Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    am0010 | Phase 3
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923921
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Biological: Pegilodecakin
Drug: FOLFOX
Enrollment 567
Recruitment Details  
Pre-assignment Details 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
Hide 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
Reason Not Completed
Sponsor Decision             39             38
Lost to Follow-up             1             0
Withdrawal by Subject             6             13
Unknown, Not Collected             7             6
Arm/Group Title Pegilodecakin + FOLFOX FOLFOX Total
Hide 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 Number of Baseline Participants 283 284 567
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 284 participants 567 participants
63.8  (9.0) 64.1  (9.9) 64.0  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 284 participants 567 participants
Female 135 132 267
Male 148 152 300
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 284 participants 567 participants
Hispanic or Latino 9 6 15
Not Hispanic or Latino 263 265 528
Unknown or Not Reported 11 13 24
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 284 participants 567 participants
American Indian or Alaska Native 1 0 1
Asian 59 55 114
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 8 8 16
White 207 213 420
More than one race 0 0 0
Unknown or Not Reported 8 7 15
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 284 participants 567 participants
United States 93 89 182
United Kingdom 5 4 9
Spain 42 31 73
Canada 2 7 9
South Korea 48 41 89
Austria 3 10 13
Belgium 17 19 36
Taiwan 5 10 15
Poland 8 5 13
Italy 28 39 67
France 9 2 11
Australia 14 16 30
Germany 9 11 20
1.Primary Outcome
Title Overall Survival
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 63 and FOLFOX = 73.
Arm/Group Title Pegilodecakin + FOLFOX FOLFOX
Hide 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.
Overall Number of Participants Analyzed 283 284
Median (95% Confidence Interval)
Unit of Measure: Months
5.78
(5.45 to 6.64)
6.28
(5.62 to 7.39)
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.6565
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.045
Confidence Interval (2-Sided) 95%
0.863 to 1.265
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression Free Survival
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 45 and FOLFOX = 86.
Arm/Group Title Pegilodecakin + FOLFOX FOLFOX
Hide 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.
Overall Number of Participants Analyzed 283 284
Median (95% Confidence Interval)
Unit of Measure: Months
2.14
(1.94 to 3.38)
2.10
(1.94 to 3.25)
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.8144
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.981
Confidence Interval (2-Sided) 95%
0.808 to 1.190
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pegilodecakin + FOLFOX FOLFOX
Hide 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.
Overall Number of Participants Analyzed 283 284
Measure Type: Number
Unit of Measure: Percentage of participants
4.6 5.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.4 to 1.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pegilodecakin + FOLFOX FOLFOX
Hide 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.
Overall Number of Participants Analyzed 283 284
Measure Type: Number
Unit of Measure: Percentage of participants
42.8 36.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.9 to 1.8
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Duration of Response (DOR)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 13 16
Median (95% Confidence Interval)
Unit of Measure: Months
4.99
(3.45 to 7.06)
5.17
(3.75 to 5.72)
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.9952
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.008
Confidence Interval (2-Sided) 95%
0.370 to 2.741
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Alive at 1 Year (12-Month Survival Rate)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pegilodecakin + FOLFOX FOLFOX
Hide 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.
Overall Number of Participants Analyzed 283 284
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.7
(10.2 to 19.9)
19.1
(14.1 to 24.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegilodecakin + FOLFOX, FOLFOX
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2298
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-11.6 to 2.8
Estimation Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   217/278 (78.06%)      188/251 (74.90%)    
Hide Serious Adverse Events
Pegilodecakin + FOLFOX FOLFOX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   123/278 (44.24%)      95/251 (37.85%)    
Blood and lymphatic system disorders     
Anaemia  1  3/278 (1.08%)  5 1/251 (0.40%)  2
Febrile neutropenia  1  3/278 (1.08%)  3 1/251 (0.40%)  1
Neutropenia  1  2/278 (0.72%)  3 3/251 (1.20%)  4
Thrombocytopenia  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Angina pectoris  1  2/278 (0.72%)  2 0/251 (0.00%)  0
Atrial fibrillation  1  0/278 (0.00%)  0 2/251 (0.80%)  2
Cardiac arrest  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Cardiac failure acute  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Gastrointestinal disorders     
Abdominal distension  1  3/278 (1.08%)  3 0/251 (0.00%)  0
Abdominal pain  1  11/278 (3.96%)  14 3/251 (1.20%)  3
Abdominal pain lower  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Abdominal pain upper  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Ascites  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Colitis  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Constipation  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Diarrhoea  1  2/278 (0.72%)  3 5/251 (1.99%)  5
Duodenal obstruction  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Duodenal stenosis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Duodenal ulcer haemorrhage  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Dyspepsia  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Gastric haemorrhage  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Gastritis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Gastroduodenal ulcer  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Gastrointestinal haemorrhage  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Gastrointestinal stenosis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Haematemesis  1  0/278 (0.00%)  0 2/251 (0.80%)  2
