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

Pancreatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923921
• Other study ID #: 17158
• Secondary ID: J1L-AM-JZGBAM001
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2017
• Est. completion date: March 5, 2020

Study information

• Verified date: April 15, 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: March 5, 2020
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• Pegilodecakin
Pegilodecakin plus FOLFOX

Drug:
• FOLFOX
FOLFOX Alone

Locations

Country	Name	City	State
Australia	Warringal Private Hospital	Heidelberg	Victoria
Australia	Cabrini Hospital Malvern	Malvern	Victoria
Australia	St John of God Murdoch Hospital	Murdoch	Western Australia
Australia	St Vincent's Hospital	Sydney	New South Wales
Austria	Universitätsklinikum Graz	Graz	Steiermark
Austria	KH der Barmherzigen Schwestern Linz BetriebsGesmbH	Linz	Oberösterreich
Austria	Universitätsklinikum Salzburg	Salzburg
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	Hospital Universitaire Erasme Brussel	Brussel
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Grand Hopital de Charleroi-Site Notre-Dame	Charleroi
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	AZ Groeninge	Kortrijk
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Belgium	Clinique St Elisabeth Namur	Namur
Belgium	CHU Dinant Godinne - UCL Namur	Yvoir
Canada	McGill University	Montreal	Quebec
Canada	Toronto Sunnybrook Regional Cancer Center	Toronto	Ontario
France	CHU de Besancon Hopital Jean Minjoz	Besancon Cedex
France	Hopital de la Pitie Salpetriere	Paris CEDEX 13
France	CHU la Miletrie	Poitiers
France	Hôpital Nord Franche-Comté	Trevenans
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	St Josef-Hospital Bochum	Bochum
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Kliniken Essen-Mitte Ev. Huyssens-Stiftung	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Asklepios Klinik Altona	Hamburg
Germany	Städtisches Klinikum München	München	Bayern
Italy	Ospedale le Torrette	Ancona
Italy	Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro	Candiolo	Torino
Italy	Azienda Ospedaliera Universitaria Ospedale San Martino di Genova	Genova
Italy	Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori	Meldola	Forli
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Ospedale Niguarda Ca Granda	Milano
Italy	AOU dell'Università degli Studi della Campania Luigi Vanvitelli	Naples
Italy	Istituto Oncologico Veneto	Padova
Italy	Policlinico San Matteo	Pavia
Italy	Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia	Reggio Emilia
Italy	Universita Campus Biomedico	Roma
Korea, Republic of	Dong-A University Medical Center	Busan	Busan Gwang'yeogsi
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeonnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Korea
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Korea
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Korea
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg	Poznan
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Wojewodzki Szpital Zespolony	Torun
Spain	Hospital General Universitario Alicante	Alicante
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Germans Trias i Pujol	Barcelona
Spain	Hospital General Yague	Burgos
Spain	C.H. Regional Reina Sofia	Córdoba
Spain	Hospital Duran I Reynals	Hospitaled DE Llobre	Barcelona
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Regional University Hospital in Malaga	Malaga
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	La Coruna
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Taiwan	Tri-Service General Hospital	Neihu Taipei
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Hammersmith Hospital	Acton	London
United Kingdom	Addenbrookes Hospital	Cambridge	Cambridgeshire
United Kingdom	Velindre Hospital	Cardiff	South Glamorgan
United Kingdom	Guys/St. Thomas Hospital	London	Surrey
United Kingdom	University College London Hospital Foundation Trust	London	Surrey
United States	Northeast Georgia Cancer Care, LLC	Athens	Georgia
United States	Texas Oncology-Austin Midtown	Austin	Texas
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	Lynn Cancer Institute Ctr for Hem-Onc	Boca Raton	Florida
United States	Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB	Boston	Massachusetts
United States	St Louis Cancer Care	Bridgeton	Missouri
United States	Saint Alphonsus Regional Medical Center	Caldwell	Idaho
United States	Gabrail Cancer Center	Canton	Ohio
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	North Shore Hematology Oncology Associates	East Setauket	New York
United States	St. Elizabeth Medical Center	Edgewood	Kentucky
United States	Fort Wayne Oncology & Hematology	Fort Wayne	Indiana
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Cancer Treatment Centers of America	Goodyear	Arizona
United States	Aurora West Allis Medical Center	Green Bay	Wisconsin
United States	Memorial Regional Hospital/Joe Dimaggio Childrens Hospital	Hollywood	Florida
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Watson Clinic	Lakeland	Florida
United States	TRIO - Translational Research in Oncology-US, Inc.	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	USC Norris Cancer Hospital	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute SCRI	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Southeastern Regional Medical Center	Newnan	Georgia
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	UF Health Cancer Center- Orlando Health	Orlando	Florida
United States	Eastern Regional Medical Center	Philadelphia	Pennsylvania
United States	University of Arizona Cancer Center	Phoenix	Arizona
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Texas Oncology-Plano East	Plano	Texas
United States	Oregon Health and Science University	Portland	Oregon
United States	Cancer Care Associates Medical Group	Redondo Beach	California
United States	Virginia Cancer Institute	Richmond	Virginia
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Texas Oncology - San Antonio Medical Center	San Antonio	Texas
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	New England Cancer Specialists - Scarborough	Scarborough	Maine
United States	Medical Oncology Associates, PS	Spokane	Washington
United States	Summit Medical Group	Summit	New Jersey
United States	MultiCare Regional Cancer Center - Auburn	Tacoma	Washington
United States	US Oncology	The Woodlands	Texas
United States	Hope Cancer Center of East Texas	Tyler	Texas
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Texas Oncology-Wichital Falls Texoma Cancer Center	Wichita Falls	Texas
United States	Novant Health, Oncology Research Institute	Winston-Salem	North Carolina
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ARMO BioSciences

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Randomization to date of death from any cause (Up To 30 Months)
Secondary	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.	Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Secondary	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.	Randomization to PD (Up To 30 Months)
Secondary	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.	Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)
Secondary	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.	Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Secondary	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.	From randomization to until the date of first documented date of death from any cause within 12 months