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Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer (Sequoia)

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ClinicalTrials.gov Identifier: NCT02923921
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
ARMO BioSciences

Brief Summary:
To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer as measured by overall survival

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: AM0010 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 AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 566 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 Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
Study Start Date : November 2016
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARM 1
AM0010 (5 μg/kg) dosed on Days 1-5 and Days 8-12 SQ plus 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 or until disease progression.
Biological: AM0010
AM0010 plus FOLFOX

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

Active Comparator: ARM 2
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 or until disease progression.
Drug: FOLFOX
FOLFOX Alone
Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months after the last patient randomized ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 36 months after the last patient randomized ]
  2. Objective Response Rate [ Time Frame: 36 months after the last patient randomized ]


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. Patient 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. Patient must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
  6. Patients must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
  7. Patients 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. Patient 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. Patient has received prior treatment with AM0010 or fluoropyrimidine/platinum containing regimen
  4. Patients 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. Patients 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


Contacts
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Contact: Study Director 650-771-9325 AM0010-301@armobio.com

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Locations
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United States, Alabama
Alabama Oncology Recruiting
Birmingham, Alabama, United States, 35205
Contact: Brittany White    205-263-9746      
Principal Investigator: Shaily Lakhanpal, MD         
United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Charlotte Tsinnijinnie    480-256-3116      
Principal Investigator: Tomislav Dragovich, MD         
Cancer Treatment Centers of America Recruiting
Goodyear, Arizona, United States, 85338
Contact: Lisa Blaydorn    623-207-3183      
Principal Investigator: Alan Tan, MD         
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85719
Contact: Gloria Rippe    520-694-9049      
Principal Investigator: Emad Elquza, MD         
United States, California
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Sudha Dara    661-616-1619      
Principal Investigator: Kota Shekar, MD         
St. Joseph Heritage Healthcare Recruiting
Fullerton, California, United States, 92835
Contact: Genet Sisay    714-992-3000 ext 4511      
Principal Investigator: David J Park, MD         
Los Angeles Hematology Oncology Medical Group Withdrawn
Los Angeles, California, United States, 90017
USC Norris Comprehensive Care Center (NCCC) Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Wallman    310-865-3124      
Principal Investigator: Heinz-Josef Lenz, MD         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90094
Contact: Msgana Tamrat    310-633-8400 ext 20109      
Principal Investigator: Joel Hecht, MD         
Cancer Care Associates Medical Group, Inc Recruiting
Redondo Beach, California, United States, 90277
Contact: Sherry Hutcherson    310-750-3376      
Principal Investigator: Hugo Hool, MD         
Pacific Central Coast Health Centers San Luis Obispo Oncology and Hematology Health Center Recruiting
San Luis Obispo, California, United States, 93401
Contact: Lee Walton    805-543-5577 ext 123      
Principal Investigator: Brian DiCarlo, MD         
Central Coast Medical Oncology Corporation Recruiting
Santa Maria, California, United States, 93454
Contact: Maria Mejia    805-346-3462      
Principal Investigator: Robert Dichmann, MD         
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Aurora, Colorado, United States, 80012
Contact: Bobbie Donnachaidh    303-930-5515      
