Sequoia: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pegilodecakin + 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. |
Biological: Pegilodecakin
Pegilodecakin plus FOLFOX
Other Names:
Drug: FOLFOX
FOLFOX Alone
Other Names:
|
Active Comparator: FOLFOX 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. |
Drug: FOLFOX
FOLFOX Alone
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Randomization to date of death from any cause (Up To 30 Months)]
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 [Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)]
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 [Randomization to PD (Up To 30 Months)]
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) [Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)]
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) [Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)]
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) [From randomization to until the date of first documented date of death from any cause within 12 months]
The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
2 | Cancer Treatment Centers of America | Goodyear | Arizona | United States | 85338 |
3 | University of Arizona Cancer Center | Phoenix | Arizona | United States | 85004 |
4 | Comprehensive Blood and Cancer Center | Bakersfield | California | United States | 93309 |
5 | St. Joseph Heritage Healthcare | Fullerton | California | United States | 92935 |
6 | USC Norris Cancer Hospital | Los Angeles | California | United States | 90033 |
7 | TRIO - Translational Research in Oncology-US, Inc. | Los Angeles | California | United States | 90095 |
8 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
9 | Cancer Care Associates Medical Group | Redondo Beach | California | United States | 90277 |
10 | Central Coast Medical Oncology Corporation | Santa Maria | California | United States | 93454 |
11 | Rocky Mountain Cancer Center | Denver | Colorado | United States | 80218 |
12 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
13 | Lynn Cancer Institute Ctr for Hem-Onc | Boca Raton | Florida | United States | 33486 |
14 | Memorial Regional Hospital/Joe Dimaggio Childrens Hospital | Hollywood | Florida | United States | 33021 |
15 | Baptist Cancer Institute | Jacksonville | Florida | United States | 32207 |
16 | Watson Clinic | Lakeland | Florida | United States | 33805 |
17 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
18 | UF Health Cancer Center- Orlando Health | Orlando | Florida | United States | 32806 |
19 | Northeast Georgia Cancer Care, LLC | Athens | Georgia | United States | 30607 |
20 | Southeastern Regional Medical Center | Newnan | Georgia | United States | 30265 |
21 | Saint Alphonsus Regional Medical Center | Caldwell | Idaho | United States | 83605 |
22 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
23 | Fort Wayne Oncology & Hematology | Fort Wayne | Indiana | United States | 46815 |
24 | St. Elizabeth Medical Center | Edgewood | Kentucky | United States | 41017 |
25 | Norton Cancer Institute | Louisville | Kentucky | United States | 40202 |
26 | Hematology Oncology Clinic | Baton Rouge | Louisiana | United States | 70808 |
27 | New England Cancer Specialists - Scarborough | Scarborough | Maine | United States | 04074 |
28 | Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB | Boston | Massachusetts | United States | 02215 |
29 | University of Massachusetts Medical Center | Worcester | Massachusetts | United States | 01655 |
30 | Virginia Piper Cancer Institute | Minneapolis | Minnesota | United States | 55407 |
31 | St Louis Cancer Care | Bridgeton | Missouri | United States | 63044 |
32 | Summit Medical Group | Summit | New Jersey | United States | 07902 |
33 | North Shore Hematology Oncology Associates | East Setauket | New York | United States | 11733 |
34 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
35 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
36 | Novant Health, Oncology Research Institute | Winston-Salem | North Carolina | United States | 27103 |
37 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
38 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73190 |
39 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
40 | Gettysburg Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
41 | Eastern Regional Medical Center | Philadelphia | Pennsylvania | United States | 19124 |
42 | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232-1305 |
43 | Sarah Cannon Research Institute SCRI | Nashville | Tennessee | United States | 37203 |
