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Trial record 1 of 1 for:    am0010 | Phase 3
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Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (Sequoia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923921
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: Pegilodecakin Drug: FOLFOX Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 9, 2019
Actual Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: Pegilodecakin
Pegilodecakin plus FOLFOX
Other Names:
  • LY3500518
  • AM0010

Drug: FOLFOX
FOLFOX Alone
Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin

Active Comparator: 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.
Drug: FOLFOX
FOLFOX Alone
Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Randomization to date of death from any cause (Up To 30 Months) ]
    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.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months) ]
    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.

  2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator [ Time Frame: Randomization to PD (Up To 30 Months) ]
    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.

  3. Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) [ Time Frame: Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months) ]
    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.

  4. Duration of Response (DOR) [ Time Frame: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months) ]
    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.

  5. Percentage of Participants Alive at 1 Year (12-Month Survival Rate) [ Time Frame: From randomization to until the date of first documented date of death from any cause within 12 months ]
    The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923921


Locations
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United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Cancer Treatment Centers of America
Goodyear, Arizona, United States, 85338
University of Arizona Cancer Center
Phoenix, Arizona, United States, 85004
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92935
USC Norris Cancer Hospital
Los Angeles, California, United States, 90033
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, United States, 90095
UCLA Medical Center
Los Angeles, California, United States, 90095
Cancer Care Associates Medical Group
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Lynn Cancer Institute Ctr for Hem-Onc
Boca Raton, Florida, United States, 33486
Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
Hollywood, Florida, United States, 33021
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Watson Clinic
Lakeland, Florida, United States, 33805
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
UF Health Cancer Center- Orlando Health
Orlando, Florida, United States, 32806
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
United States, Idaho
Saint Alphonsus Regional Medical Center
Caldwell, Idaho, United States, 83605
United States, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
United States, Indiana
Fort Wayne Oncology & Hematology
Fort Wayne, Indiana, United States, 46815
United States, Kentucky
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States, 70808
United States, Maine
New England Cancer Specialists - Scarborough
Scarborough, Maine, United States, 04074
United States, Massachusetts
Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB
Boston, Massachusetts, United States, 02215
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St Louis Cancer Care
Bridgeton, Missouri, United States, 63044
United States, New Jersey
Summit Medical Group
Summit, New Jersey, United States, 07902
United States, New York
North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Novant Health, Oncology Research Institute
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States, 19124
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, Tennessee
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology-Plano East
Plano, Texas, United States, 75075
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States, 78240
US Oncology
The Woodlands, Texas, United States, 77380
Hope Cancer Center of East Texas
Tyler, Texas, United States, 75701
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Texas Oncology-Wichital Falls Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Medical Oncology Associates, PS
Spokane, Washington, United States, 99208
MultiCare Regional Cancer Center - Auburn
Tacoma, Washington, United States, 98002
United States, Wisconsin
Aurora West Allis Medical Center
Green Bay, Wisconsin, United States, 54308
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Australia, Victoria
Warringal Private Hospital
Heidelberg, Victoria, Australia, 3084
Cabrini Hospital Malvern
Malvern, Victoria, Australia, 3144
Australia, Western Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Austria
KH der Barmherzigen Schwestern Linz BetriebsGesmbH
Linz, Oberösterreich, Austria, 4010
Universitätsklinikum Graz
Graz, Steiermark, Austria, 8036
Universitätsklinikum Salzburg
Salzburg, Austria, 5020
Belgium
Imeldaziekenhuis
Bonheiden, Belgium, 2820
Hospital Universitaire Erasme Brussel
Brussel, Belgium, 1070
Universitair Ziekenhuis Brussel
Brussel, Belgium, 1090
Grand Hopital de Charleroi-Site Notre-Dame
Charleroi, Belgium, 6000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Clinique St Elisabeth Namur
Namur, Belgium, 5000
CHU Dinant Godinne - UCL Namur
Yvoir, Belgium, 5530
Canada, Ontario
Toronto Sunnybrook Regional Cancer Center
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H3A 1A1
France
CHU de Besancon Hopital Jean Minjoz
Besancon Cedex, France, 25030
Hopital de la Pitie Salpetriere
Paris CEDEX 13, France, 75651
CHU la Miletrie
Poitiers, France, 86021
Hôpital Nord Franche-Comté
Trevenans, France, 90400
Germany
Städtisches Klinikum München
München, Bayern, Germany, 81737
Kliniken Essen-Mitte Ev. Huyssens-Stiftung
Essen, Nordrhein-Westfalen, Germany, 45136
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, Germany, 01307
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
St Josef-Hospital Bochum
Bochum, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Asklepios Klinik Altona
Hamburg, Germany, 22763
Italy
Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
Meldola, Forli, Italy, 47014
Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
Candiolo, Torino, Italy
Ospedale le Torrette
Ancona, Italy, 60100
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
Genova, Italy, 16132
IRCCS Ospedale San Raffaele
Milano, Italy, 20132
Ospedale Niguarda Ca Granda
Milano, Italy, 20162
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Istituto Oncologico Veneto
Padova, Italy, 35128
Policlinico San Matteo
Pavia, Italy, 27100
Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, Italy, 42123
Universita Campus Biomedico
Roma, Italy, 00155
Korea, Republic of
Dong-A University Medical Center
Busan, Busan Gwang'yeogsi, Korea, Republic of, 49201
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonnam, Korea, Republic of, 519-809
Severance Hospital Yonsei University Health System
Seoul, Korea, Korea, Republic of, 03722
Samsung Medical Center
Seoul, Korea, Korea, Republic of, 06351
Seoul St. Mary's Hospital
Seoul, Korea, Korea, Republic of, 06591
Asan Medical Center
Seoul, Korea, Republic of, 05505
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg
Poznan, Poland, 60-569
Centrum Medyczne Medyk
Rzeszow, Poland, 35-025
Wojewodzki Szpital Zespolony
Torun, Poland, 87-100
Spain
Hospital Duran I Reynals
Hospitaled DE Llobre, Barcelona, Spain, 08907
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruna, Spain, 15706
Hospital General Universitario Alicante
Alicante, Spain, 03010
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario Germans Trias i Pujol
Barcelona, Spain
Hospital General Yague
Burgos, Spain, 9005
C.H. Regional Reina Sofia
Córdoba, Spain, 14001
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Regional University Hospital in Malaga
Malaga, Spain, 29011
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Taiwan
Tri-Service General Hospital
Neihu Taipei, Taiwan, 11490
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
United Kingdom
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Hammersmith Hospital
Acton, London, United Kingdom, W12 0HS
Velindre Hospital
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
University College London Hospital Foundation Trust
London, Surrey, United Kingdom, NW1 2BU
Guys/St. Thomas Hospital
London, Surrey, United Kingdom, SE1 9RT
Sponsors and Collaborators
Eli Lilly and Company
ARMO BioSciences
Investigators
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Study Director: 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) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] October 5, 2018
Statistical Analysis Plan  [PDF] April 8, 2019

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02923921    
Other Study ID Numbers: 17158
J1L-AM-JZGB ( Other Identifier: Eli Lilly and Company )
AM0010-301 ( Other Identifier: ARMO BioSciences )
2016-003858-33 ( EudraCT Number )
First Posted: October 5, 2016    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: April 15, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Oxaliplatin
Antineoplastic Agents
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances