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



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 1, 2017
End Date:March 31, 2020
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

Use our guide to learn which trials are right for you!

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

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

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.

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
We found this trial at
66
sites
San Antonio, Texas 78229
Principal Investigator: Carlos H Becerra
Phone: 210-595-5300
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Charles Lopez
Phone: 503-494-3131
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
220 S Palisade Dr # 204
Santa Maria, California 93454
Principal Investigator: Robert Alan Dichmann
Phone: 3602522500
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
Principal Investigator: Richard Siegel
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Athens, Georgia 30607
Principal Investigator: Petros G Nikolinakos
Phone: 513-761-4100
?
mi
from
Athens, GA
Click here to add this to my saved trials
Austin, Texas 78705
Principal Investigator: Mika Cline-Burkhardt
Phone: 512-421-4100
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bakersfield, California 93309
Principal Investigator: Shekar Chandra Kota
Phone: 3602522500
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Yousuf A Gaffar
Phone: 206-448-4082
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
Principal Investigator: Gerald Miletello
Phone: 225-767-0822
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Blue Island, Illinois 60406
Principal Investigator: Subramanya Rao
Phone: 708-388-2245
?
mi
from
Blue Island, IL
Click here to add this to my saved trials
Boca Raton, Florida 33486
Principal Investigator: Warren S Brenner
Phone: 206-448-4082
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Boston, Massachusetts 02215
Principal Investigator: Andrea Bullock
Phone: 617-632-3029
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeton, Missouri 63044
Principal Investigator: Juan Daniel Cuevas
Phone: 3142913312
?
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Caldwell, Idaho 83605
Principal Investigator: Kerry Pulver
Phone: 208-367-7676
?
mi
from
Caldwell, ID
Click here to add this to my saved trials
4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Y Gabrail
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
?
mi
from
Canton, OH
Click here to add this to my saved trials
Chattanooga, Tennessee 37401
Principal Investigator: Robert Matthew Graham
Phone: 2064484082
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: Mark Johns
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Dallas, Texas 75246
Principal Investigator: Anish Meerasahib
Phone: 214-820-8799
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: JAMES L. WADE
Phone: 217-876-6639
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
?
mi
from
Decatur, IL
Click here to add this to my saved trials
Denver, Colorado 80218
Principal Investigator: Sujatha Nallapareddy
Phone: 303-430-2700
?
mi
from
Denver, CO
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Niharika Mettu
Phone: 919-668-5111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
East Setauket, New York 11733
Principal Investigator: David Chu
Phone: 206-448-4082
?
mi
from
East Setauket, NY
Click here to add this to my saved trials
Edgewood, Kentucky 41017
Principal Investigator: Ivan Bedoya-Apraez
Phone: 513-761-4100
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 360-252-2500
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Fullerton, California 92835
Principal Investigator: David J Park
Phone: 321-843-8370
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Gettysburg, Pennsylvania 17325
Principal Investigator: Tina Khair
Phone: 717-334-4033
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
Gilbert, Arizona 85234
Principal Investigator: TOMISLAV DRAGOVICH
Phone: 480-256-6444
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Goodyear, Arizona 85338
Principal Investigator: Alan Tan
Phone: 623-207-3000
?
mi
from
Goodyear, AZ
Click here to add this to my saved trials
Green Bay, Wisconsin 54308
Principal Investigator: Michael Thompson
Phone: 513-761-4100
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Hollywood, Florida 33021
Principal Investigator: Jennifer Zikria
Phone: 360-252-2500
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Jacksonville, Florida
Principal Investigator: Robert Zaiden
Phone: 904-202-7300
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Lakeland, Florida 33805
Principal Investigator: Neeharika Makani
Phone: 863-687-1322
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
Longview, Texas 75601
Principal Investigator: Linda S. Couch
Phone: 210-595-5300
?
mi
from
Longview, TX
Click here to add this to my saved trials
1441 Eastlake Avenue
Los Angeles, California 90033
Principal Investigator: Heinz-Josef Lenz
Phone: 323-409-7148
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Joel Randolph Hecht
Phone: 310-794-1816
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
Principal Investigator: John T Hamm
Phone: 502-629-2500
?
mi
from
Louisville, KY
Click here to add this to my saved trials
529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
Principal Investigator: Adam A Rojan
Phone: 502-852-2891
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Midland, Texas 79701
Principal Investigator: David L Watkins
Phone: 903-579-9800
?
mi
from
Midland, TX
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Paul S Ritch
Phone: 414-805-2715
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Alexander Hindenburg
Phone: 516-663-2004
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Minneapolis, Minnesota 55408
Principal Investigator: Tim Larson
Phone: 206-448-4082
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: Johanna Chock Bendell
Sarah Cannon Cancer Center People who live with cancer
?
mi
from
Nashville, TN
Click here to add this to my saved trials
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Mark S Womack IV
Phone: 423-698-1844
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Newnan, Georgia 30265
Principal Investigator: Eyal Meiri
Phone: 770-400-6335
?
mi
from
Newnan, GA
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Hassan Hatoum
Phone: 918-619-4301
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
Principal Investigator: Sreeram Maddipatla
Phone: 360-252-2500
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32804
Principal Investigator: Ahmed Zakari
Phone: 407-303-2422
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Park Ridge, Illinois 60068
Principal Investigator: Edward James
Phone: 360-252-2500
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19124
Principal Investigator: Ankur Parikh
Phone: 360-252-2500
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
625 North 6th Street
Phoenix, Arizona 85013
Principal Investigator: Emad A Elquza
Phone: 520-694-2873
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
Principal Investigator: Nathan Bahary
Phone: 412-623-4881
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plano, Texas 75075
Principal Investigator: Carlos A Taboada
Phone: 903-579-9800
?
mi
from
Plano, TX
Click here to add this to my saved trials
Redondo Beach, California 90277
Principal Investigator: Hugo Hool
Phone: 310-750-3300
?
mi
from
Redondo Beach, CA
Click here to add this to my saved trials
Richmond, Virginia 23235
Principal Investigator: Seaborn M. Wade
Phone: 804-285-4846
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Principal Investigator: Ignacio Garrido Laguna
Phone: 801-581-3565
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Scarborough, Maine 04074
Principal Investigator: Matthew Dugan
Phone: 207-729-1148
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
Spokane, Washington 99208
Principal Investigator: Arvind Chaudhry
Phone: 509-462-2273
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Summit, New Jersey 07901
Principal Investigator: William T DeRosa
Phone: 908-522-8324
?
mi
from
Summit, NJ
Click here to add this to my saved trials
Sydney, New South Wales
Principal Investigator: Lorraine Chantrill
Phone: 6193555655
?
mi
from
Sydney,
Click here to add this to my saved trials
Tacoma, Washington 98002
Principal Investigator: Blair Irwin
Phone: 253-403-7249
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
721 Clinic Drive
Tyler, Texas 75701
Principal Investigator: Arielle Lee
Phone: 206-448-4082
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Tyler, Texas 75702
Principal Investigator: Donald A Richards
Phone: 903-579-9800
?
mi
from
Tyler, TX
Click here to add this to my saved trials
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Michael Jon Pishvaian
Phone: 2026871506
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
?
mi
from
Washington,
Click here to add this to my saved trials
Wichita Falls, Texas 76310
Principal Investigator: Brian Kent Ulrich
Phone: 9406918271
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Principal Investigator: Heather H Shearer
Phone: 206-448-4082
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01655
Principal Investigator: Venu Bathini
Phone: 505-856-0056
?
mi
from
Worcester, MA
Click here to add this to my saved trials