44 | Tennessee Oncology PLLC | Nashville | Tennessee | United States | 37203 |
45 | Texas Oncology-Austin Midtown | Austin | Texas | United States | 78705 |
46 | Texas Oncology-Plano East | Plano | Texas | United States | 75075 |
47 | Texas Oncology - San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
48 | US Oncology | The Woodlands | Texas | United States | 77380 |
49 | Hope Cancer Center of East Texas | Tyler | Texas | United States | 75701 |
50 | Texas Oncology - Tyler | Tyler | Texas | United States | 75702 |
51 | Texas Oncology-Wichital Falls Texoma Cancer Center | Wichita Falls | Texas | United States | 76310 |
52 | University of Utah School of Medicine | Salt Lake City | Utah | United States | 84132 |
53 | Virginia Cancer Institute | Richmond | Virginia | United States | 23230 |
54 | Medical Oncology Associates, PS | Spokane | Washington | United States | 99208 |
55 | MultiCare Regional Cancer Center - Auburn | Tacoma | Washington | United States | 98002 |
56 | Aurora West Allis Medical Center | Green Bay | Wisconsin | United States | 54308 |
57 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
58 | St Vincent's Hospital | Sydney | New South Wales | Australia | 2010 |
59 | Warringal Private Hospital | Heidelberg | Victoria | Australia | 3084 |
60 | Cabrini Hospital Malvern | Malvern | Victoria | Australia | 3144 |
61 | St John of God Murdoch Hospital | Murdoch | Western Australia | Australia | 6150 |
62 | KH der Barmherzigen Schwestern Linz BetriebsGesmbH | Linz | Oberösterreich | Austria | 4010 |
63 | Universitätsklinikum Graz | Graz | Steiermark | Austria | 8036 |
64 | Universitätsklinikum Salzburg | Salzburg | Austria | 5020 | |
65 | Imeldaziekenhuis | Bonheiden | Belgium | 2820 | |
66 | Hospital Universitaire Erasme Brussel | Brussel | Belgium | 1070 | |
67 | Universitair Ziekenhuis Brussel | Brussel | Belgium | 1090 | |
68 | Grand Hopital de Charleroi-Site Notre-Dame | Charleroi | Belgium | 6000 | |
69 | Universitair Ziekenhuis Antwerpen | Edegem | Belgium | 2650 | |
70 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
71 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
72 | Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | 3000 | |
73 | Clinique St Elisabeth Namur | Namur | Belgium | 5000 | |
74 | CHU Dinant Godinne - UCL Namur | Yvoir | Belgium | 5530 | |
75 | Toronto Sunnybrook Regional Cancer Center | Toronto | Ontario | Canada | M4N 3M5 |
76 | McGill University | Montreal | Quebec | Canada | H3A 1A1 |
77 | CHU de Besancon Hopital Jean Minjoz | Besancon Cedex | France | 25030 | |
78 | Hopital de la Pitie Salpetriere | Paris CEDEX 13 | France | 75651 | |
79 | CHU la Miletrie | Poitiers | France | 86021 | |
80 | Hôpital Nord Franche-Comté | Trevenans | France | 90400 | |
81 | Städtisches Klinikum München | München | Bayern | Germany | 81737 |
82 | Kliniken Essen-Mitte Ev. Huyssens-Stiftung | Essen | Nordrhein-Westfalen | Germany | 45136 |
83 | Universitätsklinikum Carl Gustav Carus | Dresden | Sachsen | Germany | 01307 |
84 | Charité Universitätsmedizin Berlin | Berlin | Germany | 13353 | |
85 | St Josef-Hospital Bochum | Bochum | Germany | ||
86 | Universitätsklinikum Freiburg | Freiburg | Germany | ||
87 | Asklepios Klinik Altona | Hamburg | Germany | 22763 | |
88 | Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori | Meldola | Forli | Italy | 47014 |
89 | Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro | Candiolo | Torino | Italy | |
90 | Ospedale le Torrette | Ancona | Italy | 60100 | |
91 | Azienda Ospedaliera Universitaria Ospedale San Martino di Genova | Genova | Italy | 16132 | |
92 | IRCCS Ospedale San Raffaele | Milano | Italy | 20132 | |
93 | Ospedale Niguarda Ca Granda | Milano | Italy | 20162 | |
94 | AOU dell'Università degli Studi della Campania Luigi Vanvitelli | Naples | Italy | ||
95 | Istituto Oncologico Veneto | Padova | Italy | 35128 | |
96 | Policlinico San Matteo | Pavia | Italy | 27100 | |
97 | Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia | Reggio Emilia | Italy | 42123 | |
98 | Universita Campus Biomedico | Roma | Italy | 00155 | |
99 | Dong-A University Medical Center | Busan | Busan Gwang'yeogsi | Korea, Republic of | 49201 |
100 | Chonnam National University Hwasun Hospital | Hwasun-gun | Jeonnam | Korea, Republic of | 519-809 |
101 | Severance Hospital Yonsei University Health System | Seoul | Korea | Korea, Republic of | 03722 |
102 | Samsung Medical Center | Seoul | Korea | Korea, Republic of | 06351 |
103 | Seoul St. Mary's Hospital | Seoul | Korea | Korea, Republic of | 06591 |
104 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