Principal Investigator: Sujatha Nallapareddy, MD         
United States, Connecticut
Smilow Cancer Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Christina Wiess    203-737-3472      
Principal Investigator: Jill Lacy, MD         
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Principal Investigator: Michael Pishvaian, MD         
United States, Florida
Lynn Cancer Institute Withdrawn
Boca Raton, Florida, United States, 33486
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Kimberly Brown    954-844-9132      
Principal Investigator: Jennifer Zikria, MD         
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Cathy Gonzales    904-202-7319      
Principal Investigator: Robert Zaiden, MD         
Cancer Specialists, LLC Recruiting
Jacksonville, Florida, United States, 32256
Contact: Jenni Bachhofer    904-363-7462 ext 1179      
Principal Investigator: Miten Patel, MD         
Watson Clinic Center For Research Inc Recruiting
Lakeland, Florida, United States, 33805
Contact: Adrienne Haines-Adams    863-904-2482      
Principal Investigator: Neeharika Makani, MD         
Revival Research Withdrawn
Miami, Florida, United States, 33173
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Ingrid Acker    407-303-5871      
Principal Investigator: Ahmed Zakari, MD         
UF Health Cancer Center of Orlando Health Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Sreeram Maddipatla, MD         
United States, Georgia
University Cancer and Blood Center, LLC Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie Hodgson    706-353-2990 ext 279      
Principal Investigator: Petros Nikolinakos, MD         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Tina Schied    208-367-3481      
Principal Investigator: Kerry Pulver, MD         
United States, Illinois
Illinois Cancer Specialists (Arlington Heights) Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Andrea Gidden    847-259-6406      
Principal Investigator: Richard Siegel, MD         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Jennifer Mose    217-876-4765      
Principal Investigator: James L. Wade, MD         
Advocate Medical Group - Park Ridge, Luther Lane - Oncology Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Belkis Gaviria    847-410-0659      
Principal Investigator: Edward James, MD         
Healthcare Research Network Recruiting
Tinley Park, Illinois, United States, 60487
Contact: Mina Boyadzhieva    708-745-9971      
Principal Investigator: Subramanya Rao, MD         
United States, Indiana
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Kristy Crisp    260-969-7818      
Principal Investigator: Sunil Babu, MD         
United States, Kentucky
St. Elizabeth Medical Center Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Sara Browne    859-301-4000      
Principal Investigator: Ivan Bedoya-Aparez, MD         
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Karen Ellis    502-562-3462      
Principal Investigator: Adam Rojan, MD         
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Lauren Zutt    502-629-3589      
Principal Investigator: John Hamm, MD         
United States, Louisiana
Hematology Oncology Clinic Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Evie Key    225-761-3951      
Principal Investigator: Gerald P Miletello, MD         
United States, Maine
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
Contact: Lindsay St. Louis    207-396-8587      
Principal Investigator: Matthew C Dugan, DO         
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
Contact: Jennifer Cipriano    240-482-0556      
Principal Investigator: Ralph V. Boccia, MD         
University of Maryland St. Joseph Medical Center, The Cancer Institute Recruiting
Towson, Maryland, United States, 21204
Contact: Elizabeth Yakim    410-427-2571      
Principal Investigator: Yousuf Gaffar, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sarah Kim    617-975-7409      
Principal Investigator: Andrea Bullock, MD         
University of Massachusetts Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Cara Gregoire    508-865-2024      
Principal Investigator: Venu Bathini, MD         
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Kathryn Gruetzman    763-236-0814      
Principal Investigator: Timothy Larson, MD         
United States, Missouri
St. Louis Cancer Care Recruiting
Bridgeton, Missouri, United States, 63044
Contact: Kelli Martin    314-291-3312      
Principal Investigator: Juan Cuevas, MD         
