Trial · NCT02923921
Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
NCT02923921, Phase 3, Completed, Eli Lilly and Company; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer. Trials, record NCT02923921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02923921
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
- NCT number
- NCT02923921
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 567 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Pancreatic Cancer
- Interventions
- Pegilodecakin, FOLFOX
- First posted
- 2016-10-05
- Last updated
- 2020-10-19
- Other registries' IDs
- eudract:2016-003858-33
- Results first posted
- 2020-10-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Randomization to date of death from any cause (Up To 30 Months) | All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 63 and FOLFOX = 73. | Months | MEDIAN |
| SECONDARY | Progression Free Survival | Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months) | All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 45 and FOLFOX = 86. | Months | MEDIAN |
| SECONDARY | 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) | All randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | 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) | All randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months) | All randomized participants who achieved an objective response of CR or PR. The number of participants censored were Pegilodecakin + FOLFOX = 4 and FOLFOX = 7. | Months | MEDIAN |
| SECONDARY | 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 | All randomized participants. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Pegilodecakin + FOLFOX | 5.78 | 95% Confidence Interval 5.45 to 6.64 | Months | |
| Overall Survival | FOLFOX | 6.28 | 95% Confidence Interval 5.62 to 7.39 | Months | |
| Progression Free Survival | Pegilodecakin + FOLFOX | 2.14 | 95% Confidence Interval 1.94 to 3.38 | Months | |
| Progression Free Survival | FOLFOX | 2.10 | 95% Confidence Interval 1.94 to 3.25 | Months | |
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator | Pegilodecakin + FOLFOX | 4.6 | Percentage of participants | ||
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator | FOLFOX | 5.6 | Percentage of participants | ||
| Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) | Pegilodecakin + FOLFOX | 42.8 | Percentage of participants | ||
| Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) | FOLFOX | 36.6 | Percentage of participants | ||
| Duration of Response (DOR) | Pegilodecakin + FOLFOX | 4.99 | 95% Confidence Interval 3.45 to 7.06 | Months | |
| Duration of Response (DOR) | FOLFOX | 5.17 | 95% Confidence Interval 3.75 to 5.72 | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegilodecakin + FOLFOX | 283 | |
| Overall Study | STARTED | FOLFOX | 284 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Pegilodecakin + FOLFOX | 278 | |
| Overall Study | Received at Least 1 Dose of Study Drug | FOLFOX | 251 | |
| Overall Study | Safety Population | Pegilodecakin + FOLFOX | 278 | |
| Overall Study | Safety Population | FOLFOX | 251 | |
| Overall Study | COMPLETED | Pegilodecakin + FOLFOX | 230 | |
| Overall Study | COMPLETED | FOLFOX | 227 | |
| Overall Study | NOT COMPLETED | Pegilodecakin + FOLFOX | 53 | |
| Overall Study | NOT COMPLETED | FOLFOX | 57 |
Source ClinicalTrials.gov
Adverse events398
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pegilodecakin + FOLFOX | 107 | 278 | 204 |
| other | Anaemia | Blood and lymphatic system disorders | FOLFOX | 38 | 251 | 56 |
| other | Neutropenia | Blood and lymphatic system disorders | Pegilodecakin + FOLFOX | 58 | 278 | 118 |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFOX | 41 | 251 | 65 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pegilodecakin + FOLFOX | 99 | 278 | 296 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | FOLFOX | 28 | 251 | 42 |
| other | Abdominal distension | Gastrointestinal disorders | Pegilodecakin + FOLFOX | 18 | 278 | 22 |
| other | Abdominal distension | Gastrointestinal disorders | FOLFOX | 14 | 251 | 15 |
| other | Abdominal pain | Gastrointestinal disorders | Pegilodecakin + FOLFOX | 82 | 278 | 114 |
| other | Abdominal pain | Gastrointestinal disorders | FOLFOX | 58 | 251 | 82 |
1 to 10 of 398Source ClinicalTrials.gov
See all 398 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegilodecakin + FOLFOX | 217 | 278 |
| Total, all-cause mortality | FOLFOX | 188 | 251 |
| Total, other adverse events | Pegilodecakin + FOLFOX | 271 | 278 |
| Total, other adverse events | FOLFOX | 240 | 251 |
| Total, serious adverse events | Pegilodecakin + FOLFOX | 123 | 278 |
| Total, serious adverse events | FOLFOX | 95 | 251 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33555926 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pegilodecakin + FOLFOX vs FOLFOX: deaths from any cause | Trial comparisons |
| Pegilodecakin + FOLFOX vs FOLFOX: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02923921
GET https://conductscience.org/api/trials/v1/NCT02923921/events?page=2