105 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-952 | |
106 | Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg | Poznan | Poland | 60-569 | |
107 | Centrum Medyczne Medyk | Rzeszow | Poland | 35-025 | |
108 | Wojewodzki Szpital Zespolony | Torun | Poland | 87-100 | |
109 | Hospital Duran I Reynals | Hospitaled DE Llobre | Barcelona | Spain | 08907 |
110 | Hospital Clinico Universitario de Santiago | Santiago de Compostela | La Coruna | Spain | 15706 |
111 | Hospital General Universitario Alicante | Alicante | Spain | 03010 | |
112 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
113 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
114 | Hospital Universitario Germans Trias i Pujol | Barcelona | Spain | ||
115 | Hospital General Yague | Burgos | Spain | 9005 | |
116 | C.H. Regional Reina Sofia | Córdoba | Spain | 14001 | |
117 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
118 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
119 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
120 | Hospital Madrid Norte Sanchinarro | Madrid | Spain | 28050 | |
121 | Regional University Hospital in Malaga | Malaga | Spain | 29011 | |
122 | Hospital Universitario Virgen del Rocio | Sevilla | Spain | 41013 | |
123 | Tri-Service General Hospital | Neihu Taipei | Taiwan | 11490 | |
124 | National Cheng Kung University Hospital | Tainan | Taiwan | 704 | |
125 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 | |
126 | Addenbrookes Hospital | Cambridge | Cambridgeshire | United Kingdom | CB2 0QQ |
127 | Hammersmith Hospital | Acton | London | United Kingdom | W12 0HS |
128 | Velindre Hospital | Cardiff | South Glamorgan | United Kingdom | CF14 2TL |
129 | University College London Hospital Foundation Trust | London | Surrey | United Kingdom | NW1 2BU |
130 | Guys/St. Thomas Hospital | London | Surrey | United Kingdom | SE1 9RT |
Sponsors and Collaborators
- Eli Lilly and Company
- ARMO BioSciences
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Publications
None provided.- 17158
- J1L-AM-JZGB
- AM0010-301
- 2016-003858-33
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment. |
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX |
---|---|---|
Arm/Group Description | Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing less than or equal to (≤) 80 kg or 0.8 mg for participants weighing greater than (>) 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. |
Period Title: Overall Study | ||
STARTED | 283 | 284 |
Received at Least 1 Dose of Study Drug | 278 | 251 |
Safety Population | 278 | 251 |
COMPLETED | 230 | 227 |
NOT COMPLETED | 53 | 57 |
Baseline Characteristics
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX | Total |
---|---|---|---|
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. | Total of all reporting groups |
Overall Participants | 283 | 284 | 567 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
63.8
(9.0)
|
64.1
(9.9)
|
64.0
(9.4)
|
Sex: Female, Male (Count of Participants) | |||
Female |
135
47.7%
|
132
46.5%
|
267
47.1%
|
Male |
148
52.3%
|
152
53.5%
|
300
52.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
9
3.2%
|
6
2.1%
|
15
2.6%
|
Not Hispanic or Latino |
263
92.9%
|
265
93.3%
|
528
93.1%
|
Unknown or Not Reported |
11
3.9%
|
13
4.6%
|
24
4.2%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
1
0.4%
|
0
0%
|
1
0.2%
|
Asian |
59
20.8%
|
55
19.4%
|
114
20.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.4%
|
1
0.2%
|
Black or African American |
8
2.8%
|
8
2.8%
|
16
2.8%
|
White |
207
73.1%
|
213
75%
|
420
74.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
8
2.8%
|
7
2.5%
|
15
2.6%
|
Region of Enrollment (Count of Participants) | |||
United States |
93
32.9%
|
89
31.3%
|
182
32.1%
|
United Kingdom |
5
1.8%
|
4
1.4%
|
9
1.6%
|
Spain |
42
14.8%
|
31
10.9%
|
73
12.9%
|
Canada |
2
0.7%
|
7
2.5%
|
9
1.6%
|
South Korea |
48
17%
|
41
14.4%
|
89
15.7%
|
Austria |
3
1.1%
|
10
3.5%
|
13
2.3%
|
Belgium |
17
6%
|
19
6.7%
|
36
6.3%
|
Taiwan |
5
1.8%
|
10
3.5%
|
15
2.6%
|
Poland |
8
2.8%
|
5
1.8%
|
13
2.3%
|
Italy |
28
9.9%
|
39
13.7%
|
67
11.8%
|
France |
9
3.2%
|
2
0.7%
|
11
1.9%
|
Australia |
14
4.9%
|
16
5.6%
|
30
5.3%
|
Germany |
9
3.2%
|
11
3.9%
|
20
3.5%
|
Outcome Measures
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) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 63 and FOLFOX = 73. |
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX |
---|---|---|
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. |
Measure Participants | 283 | 284 |
Median (95% Confidence Interval) [Months] |
5.78
|
6.28