United States, New Jersey
Summit Medical Group Recruiting
Morristown, New Jersey, United States, 07960
Contact: Michelle Mackenzie    973-436-1755      
Principal Investigator: William DeRosa, DO         
United States, New York
North Shore Hematology Oncology Associates Recruiting
East Setauket, New York, United States, 11733
Contact: Fred Parrish    631-675-5143      
Principal Investigator: David Chu, MD         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Dawn Tsushima    516-663-4895      
Principal Investigator: Alexander Hindenburg, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ireka Burrus    919-668-1861      
Principal Investigator: Niharika Mettu, MD         
Novant Health Oncology Specialists Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Debbie Carr    336-718-8481      
Principal Investigator: Heather Shearer, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Meghan Curry    330-492-3345 ext 207      
Principal Investigator: Nashat Y. Gabrail, MD         
Oncology Hematology Care, Inc Recruiting
Cincinnati, Ohio, United States, 45230
Contact: Kim Brockman    513-751-2273 ext 12910      
Principal Investigator: Mark Johns, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Aletha Ticer    405-271-8001 ext 48514      
Principal Investigator: Hassan Hatoum, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Anne Fahlman    503-494-3175      
Principal Investigator: Charles Lopez, MD         
United States, Pennsylvania
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Vanessa Hardman    717-334-4033 ext 141      
Principal Investigator: Tina Khair, DO         
Eastern Regional Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Rosanne Clayton    215-537-5971      
Principal Investigator: Ankur Parikh, DO         
Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Heather Taylor    412-235-1324      
Principal Investigator: Nathan Bahary, MD         
United States, Tennessee
Erlanger Health System Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Jill Metcalf    423-778-2982      
Principal Investigator: Robert Graham, MD         
Tennessee Oncology Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Tiffany Cason    423-242-2858      
Principal Investigator: Mark Womack, MD         
SCRI Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Scott Marx    615-524-4161      
Principal Investigator: Johanna Bendell, MD         
United States, Texas
Texas Oncology - Austin Central Recruiting
Austin, Texas, United States, 78705
Contact: Jessica McClain    512-421-4100      
Principal Investigator: Vivian Cline-Burkhardt, MD         
Texas Oncology-Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Julie Morehouse    214-370-1238      
Principal Investigator: Carlos Becerra, MD         
Texas Oncology - Midland Allison Cancer Center Recruiting
Midland, Texas, United States, 79701
Contact: Mary Williams    432-687-1949      
Principal Investigator: David Watkins, MD         
Texas Oncology - Plano East Recruiting
Plano, Texas, United States, 75075
Contact: Kristy Lee    972-867-3577      
Principal Investigator: Carlos Taboada, MD         
Texas Oncology - San Antonio Medical Center Recruiting
San Antonio, Texas, United States, 78240
Contact: Christine Smith    210-955-3300      
Principal Investigator: Linda Couch, MD         
HOPE Cancer Center of East Texas Recruiting
Tyler, Texas, United States, 75701
Contact: Perla Lopez    903-595-7041      
Principal Investigator: Arielle Lee, MD         
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Penny Watkins    903-579-9899      
Principal Investigator: Donald Richards, MD         
Texas Oncology - Webster Recruiting
Webster, Texas, United States, 77598
Contact: Tara Gray    281-332-7505      
Principal Investigator: Anish Meerasahib, MD         
Texas Oncology - Witchita Falls Texoma Cancer Center Recruiting
Wichita Falls, Texas, United States, 76310
Contact: Peggy Gales    940-691-8271      
Principal Investigator: Brian Ulrich, MD         
United States, Utah
Huntsman Cancer Institute at The University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Ignacio Garrido-Laguna, MD         
United States, Virginia
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23230
Contact: Hannah Crews    804-288-7159      
Principal Investigator: Seaborn Wade, MD         
United States, Washington
Medical Oncology Associates Recruiting
Spokane, Washington, United States, 99208
Contact: Monika Chaudhry    509-462-2273      
Principal Investigator: Arvind Chaudhry, MD         
