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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pegilodecakin
FOLFOX
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson Cancer Center
  • Cancer Treatment Centers of America
  • University of Arizona Cancer Center
  • Comprehensive Blood and Cancer Center
  • St. Joseph Heritage Healthcare
  • USC Norris Cancer Hospital
  • TRIO - Translational Research in Oncology-US, Inc.
  • UCLA Medical Center
  • Cancer Care Associates Medical Group
  • Central Coast Medical Oncology Corporation
  • Rocky Mountain Cancer Center
  • Georgetown University Medical Center
  • Lynn Cancer Institute Ctr for Hem-Onc
  • Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
  • Baptist Cancer Institute
  • Watson Clinic
  • Florida Hospital Cancer Institute
  • UF Health Cancer Center- Orlando Health
  • Northeast Georgia Cancer Care, LLC
  • Southeastern Regional Medical Center
  • Saint Alphonsus Regional Medical Center
  • Decatur Memorial Hospital
  • Fort Wayne Oncology & Hematology
  • St. Elizabeth Medical Center
  • Norton Cancer Institute
  • Hematology Oncology Clinic
  • New England Cancer Specialists - Scarborough
  • Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB
  • University of Massachusetts Medical Center
  • Virginia Piper Cancer Institute
  • St Louis Cancer Care
  • Summit Medical Group
  • North Shore Hematology Oncology Associates
  • Winthrop University Hospital
  • Duke University Medical Center
  • Novant Health, Oncology Research Institute
  • Gabrail Cancer Center
  • University of Oklahoma Health Sciences Center
  • Oregon Health and Science University
  • Gettysburg Cancer Center
  • Eastern Regional Medical Center
  • UPMC Hillman Cancer Center
  • Sarah Cannon Research Institute SCRI
  • Tennessee Oncology PLLC
  • Texas Oncology-Austin Midtown
  • Texas Oncology-Plano East
  • Texas Oncology - San Antonio Medical Center
  • US Oncology
  • Hope Cancer Center of East Texas
  • Texas Oncology - Tyler
  • Texas Oncology-Wichital Falls Texoma Cancer Center
  • University of Utah School of Medicine
  • Virginia Cancer Institute
  • Medical Oncology Associates, PS
  • MultiCare Regional Cancer Center - Auburn
  • Aurora West Allis Medical Center
  • Medical College of Wisconsin
  • St Vincent's Hospital
  • Warringal Private Hospital
  • Cabrini Hospital Malvern
  • St John of God Murdoch Hospital
  • KH der Barmherzigen Schwestern Linz BetriebsGesmbH
  • Universitätsklinikum Graz
  • Universitätsklinikum Salzburg
  • Imeldaziekenhuis
  • Hospital Universitaire Erasme Brussel
  • Universitair Ziekenhuis Brussel
  • Grand Hopital de Charleroi-Site Notre-Dame
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • AZ Groeninge
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Clinique St Elisabeth Namur
  • CHU Dinant Godinne - UCL Namur
  • Toronto Sunnybrook Regional Cancer Center
  • McGill University
  • CHU de Besancon Hopital Jean Minjoz
  • Hopital de la Pitie Salpetriere
  • CHU la Miletrie
  • Hôpital Nord Franche-Comté
  • Städtisches Klinikum München
  • Kliniken Essen-Mitte Ev. Huyssens-Stiftung
  • Universitätsklinikum Carl Gustav Carus
  • Charité Universitätsmedizin Berlin
  • St Josef-Hospital Bochum
  • Universitätsklinikum Freiburg
  • Asklepios Klinik Altona
  • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
  • Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
  • Ospedale le Torrette
  • Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
  • IRCCS Ospedale San Raffaele
  • Ospedale Niguarda Ca Granda
  • AOU dell'Università degli Studi della Campania Luigi Vanvitelli
  • Istituto Oncologico Veneto
  • Policlinico San Matteo
  • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
  • Universita Campus Biomedico
  • Dong-A University Medical Center
  • Chonnam National University Hwasun Hospital
  • Severance Hospital Yonsei University Health System
  • Samsung Medical Center
  • Seoul St. Mary's Hospital
  • Asan Medical Center
  • Uniwersyteckie Centrum Kliniczne
  • Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg
  • Centrum Medyczne Medyk
  • Wojewodzki Szpital Zespolony
  • Hospital Duran I Reynals
  • Hospital Clinico Universitario de Santiago
  • Hospital General Universitario Alicante
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Germans Trias i Pujol
  • Hospital General Yague
  • C.H. Regional Reina Sofia
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Madrid Norte Sanchinarro
  • Regional University Hospital in Malaga
  • Hospital Universitario Virgen del Rocio
  • Tri-Service General Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • Addenbrookes Hospital
  • Hammersmith Hospital
  • Velindre Hospital
  • University College London Hospital Foundation Trust
  • Guys/St. Thomas Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pegilodecakin + FOLFOX

FOLFOX

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 30, 2016
Last Updated
September 24, 2020
Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT02923921
Brief Title
Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Acronym
Sequoia
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

2. Study Status

Record Verification Date
April 15, 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
567 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pegilodecakin + FOLFOX
Arm Type
Experimental
Arm Description
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.
Arm Title
FOLFOX
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pegilodecakin
Other Intervention Name(s)
LY3500518, AM0010
Intervention Description
Pegilodecakin plus FOLFOX
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Other Intervention Name(s)
oxaliplatin, 5-FU, leucovorin
Intervention Description
FOLFOX Alone
Primary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
Randomization to date of death from any cause (Up To 30 Months)
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Title
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
Description
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.
Time Frame
Randomization to PD (Up To 30 Months)
Title
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
Description
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.
Time Frame
Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)
Title
Duration of Response (DOR)
Description
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.
Time Frame
Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Title
Percentage of Participants Alive at 1 Year (12-Month Survival Rate)
Description
The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.
Time Frame
From randomization to until the date of first documented date of death from any cause within 12 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
33555926
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.
Results Reference
derived

Learn more about this trial

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

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