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + FOLFOX, FOLFOX |
---|---|---|
Comments | The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS). | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.6565 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.045 | |
Confidence Interval |
(2-Sided) 95% 0.863 to 1.265 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 45 and FOLFOX = 86. |
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX |
---|---|---|
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. |
Measure Participants | 283 | 284 |
Median (95% Confidence Interval) [Months] |
2.14
|
2.10
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + FOLFOX, FOLFOX |
---|---|---|
Comments | The estimate of hazard ratio (HR) was stratified by region and prior therapy. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.8144 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.981 | |
Confidence Interval |
(2-Sided) 95% 0.808 to 1.190 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX |
---|---|---|
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. |
Measure Participants | 283 | 284 |
Number [Percentage of participants] |
4.6
1.6%
|
5.6
2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + FOLFOX, FOLFOX |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.7044 |
Comments | P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS. | |
Method | Cochran-Mantel-Haenszel | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% 0.4 to 1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX |
---|---|---|
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. |
Measure Participants | 283 | 284 |
Number [Percentage of participants] |
42.8
15.1%
|
36.6
12.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + FOLFOX, FOLFOX |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1463 |
Comments | P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS. | |
Method | Cochran-Mantel-Haenszel | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% 0.9 to 1.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who achieved an objective response of CR or PR. The number of participants censored were Pegilodecakin + FOLFOX = 4 and FOLFOX = 7. |
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX |
---|---|---|
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. |
Measure Participants | 13 | 16 |
Median (95% Confidence Interval) [Months] |
4.99
|
5.17
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + FOLFOX, FOLFOX |
---|---|---|
Comments | The estimate of hazard ratio (HR) was stratified by region and prior therapy. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.9952 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.008 | |
Confidence Interval |
(2-Sided) 95% 0.370 to 2.741 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX |
---|---|---|
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. |
Measure Participants | 283 | 284 |
Number (95% Confidence Interval) [Percentage of participants] |
14.7
5.2%
|
19.1
6.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pegilodecakin + FOLFOX, FOLFOX |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.2298 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -4.4 | |
Confidence Interval |
(2-Sided) 95% -11.6 to 2.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | Baseline Up To 36 Months | |||
---|---|---|---|---|
Adverse Event Reporting Description | All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. | |||
Arm/Group Title | Pegilodecakin + FOLFOX | FOLFOX | ||
Arm/Group Description | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 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 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. | ||
All Cause Mortality |
||||
Pegilodecakin + FOLFOX | FOLFOX | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 217/278 (78.1%) | 188/251 (74.9%) | ||
Serious Adverse Events |
||||
Pegilodecakin + FOLFOX | FOLFOX | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 123/278 (44.2%) | 95/251 (37.8%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 3/278 (1.1%) | 5 | 1/251 (0.4%) | 2 |
Febrile neutropenia | 3/278 (1.1%) | 3 | 1/251 (0.4%) | 1 |
Neutropenia | 2/278 (0.7%) | 3 | 3/251 (1.2%) | 4 |
Thrombocytopenia | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Cardiac disorders | ||||
Acute myocardial infarction | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Angina pectoris | 2/278 (0.7%) | 2 | 0/251 (0%) | 0 |
Atrial fibrillation | 0/278 (0%) | 0 | 2/251 (0.8%) | 2 |
Cardiac arrest | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Cardiac failure acute | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Gastrointestinal disorders | ||||
