Type: BIOLOGICAL

FOLFOX

FOLFOX Alone

Intervention Type: DRUG

Other Intervention Names

LY3500518; AM0010; oxaliplatin; 5-FU; leucovorin

Eligibility Criteria

Inclusion Criteria

1. The presence of metastatic pancreatic adenocarcinoma

2. Measurable disease per RECIST v.1.1

3. Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan

4. Eastern Cooperative Oncology Group Performance Status of 0 - 1

5. Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline

6. Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.

7. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study

8. No peripheral neuropathy

9. No known history of dihydropyrimidine dehydrogenase deficiency

Exclusion Criteria

1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma

2. 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.

3. Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen

4. Participants who were intolerant of a gemcitabine containing regimen.

5. History of positivity for human immunodeficiency virus

6. Chronic active or active viral hepatitis A, B, or C infection

7. Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)

8. Pregnant or lactating women

9. Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders

10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks

11. 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

12. Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARMO BioSciences

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Cancer Treatment Centers of America

Goodyear, Arizona, United States

University of Arizona Cancer Center

Phoenix, Arizona, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

St. Joseph Heritage Healthcare

Fullerton, California, United States

USC Norris Cancer Hospital

Los Angeles, California, United States

TRIO - Translational Research in Oncology-US, Inc.

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Cancer Care Associates Medical Group

Redondo Beach, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Lynn Cancer Institute Ctr for Hem-Onc

Boca Raton, Florida, United States

Memorial Regional Hospital/Joe Dimaggio Childrens Hospital

Hollywood, Florida, United States

Baptist Cancer Institute

Jacksonville, Florida, United States

Watson Clinic

Lakeland, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

UF Health Cancer Center- Orlando Health

Orlando, Florida, United States

Northeast Georgia Cancer Care, LLC

Athens, Georgia, United States

Southeastern Regional Medical Center

Newnan, Georgia, United States

Saint Alphonsus Regional Medical Center

Caldwell, Idaho, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Fort Wayne Oncology & Hematology

Fort Wayne, Indiana, United States

St. Elizabeth Medical Center

Edgewood, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States

New England Cancer Specialists - Scarborough

Scarborough, Maine, United States

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

Boston, Massachusetts, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

St Louis Cancer Care

Bridgeton, Missouri, United States

Summit Medical Group

Summit, New Jersey, United States

North Shore Hematology Oncology Associates

East Setauket, New York, United States

Winthrop University Hospital

Mineola, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Novant Health, Oncology Research Institute

Winston-Salem, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

Texas Oncology-Austin Midtown

Austin, Texas, United States

Texas Oncology-Plano East

Plano, Texas, United States

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, United States

US Oncology

The Woodlands, Texas, United States

Hope Cancer Center of East Texas

Tyler, Texas, United States

Texas Oncology - Tyler

Tyler, Texas, United States

Texas Oncology-Wichital Falls Texoma Cancer Center

Wichita Falls, Texas, United States

University of Utah School of Medicine

Salt Lake City, Utah, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Medical Oncology Associates, PS

Spokane, Washington, United States

MultiCare Regional Cancer Center - Auburn

Tacoma, Washington, United States

Aurora West Allis Medical Center

Green Bay, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

St Vincent's Hospital

Sydney, New South Wales, Australia

Warringal Private Hospital

Heidelberg, Victoria, Australia

Cabrini Hospital Malvern

Malvern, Victoria, Australia

St John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Universitätsklinikum Graz

Graz, Styria, Austria

KH der Barmherzigen Schwestern Linz BetriebsGesmbH

Linz, Upper Austria, Austria

Universitätsklinikum Salzburg

Salzburg, , Austria

Imeldaziekenhuis

Bonheiden, , Belgium

Hospital Universitaire Erasme Brussel

Brussels, , Belgium

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Grand Hopital de Charleroi-Site Notre-Dame

Charleroi, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

AZ Groeninge

Kortrijk, , Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Clinique St Elisabeth Namur

Namur, , Belgium

CHU Dinant Godinne - UCL Namur

Yvoir, , Belgium

Toronto Sunnybrook Regional Cancer Center

Toronto, Ontario, Canada

McGill University

Montreal, Quebec, Canada

CHU de Besancon Hopital Jean Minjoz

Besançon, , France

Hopital de la Pitie Salpetriere

Paris, , France

CHU la Miletrie

Poitiers, , France

Hôpital Nord Franche-Comté

Trévenans, , France

Städtisches Klinikum München

München, Bavaria, Germany

Kliniken Essen-Mitte Ev. Huyssens-Stiftung

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Charité Universitätsmedizin Berlin

Berlin, , Germany

St Josef-Hospital Bochum

Bochum, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

Meldola, Forli, Italy

Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

Candiolo, Torino, Italy

Ospedale le Torrette

Ancona, , Italy

Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

Genova, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

Ospedale Niguarda Ca Granda

Milan, , Italy

AOU dell'Università degli Studi della Campania Luigi Vanvitelli

Naples, , Italy

Istituto Oncologico Veneto

Padua, , Italy

Policlinico San Matteo

Pavia, , Italy

Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

Reggio Emilia, , Italy

Universita Campus Biomedico

Roma, , Italy

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg

Poznan, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Wojewodzki Szpital Zespolony

Torun, , Poland

Dong-A University Medical Center

Busan, Busan Gwang'yeogsi, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Severance Hospital Yonsei University Health System

Seoul, Korea, South Korea

Samsung Medical Center

Seoul, Korea, South Korea

Seoul St. Mary's Hospital

Seoul, Korea, South Korea

Asan Medical Center

Seoul, , South Korea

Hospital Duran I Reynals

Hospitaled de Llobre, Barcelona, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, La Coruna, Spain

Hospital General Universitario Alicante

Alicante, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitario Germans Trias i Pujol

Barcelona, , Spain

Hospital General Yague

Burgos, , Spain

C.H. Regional Reina Sofia

Córdoba, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Madrid Norte Sanchinarro

Madrid, , Spain

Regional University Hospital in Malaga

Málaga, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Tri-Service General Hospital

Neihu Taipei, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

Hammersmith Hospital

Acton, London, United Kingdom

Velindre Hospital

Cardiff, South Glamorgan, United Kingdom

University College London Hospital Foundation Trust

London, Surrey, United Kingdom

Guys/St. Thomas Hospital

London, Surrey, United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; France; Germany; Italy; Poland; South Korea; Spain; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33555926 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J1L-AM-JZGB

Identifier Type: OTHER

Identifier Source: secondary_id

AM0010-301

Identifier Type: OTHER

Identifier Source: secondary_id

2016-003858-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17158

Identifier Type: -

Identifier Source: org_study_id