MultiCare Regional Cancer Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Samantha Carini    253-403-1269      
Principal Investigator: Blair Iwrin, MD         
United States, Wisconsin
Froedtert and The Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Barb Dion    414-805-4639      
Principal Investigator: Paul Ritch, MD         
Aurora Research Institute LLC Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Kyle Crivello    414-778-4345      
Principal Investigator: Michael Thompson, MD         
Australia
St Vincents Hospital Sydney Recruiting
Darlinghurst, Australia, 2010
Contact: Lalith Ratnayake    +61293555615      
Principal Investigator: Lorraine Chantrill, MD         
Warringal Private Hospital Recruiting
Heidelberg, Australia, 3084
Contact: Dave McArdle         
Principal Investigator: Niall Tebbutt, MD         
Cabrini Hospital Recruiting
Malvern, Australia, 3144
Contact: Melissa Groom         
Principal Investigator: Jeremy Shapiro, MD         
St John of God Murdoch Hospital Recruiting
Murdoch, Australia, 6150
Contact: Janice Woo         
Principal Investigator: Kynan Feeney, MD         
Austria
Medizinische Universität Graz Recruiting
Graz, Austria, 8036
Contact: Lisa Jaritz         
Principal Investigator: Herbert Stoger, MD         
Ordensklinikum Linz, Krankenhaus der Barmherzigen Recruiting
Linz, Austria, 4020
Contact: Angie Plasser         
Principal Investigator: Franz Romeder, MD         
Salzburger Landeskliniken Recruiting
Salzburg, Austria, 5020
Contact: Michaela Schachner         
Principal Investigator: Richard Greil, MD         
Belgium
Imelda GI Clinical Research Center Recruiting
Bonheiden, Belgium, 2820
Contact: Doreen Iwens    +3215504710      
Principal Investigator: Pieter-Jan Cuyle, MD         
Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Axelle Ghilain    +3225554455      
Principal Investigator: Jean-Luc Van Laethem, MD         
UZ Brussels Recruiting
Brussels, Belgium, 1090
Contact: Alex Dewaele         
Principal Investigator: Leen Vanacker, MD         
Grand Hopital de Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Mélanie Gilet         
Principal Investigator: Jean-Luc Canon, MD         
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Peggy De Clercq         
Principal Investigator: Marc Peeters, MD         
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Tine Derre    +3293325125      
Principal Investigator: Stéphanie Laurent, MD         
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Fien Verplancke         
Principal Investigator: Philippe Vergauwe, MD         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Jenus Vermeersch    +3216342815      
Principal Investigator: Eric Van Cutsem, MD         
CMSE Namur Recruiting
Namur, Belgium, 5000
Contact: Bénédicte Hyernaux         
Principal Investigator: Jean-Charles Goeminne, MD         
CHU UCL Namur asbl - Site Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Cossette Sanchez         
Principal Investigator: Lionel D'Hondt, MD         
Canada
Centre Hospitalier de l'Universite de Montreal Recruiting
Montréal, Canada, H2X 3J4
Contact: Stephanie Girard    514-890-8000 ext 35281      
Principal Investigator: Richard Letourneau, MD         
McGill University Health Center Recruiting
Montréal, Canada, H4A 3J1
Contact: Jasra Shweta    514-934-1934 ext 34905      
Principal Investigator: Jamil Asselah, MD         
Sunnybrook Research Institute - University of Toronto Recruiting
Toronto, Canada, M4N 3M5
Contact: Kate Besel    416-480-5000 ext 7868      
Principal Investigator: Yoo Joung Ko, MD         
France
Hopital Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Joelle Babre         
Principal Investigator: Stefano Kim, MD         
Hopital prive Jean Mermoz Recruiting
Lyon, France, 69008
Contact: Gaëlle Le Guludec         
Principal Investigator: Pascal Artu, MD         
Groupe Hospitalier Pitié Salpétrière Recruiting
Paris, France, 75651
Contact: Katia Raab         
Principal Investigator: Jean Baptiste Bachet, MD         
CHRU de Poitiers La Miletrie Recruiting
Poitiers, France, 86021
Contact: Christina Gabard         
Principal Investigator: David Tougeron, MD         
Hôpital Nord Franche-Comté Recruiting
Trevenans, France, 25200
Contact: Fanny Sarrazin         
Principal Investigator: Stefano Kim, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Carine Gueugnon         
Principal Investigator: Pascal Burtin         
Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Isabell Gruettner         