Abdominal distension | 3/278 (1.1%) | 3 | 0/251 (0%) | 0 |
Abdominal pain | 11/278 (4%) | 14 | 3/251 (1.2%) | 3 |
Abdominal pain lower | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Abdominal pain upper | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Ascites | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Colitis | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Constipation | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Diarrhoea | 2/278 (0.7%) | 3 | 5/251 (2%) | 5 |
Duodenal obstruction | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Duodenal stenosis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Duodenal ulcer haemorrhage | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Dyspepsia | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Gastric haemorrhage | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Gastritis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Gastroduodenal ulcer | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Gastrointestinal haemorrhage | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Gastrointestinal stenosis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Haematemesis | 0/278 (0%) | 0 | 2/251 (0.8%) | 2 |
Ileal perforation | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Intestinal obstruction | 1/278 (0.4%) | 1 | 3/251 (1.2%) | 3 |
Large intestinal obstruction | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Nausea | 3/278 (1.1%) | 4 | 0/251 (0%) | 0 |
Obstruction gastric | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Oesophageal stenosis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Pancreatitis acute | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Small intestinal haemorrhage | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Small intestinal obstruction | 3/278 (1.1%) | 3 | 2/251 (0.8%) | 2 |
Stomatitis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Upper gastrointestinal haemorrhage | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Vomiting | 7/278 (2.5%) | 8 | 5/251 (2%) | 5 |
General disorders | ||||
Asthenia | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Euthanasia | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Fatigue | 1/278 (0.4%) | 2 | 2/251 (0.8%) | 2 |
General physical health deterioration | 3/278 (1.1%) | 3 | 2/251 (0.8%) | 3 |
Generalised oedema | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hyperpyrexia | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Malaise | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Mucosal inflammation | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Multiple organ dysfunction syndrome | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Oedema peripheral | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Pyrexia | 13/278 (4.7%) | 15 | 7/251 (2.8%) | 7 |
Hepatobiliary disorders | ||||
Bile duct obstruction | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Bile duct stenosis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Cholangitis | 6/278 (2.2%) | 8 | 2/251 (0.8%) | 2 |
Cholangitis acute | 2/278 (0.7%) | 3 | 0/251 (0%) | 0 |
Cholecystitis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Cholecystitis acute | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hepatic cirrhosis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hepatic function abnormal | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hepatic pain | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Jaundice cholestatic | 3/278 (1.1%) | 3 | 3/251 (1.2%) | 3 |
Immune system disorders | ||||
Anaphylactic reaction | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Infections and infestations | ||||
Abdominal sepsis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Bacteraemia | 3/278 (1.1%) | 3 | 1/251 (0.4%) | 1 |
Bacterial disease carrier | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Biliary sepsis | 0/278 (0%) | 0 | 2/251 (0.8%) | 2 |
Biliary tract infection | 3/278 (1.1%) | 3 | 1/251 (0.4%) | 4 |
Cellulitis | 1/278 (0.4%) | 2 | 0/251 (0%) | 0 |
Cholangitis infective | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Clostridium difficile colitis | 2/278 (0.7%) | 2 | 0/251 (0%) | 0 |
Device related infection | 4/278 (1.4%) | 5 | 0/251 (0%) | 0 |
