Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (Sequoia)
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer
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
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
Experimental
Active Comparator
Pegilodecakin + FOLFOX
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.
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.