Clinical trial NCT02923921: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ARMO BioSciences
First posted: 2016-10-05
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Survival
timeFrame: Randomization to date of death from any cause (Up To 30 Months)
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
measure: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
timeFrame: Randomization to PD (Up To 30 Months)
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
timeFrame: Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)
measure: Duration of Response (DOR)
timeFrame: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
measure: Percentage of Participants Alive at 1 Year (12-Month Survival Rate)
timeFrame: From randomization to until the date of first documented date of death from any cause within 12 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Goodyear
country: United States
facility: Cancer Treatment Centers of America
state: Arizona
city: Phoenix
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Hospital
state: California
city: Los Angeles
country: United States
facility: TRIO - Translational Research in Oncology-US, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Ctr for Hem-Onc
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Orlando
country: United States
facility: UF Health Cancer Center- Orlando Health
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Newnan
country: United States
facility: Southeastern Regional Medical Center
state: Georgia
city: Caldwell
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology
state: Indiana
city: Edgewood
country: United States
facility: St. Elizabeth Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists - Scarborough
state: Maine
city: Boston
country: United States
facility: Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Bridgeton
country: United States
facility: St Louis Cancer Care
state: Missouri
city: Summit
country: United States
facility: Summit Medical Group
state: New Jersey
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health, Oncology Research Institute
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Midtown
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Tyler
country: United States
facility: Hope Cancer Center of East Texas
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology-Wichital Falls Texoma Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Spokane
country: United States
facility: Medical Oncology Associates, PS
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Green Bay
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Warringal Private Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital
state: Western Australia
city: Linz
country: Austria
facility: KH der Barmherzigen Schwestern Linz BetriebsGesmbH
state: Oberösterreich
city: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Steiermark
city: Salzburg
country: Austria
facility: Universitätsklinikum Salzburg
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brussel
country: Belgium
facility: Hospital Universitaire Erasme Brussel
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi-Site Notre-Dame
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Namur
country: Belgium
facility: Clinique St Elisabeth Namur
city: Yvoir
country: Belgium
facility: CHU Dinant Godinne - UCL Namur
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Besancon Cedex
country: France
facility: CHU de Besancon Hopital Jean Minjoz
city: Paris CEDEX 13
country: France
facility: Hopital de la Pitie Salpetriere
city: Poitiers
country: France
facility: CHU la Miletrie
city: Trevenans
country: France
facility: Hôpital Nord Franche-Comté
city: München
country: Germany
facility: Städtisches Klinikum München
state: Bayern
city: Essen
country: Germany
facility: Kliniken Essen-Mitte Ev. Huyssens-Stiftung
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: St Josef-Hospital Bochum
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
state: Forli
city: Candiolo
country: Italy
facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
state: Torino
city: Ancona
country: Italy
facility: Ospedale le Torrette
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Ospedale Niguarda Ca Granda
city: Naples
country: Italy
facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
city: Roma
country: Italy
facility: Universita Campus Biomedico
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
state: Busan Gwang'yeogsi
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Poznan
country: Poland
facility: Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Hospitaled DE Llobre
country: Spain
facility: Hospital Duran I Reynals
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: La Coruna
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Burgos
country: Spain
facility: Hospital General Yague
city: Córdoba
country: Spain
facility: C.H. Regional Reina Sofia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Malaga
country: Spain
facility: Regional University Hospital in Malaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Neihu Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Acton
country: United Kingdom
facility: Hammersmith Hospital
state: London
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
state: South Glamorgan
city: London
country: United Kingdom
facility: University College London Hospital Foundation Trust
state: Surrey
city: London
country: United Kingdom
facility: Guys/St. Thomas Hospital
state: Surrey
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.