Device related sepsis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Diverticulitis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Enterobacter sepsis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Enterocolitis infectious | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Escherichia sepsis | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Gastroenteritis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Gastroenteritis norovirus | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Klebsiella sepsis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Liver abscess | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Lower respiratory tract infection | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Peritonsillar abscess | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Pneumococcal sepsis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Pneumocystis jirovecii pneumonia | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Pneumonia | 7/278 (2.5%) | 8 | 4/251 (1.6%) | 4 |
Pneumonia cryptococcal | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Respiratory tract infection | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Sepsis | 10/278 (3.6%) | 10 | 4/251 (1.6%) | 4 |
Septic shock | 4/278 (1.4%) | 7 | 0/251 (0%) | 0 |
Urinary tract infection | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Urosepsis | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Viral infection | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
Craniocerebral injury | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Fibula fracture | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hip fracture | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Infusion related reaction | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Overdose | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Tibia fracture | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Investigations | ||||
Blood bilirubin increased | 3/278 (1.1%) | 4 | 4/251 (1.6%) | 6 |
Neutrophil count decreased | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Platelet count decreased | 2/278 (0.7%) | 3 | 0/251 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Adult failure to thrive | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Cachexia | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Decreased appetite | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Dehydration | 3/278 (1.1%) | 3 | 1/251 (0.4%) | 1 |
Diabetes mellitus | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Diabetic ketoacidosis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Diabetic metabolic decompensation | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Failure to thrive | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hypercalcaemia | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hyperglycaemia | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Hypokalaemia | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Hyponatraemia | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Lactic acidosis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Back pain | 0/278 (0%) | 0 | 3/251 (1.2%) | 3 |
Bursitis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Flank pain | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Muscular weakness | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Musculoskeletal pain | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Acute myeloid leukaemia | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Tumour pain | 1/278 (0.4%) | 2 | 1/251 (0.4%) | 1 |
Nervous system disorders | ||||
Cerebral ischaemia | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Cerebrovascular accident | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Ischaemic stroke | 1/278 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Lethargy | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Metabolic encephalopathy | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Neuropathy peripheral | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Sciatica | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Transient ischaemic attack | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Product Issues | ||||
Device breakage | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Device failure | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Device occlusion | 3/278 (1.1%) | 3 | 0/251 (0%) | 0 |
Psychiatric disorders | ||||
Completed suicide | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Mental status changes | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Suicide attempt | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Renal and urinary disorders | ||||