Principal Investigator: Uwe Pelzer, MD         
St. Josef Hospital GmbH Recruiting
Bochum, Germany, 44791
Contact: Ayleen Bartels         
Principal Investigator: Anke Reinacher-Schick, MD         
Universitätsklinikum Carl Gustav Carus an der TU Dresden Recruiting
Dresden, Germany
Contact: Evelyn Franke         
Principal Investigator: Gunnar Folprecht, MD         
Kliniken Essen Mitte Recruiting
Essen, Germany, 45136
Contact: Thea Resch         
Principal Investigator: Sven Dyrda, MD         
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Melanie Höfflin         
Principal Investigator: Steffen Heeg, MD         
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Kay Henning         
Principal Investigator: Dirk Arnold, MD         
Klinikum Neuperlach Recruiting
München, Germany
Contact: Regine Biedenkopf         
Principal Investigator: Meinolf Karthaus, MD         
Universitatsklinikum Tubingen Recruiting
Tübingen, Germany
Contact: Ursula Koppenhöfer         
Principal Investigator: Michael Bitzer, MD         
Ireland
Tallaght Hospital Recruiting
Dublin, Ireland
Contact: Ashley Bazin         
Principal Investigator: Raymond McDermott, MD         
University Hospital Galway Recruiting
Galway, Ireland
Principal Investigator: Gregory D Leonard, MD         
University Hospital Waterford Recruiting
Waterford, Ireland
Contact: Helena Dwyer         
Principal Investigator: Anne Horgan, MD         
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Recruiting
Ancona, Italy, 60020
Contact: Michela Burattini         
Principal Investigator: Rossana Berardi, MD         
Fondazione del Piemonte per l'Oncologia Recruiting
Candiolo, Italy, 10060
Contact: Celeste Cagnazzo         
Principal Investigator: Massimo Aglietta, MD         
IRCCS Azienda Ospedaliera Universitaria San Martino Istituto Nazionale Per La Ricerca Sul Cancro Recruiting
Genova, Italy, 16132
Contact: Carla Curti         
Principal Investigator: Alberto Sobrero, MD         
Istituto Scientifico Romagnolo Per Lo Studio Recruiting
Meldola, Italy, 47014
Contact: Flavia Pagan         
Principal Investigator: Giovanni Frassineti, MD         
Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Contact: Caterina Riccio         
Principal Investigator: Luca Gianni, MD         
ASST Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Italy, 20162
Principal Investigator: Salvatore Siena, MD         
Azienda Ospedaliero Universitaria Seconda Università Degli Studi Di Napoli Recruiting
Napoli, Italy, 80131
Contact: Vincenzo Mario Famiglietti         
Principal Investigator: Fortunato Ciardiello, MD         
Istituto Oncologico Veneto - I.R.C.C.S. Recruiting
Padua, Italy, 35128
Contact: Angelo Claudio Palozzo         
Principal Investigator: Sara Lonardi, MD         
Fondazione IRCCS Policlinico San Matteo di Pavia Recruiting
Pavia, Italy, 27100
Contact: Rosanna Sabato         
Principal Investigator: Silvia Brugnatelli, MD         
Arcispedale Santa Maria Nuova Recruiting
Reggio Emilia, Italy, 42123
Contact: Erika Gervasi         
Principal Investigator: Michele Panebianco, MD         
Policlinico Universitario Campus Biomedico Di Roma Recruiting
Roma, Italy, 00128
Contact: Teresa Grassani         
Principal Investigator: Giuseppe Tonini, MD         
Istituto Clinico Humanitas Active, not recruiting
Rozzano, Italy, 20089
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 602715
Contact: Jeong Mi Choi         
Principal Investigator: Sung Yung Oh, MD         
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Korea, Republic of, 58128
Contact: Ji Hyun Moon         
Principal Investigator: Ik Joo Chung, MD         
Severance Hospital at Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: Hwa Young Lee         
Principal Investigator: Hye Jin Choi, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Eunhye Jang         
Principal Investigator: Baek-yeol Ryoo, MD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Hyun Ah Kim         
Principal Investigator: Joon Ho Park, MD         
The Catholic University of Korea, Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Hyunjoo An         
Principal Investigator: Myung-Ah Lee, MD         
Poland
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii Recruiting
Gdańsk, Poland, 80-129
Contact: Joanna Karczewska         
Principal Investigator: Joanna Wojcik-Tomaszewska, MD         
Uniwersyteckie Centrum Kliniczne - PPDS Recruiting
Gdańsk, Poland, 80-952
Contact: Anna Gladysz         
Principal Investigator: Jacek Jassem, MD         