Ileal perforation  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Intestinal obstruction  1  1/278 (0.36%)  1 3/251 (1.20%)  3
Large intestinal obstruction  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Nausea  1  3/278 (1.08%)  4 0/251 (0.00%)  0
Obstruction gastric  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Oesophageal stenosis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Pancreatitis acute  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Small intestinal haemorrhage  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Small intestinal obstruction  1  3/278 (1.08%)  3 2/251 (0.80%)  2
Stomatitis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Vomiting  1  7/278 (2.52%)  8 5/251 (1.99%)  5
General disorders     
Asthenia  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Euthanasia  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Fatigue  1  1/278 (0.36%)  2 2/251 (0.80%)  2
General physical health deterioration  1  3/278 (1.08%)  3 2/251 (0.80%)  3
Generalised oedema  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hyperpyrexia  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Malaise  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Mucosal inflammation  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Multiple organ dysfunction syndrome  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Oedema peripheral  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Pyrexia  1  13/278 (4.68%)  15 7/251 (2.79%)  7
Hepatobiliary disorders     
Bile duct obstruction  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Bile duct stenosis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Cholangitis  1  6/278 (2.16%)  8 2/251 (0.80%)  2
Cholangitis acute  1  2/278 (0.72%)  3 0/251 (0.00%)  0
Cholecystitis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Cholecystitis acute  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hepatic cirrhosis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hepatic function abnormal  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hepatic pain  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Jaundice cholestatic  1  3/278 (1.08%)  3 3/251 (1.20%)  3
Immune system disorders     
Anaphylactic reaction  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Infections and infestations     
Abdominal sepsis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Bacteraemia  1  3/278 (1.08%)  3 1/251 (0.40%)  1
Bacterial disease carrier  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Biliary sepsis  1  0/278 (0.00%)  0 2/251 (0.80%)  2
Biliary tract infection  1  3/278 (1.08%)  3 1/251 (0.40%)  4
Cellulitis  1  1/278 (0.36%)  2 0/251 (0.00%)  0
Cholangitis infective  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Clostridium difficile colitis  1  2/278 (0.72%)  2 0/251 (0.00%)  0
Device related infection  1  4/278 (1.44%)  5 0/251 (0.00%)  0
Device related sepsis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Diverticulitis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Enterobacter sepsis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Enterocolitis infectious  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Escherichia sepsis  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Gastroenteritis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Gastroenteritis norovirus  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Klebsiella sepsis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Liver abscess  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Lower respiratory tract infection  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Peritonsillar abscess  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Pneumococcal sepsis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Pneumocystis jirovecii pneumonia  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Pneumonia  1  7/278 (2.52%)  8 4/251 (1.59%)  4
Pneumonia cryptococcal  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Respiratory tract infection  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Sepsis  1  10/278 (3.60%)  10 4/251 (1.59%)  4
Septic shock  1  4/278 (1.44%)  7 0/251 (0.00%)  0
Urinary tract infection  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Urosepsis  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Viral infection  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Injury, poisoning and procedural complications     
Craniocerebral injury  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Fibula fracture  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hip fracture  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Infusion related reaction  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Overdose  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Tibia fracture  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Investigations     
Blood bilirubin increased  1  3/278 (1.08%)  4 4/251 (1.59%)  6
Neutrophil count decreased  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Platelet count decreased  1  2/278 (0.72%)  3 0/251 (0.00%)  0
Metabolism and nutrition disorders     
Adult failure to thrive  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Cachexia  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Decreased appetite  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Dehydration  1  3/278 (1.08%)  3 1/251 (0.40%)  1
Diabetes mellitus  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Diabetic ketoacidosis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Diabetic metabolic decompensation  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Failure to thrive  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hypercalcaemia  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hyperglycaemia  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Hypokalaemia  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Hyponatraemia  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Lactic acidosis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  0/278 (0.00%)  0 3/251 (1.20%)  3