Acute kidney injury | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Cystitis haemorrhagic | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Nephrolithiasis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Oliguria | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Renal failure | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Urinary tract obstruction | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Reproductive system and breast disorders | ||||
Prostatic obstruction | 1/144 (0.7%) | 1 | 0/134 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Acute respiratory distress syndrome | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Asthma | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Chronic obstructive pulmonary disease | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Pleural effusion | 2/278 (0.7%) | 2 | 1/251 (0.4%) | 1 |
Pneumonitis | 2/278 (0.7%) | 2 | 0/251 (0%) | 0 |
Pulmonary embolism | 2/278 (0.7%) | 2 | 3/251 (1.2%) | 3 |
Respiratory acidosis | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||
Rash maculo-papular | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Vascular disorders | ||||
Aortic embolus | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Deep vein thrombosis | 1/278 (0.4%) | 2 | 1/251 (0.4%) | 1 |
Embolism | 2/278 (0.7%) | 2 | 2/251 (0.8%) | 2 |
Internal haemorrhage | 1/278 (0.4%) | 1 | 0/251 (0%) | 0 |
Peripheral coldness | 0/278 (0%) | 0 | 1/251 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Pegilodecakin + FOLFOX | FOLFOX | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 271/278 (97.5%) | 240/251 (95.6%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 107/278 (38.5%) | 204 | 38/251 (15.1%) | 56 |
Neutropenia | 58/278 (20.9%) | 118 | 41/251 (16.3%) | 65 |
Thrombocytopenia | 99/278 (35.6%) | 296 | 28/251 (11.2%) | 42 |
Gastrointestinal disorders | ||||
Abdominal distension | 18/278 (6.5%) | 22 | 14/251 (5.6%) | 15 |
Abdominal pain | 82/278 (29.5%) | 114 | 58/251 (23.1%) | 82 |
Abdominal pain upper | 20/278 (7.2%) | 34 | 14/251 (5.6%) | 17 |
Ascites | 28/278 (10.1%) | 35 | 19/251 (7.6%) | 20 |
Constipation | 79/278 (28.4%) | 93 | 59/251 (23.5%) | 70 |
Diarrhoea | 70/278 (25.2%) | 104 | 71/251 (28.3%) | 101 |
Dyspepsia | 21/278 (7.6%) | 23 | 14/251 (5.6%) | 16 |
Flatulence | 14/278 (5%) | 15 | 4/251 (1.6%) | 6 |
Nausea | 126/278 (45.3%) | 217 | 106/251 (42.2%) | 160 |
Stomatitis | 27/278 (9.7%) | 37 | 40/251 (15.9%) | 48 |
Vomiting | 80/278 (28.8%) | 122 | 69/251 (27.5%) | 106 |
General disorders | ||||
Asthenia | 76/278 (27.3%) | 151 | 45/251 (17.9%) | 105 |
Fatigue | 105/278 (37.8%) | 181 | 74/251 (29.5%) | 108 |
Injection site erythema | 18/278 (6.5%) | 18 | 0/251 (0%) | 0 |
Oedema peripheral | 41/278 (14.7%) | 49 | 22/251 (8.8%) | 25 |
Pyrexia | 56/278 (20.1%) | 82 | 36/251 (14.3%) | 51 |
Investigations | ||||
Aspartate aminotransferase increased | 12/278 (4.3%) | 17 | 14/251 (5.6%) | 22 |
Blood alkaline phosphatase increased | 21/278 (7.6%) | 28 | 15/251 (6%) | 20 |
Blood bilirubin increased | 19/278 (6.8%) | 28 | 10/251 (4%) | 12 |
Neutrophil count decreased | 47/278 (16.9%) | 84 | 30/251 (12%) | 51 |
Platelet count decreased | 59/278 (21.2%) | 163 | 26/251 (10.4%) | 51 |
Weight decreased | 14/278 (5%) | 17 | 25/251 (10%) | 34 |
Metabolism and nutrition disorders | ||||
Decreased appetite | 97/278 (34.9%) | 132 | 77/251 (30.7%) | 100 |
Dehydration | 12/278 (4.3%) | 22 | 14/251 (5.6%) | 19 |
Hyperglycaemia | 14/278 (5%) | 20 | 10/251 (4%) | 11 |
Hypoalbuminaemia | 20/278 (7.2%) | 28 | 10/251 (4%) | 11 |
Hypokalaemia | 21/278 (7.6%) | 37 | 29/251 (11.6%) | 39 |
Hyponatraemia | 11/278 (4%) | 15 | 16/251 (6.4%) | 21 |
Musculoskeletal and connective tissue disorders | ||||
Back pain | 37/278 (13.3%) | 44 | 32/251 (12.7%) | 39 |
Nervous system disorders | ||||
Dizziness | 19/278 (6.8%) | 23 | 8/251 (3.2%) | 9 |
Dysgeusia | 19/278 (6.8%) | 22 | 9/251 (3.6%) | 11 |
Headache | 18/278 (6.5%) | 24 | 17/251 (6.8%) | 20 |
Neuropathy peripheral | 40/278 (14.4%) | 50 | 38/251 (15.1%) | 62 |
Neurotoxicity | 13/278 (4.7%) | 25 | 15/251 (6%) | 30 |
Paraesthesia | 24/278 (8.6%) | 34 | 17/251 (6.8%) | 44 |
Peripheral sensory neuropathy | 31/278 (11.2%) | 48 | 29/251 (11.6%) | 35 |
Polyneuropathy | 9/278 (3.2%) | 13 | 14/251 (5.6%) | 25 |
Psychiatric disorders | ||||
Insomnia | 14/278 (5%) | 14 | 13/251 (5.2%) | 13 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 17/278 (6.1%) | 22 | 19/251 (7.6%) | 22 |
Dyspnoea | 30/278 (10.8%) | 41 | 15/251 (6%) | 17 |
Skin and subcutaneous tissue disorders | ||||
Pruritus | 15/278 (5.4%) | 24 | 8/251 (3.2%) | 11 |
Rash | 23/278 (8.3%) | 34 | 9/251 (3.6%) | 10 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
ClinicalTrials.gov@lilly.com |
- 17158
- J1L-AM-JZGB
- AM0010-301
- 2016-003858-33