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu Recruiting
Poznań, Poland, 60-569
Contact: Klaudia Wesolowska         
Principal Investigator: Rodryg Ramlau, MD         
Centrum Medyczne Mrukmed Recruiting
Rzeszów, Poland, 35-021
Contact: Michal Hapka         
Principal Investigator: Andrzej Mruk, MD         
Wojewodzki Szpital Zespolony Im L Rydygiera Recruiting
Toruń, Poland, 87-100
Principal Investigator: Piotr Sawrycki, MD         
Spain
Hospital Universitario A Coruña Recruiting
A Coruña, Spain, 15006
Contact: Vanessa Sanchez         
Principal Investigator: Begoña Graña Suarez, MD         
Hospital General Universitario de Alicante Recruiting
Alicante, Spain, 03010
Contact: Rosa Ana Montoyo         
Principal Investigator: Bartomeu Massuti, MD         
Hospital Universitario Germans Trias i Pujol Recruiting
Badalona, Spain, 08916
Contact: Sonia Piñer         
Principal Investigator: Laura Layos, MD         
Hospital de La Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Merce Garcia Belinchon         
Principal Investigator: Marta Martin, MD         
Hospital Universitario Vall d'Hebron - PPDS Recruiting
Barcelona, Spain, 08035
Contact: Sandra Tijeras Perez         
Principal Investigator: Teresa Macarulla Mercade, MD         
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Teresa Vilella         
Principal Investigator: Joan Maurel Santasusana, MD         
ICO L'Hospitalet Recruiting
Barcelona, Spain, 08908
Contact: Josefina Rivera Alonso         
Principal Investigator: Berta Laquente, MD         
C.A.U de Burgos- Hospital Universitario de Burgos Recruiting
Burgos, Spain, 09006
Contact: Clara De Pablo Delgado         
Principal Investigator: Carlos Garcia Giron, MD         
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Jacinta Marin Serrano         
Principal Investigator: Maria Teresa Cano Osuna, MD         
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Spain, 28942
Contact: Ana Lopez Ibañez         
Principal Investigator: Laura Medina, MD         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Ines Perez         
Principal Investigator: Andres Munoz, MD         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Cristina Carrera         
Principal Investigator: Mercedes Rodriguez Garrote, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Martina Giuppi         
Principal Investigator: Rocío García Carbonero, MD         
Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Marina Rabadan         
Principal Investigator: Antonio Cubillo Gracián, MD         
Hospital Regional Universitario de Malaga - Hospital General Recruiting
Málaga, Spain, 29010
Contact: Sabrina López         
Principal Investigator: Inmaculada Ales, MD         
Hospital Clinico Universitario de Santiago Recruiting
Santiago de Compostela, Spain, 15706
Contact: Cristina Blanco         
Principal Investigator: Rafael Lopez, MD         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Elena Brehcist         
Principal Investigator: Manuel Valladares, MD         
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Lee Yi-Nan         
Principal Investigator: Yan-Shen Shan, MD         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Abby Yeh    +886228712121 ext 2935      
Principal Investigator: Ching-Pin Li, MD         
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 11490
Contact: Lynn Chen         
Principal Investigator: De-Chuan Chen, MD         
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB20QQ
Contact: Emma Wong         
Principal Investigator: Pippa Corrie, MD         
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Janet Douglass         
Principal Investigator: Russell Petty, MD         
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: Sara Huff         
Principal Investigator: Debashis Sarker, MD         
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Emily Pickford         
Principal Investigator: Harpreet Wasan, MD         
University College London Recruiting
London, United Kingdom, WC1E 6DD
Contact: Gemma Hector         
Principal Investigator: John Bridgewater, MD         
Velindre Hospital Recruiting
Whitchurch, United Kingdom, CF14 2TL
Contact: Amanda Jackson         
Principal Investigator: Kein Yim, MD         
Sponsors and Collaborators
ARMO BioSciences

Layout table for additonal information
Responsible Party: ARMO BioSciences
ClinicalTrials.gov Identifier: NCT02923921     History of Changes
Other Study ID Numbers: AM0010-301
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Antineoplastic Agents