Bursitis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Flank pain  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Muscular weakness  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Musculoskeletal pain  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Tumour pain  1  1/278 (0.36%)  2 1/251 (0.40%)  1
Nervous system disorders     
Cerebral ischaemia  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Cerebrovascular accident  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Ischaemic stroke  1  1/278 (0.36%)  1 1/251 (0.40%)  1
Lethargy  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Metabolic encephalopathy  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Neuropathy peripheral  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Sciatica  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Transient ischaemic attack  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Product Issues     
Device breakage  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Device failure  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Device occlusion  1  3/278 (1.08%)  3 0/251 (0.00%)  0
Psychiatric disorders     
Completed suicide  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Mental status changes  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Suicide attempt  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Cystitis haemorrhagic  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Nephrolithiasis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Oliguria  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Renal failure  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Urinary tract obstruction  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Reproductive system and breast disorders     
Prostatic obstruction  1  1/144 (0.69%)  1 0/134 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Asthma  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Pleural effusion  1  2/278 (0.72%)  2 1/251 (0.40%)  1
Pneumonitis  1  2/278 (0.72%)  2 0/251 (0.00%)  0
Pulmonary embolism  1  2/278 (0.72%)  2 3/251 (1.20%)  3
Respiratory acidosis  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Vascular disorders     
Aortic embolus  1  0/278 (0.00%)  0 1/251 (0.40%)  1
Deep vein thrombosis  1  1/278 (0.36%)  2 1/251 (0.40%)  1
Embolism  1  2/278 (0.72%)  2 2/251 (0.80%)  2
Internal haemorrhage  1  1/278 (0.36%)  1 0/251 (0.00%)  0
Peripheral coldness  1  0/278 (0.00%)  0 1/251 (0.40%)  1
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegilodecakin + FOLFOX FOLFOX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   271/278 (97.48%)      240/251 (95.62%)    
Blood and lymphatic system disorders     
Anaemia  1  107/278 (38.49%)  204 38/251 (15.14%)  56
Neutropenia  1  58/278 (20.86%)  118 41/251 (16.33%)  65
Thrombocytopenia  1  99/278 (35.61%)  296 28/251 (11.16%)  42
Gastrointestinal disorders     
Abdominal distension  1  18/278 (6.47%)  22 14/251 (5.58%)  15
Abdominal pain  1  82/278 (29.50%)  114 58/251 (23.11%)  82
Abdominal pain upper  1  20/278 (7.19%)  34 14/251 (5.58%)  17
Ascites  1  28/278 (10.07%)  35 19/251 (7.57%)  20
Constipation  1  79/278 (28.42%)  93 59/251 (23.51%)  70
Diarrhoea  1  70/278 (25.18%)  104 71/251 (28.29%)  101
Dyspepsia  1  21/278 (7.55%)  23 14/251 (5.58%)  16
Flatulence  1  14/278 (5.04%)  15 4/251 (1.59%)  6
Nausea  1  126/278 (45.32%)  217 106/251 (42.23%)  160
Stomatitis  1  27/278 (9.71%)  37 40/251 (15.94%)  48
Vomiting  1  80/278 (28.78%)  122 69/251 (27.49%)  106
General disorders     
Asthenia  1  76/278 (27.34%)  151 45/251 (17.93%)  105
Fatigue  1  105/278 (37.77%)  181 74/251 (29.48%)  108
Injection site erythema  1  18/278 (6.47%)  18 0/251 (0.00%)  0
Oedema peripheral  1  41/278 (14.75%)  49 22/251 (8.76%)  25
Pyrexia  1  56/278 (20.14%)  82 36/251 (14.34%)  51
Investigations     
Aspartate aminotransferase increased  1  12/278 (4.32%)  17 14/251 (5.58%)  22
Blood alkaline phosphatase increased  1  21/278 (7.55%)  28 15/251 (5.98%)  20
Blood bilirubin increased  1  19/278 (6.83%)  28 10/251 (3.98%)  12
Neutrophil count decreased  1  47/278 (16.91%)  84 30/251 (11.95%)  51
Platelet count decreased  1  59/278 (21.22%)  163 26/251 (10.36%)  51
Weight decreased  1  14/278 (5.04%)  17 25/251 (9.96%)  34
Metabolism and nutrition disorders     
Decreased appetite  1  97/278 (34.89%)  132 77/251 (30.68%)  100
Dehydration  1  12/278 (4.32%)  22 14/251 (5.58%)  19
Hyperglycaemia  1  14/278 (5.04%)  20 10/251 (3.98%)  11
Hypoalbuminaemia  1  20/278 (7.19%)  28 10/251 (3.98%)  11
Hypokalaemia  1  21/278 (7.55%)  37 29/251 (11.55%)  39
Hyponatraemia  1  11/278 (3.96%)  15 16/251 (6.37%)  21
Musculoskeletal and connective tissue disorders     
Back pain  1  37/278 (13.31%)  44 32/251 (12.75%)  39
Nervous system disorders     
Dizziness  1  19/278 (6.83%)  23 8/251 (3.19%)  9
Dysgeusia  1  19/278 (6.83%)  22 9/251 (3.59%)  11
Headache  1  18/278 (6.47%)  24 17/251 (6.77%)  20
Neuropathy peripheral  1  40/278 (14.39%)  50 38/251 (15.14%)  62
Neurotoxicity  1  13/278 (4.68%)  25 15/251 (5.98%)  30
Paraesthesia  1  24/278 (8.63%)  34 17/251 (6.77%)  44
Peripheral sensory neuropathy  1  31/278 (11.15%)  48 29/251 (11.55%)  35
Polyneuropathy  1  9/278 (3.24%)  13 14/251 (5.58%)  25
Psychiatric disorders     
Insomnia  1  14/278 (5.04%)  14 13/251 (5.18%)  13
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/278 (6.12%)  22 19/251 (7.57%)  22
Dyspnoea  1  30/278 (10.79%)  41 15/251 (5.98%)  17
Skin and subcutaneous tissue disorders     
Pruritus  1  15/278 (5.40%)  24 8/251 (3.19%)  11
Rash  1  23/278 (8.27%)  34 9/251 (3.59%)  10
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02923921    
Other Study ID Numbers: 17158
J1L-AM-JZGB ( Other Identifier: Eli Lilly and Company )
AM0010-301 ( Other Identifier: ARMO BioSciences )
2016-003858-33 ( EudraCT Number )
First Submitted: September 30, 2016
First Posted: October 5, 2016
Results First Submitted: August 14, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020