Trial · NCT05440786
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
NCT05440786, Phase 2, Active not recruiting, Eli Lilly and Company; results first posted 2026-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma. Trials, record NCT05440786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05440786
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
- NCT number
- NCT05440786
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Sarcoma, Ewing, Neoplasm Metastasis
- Interventions
- Abemaciclib, Irinotecan, Temozolomide
- First posted
- 2022-07-01
- Last updated
- 2026-10-20
- Other registries' IDs
- eudract:2021-004734-11
- Results first posted
- 2026-03-12
- Limitations and caveats
The Bayesian models for PFS by BIRC and PFS by Investigator assume an exponential distribution for the PFS times, which is more restrictive than the distributional assumptions made by the frequentist Cox proportional hazards model.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) | PFS was defined as the time from randomization until the first occurrence of documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause in absence of progressive disease, whichever came first. Progressive disease (PD) was defined as at least 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 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval. |
| Primary | PFS Assessed by BIRC by Frequentist Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least 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. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis. |
| Secondary | PFS Assessed by Investigator by Bayesian Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of 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. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval. |
| Secondary | PFS Assessed by Investigator by Frequentist Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of 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. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis. |
| Secondary | Overall Survival (OS) | From Date of Randomization until Death Due to Any Cause (Up to 26.37 months) | OS was defined as the time from date of randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) Assessed by BIRC | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) | ORR was defined as the number of participants who achieved the best overall response of complete response (CR) or partial response (PR) as per 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 longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. |
| Secondary | ORR: Percentage of Participants Who Achieved a CR or PR Assessed by Investigator | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months) | ORR was defined as the number of participants who achieved the best overall response of CR or PR as per 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 longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. |
| Secondary | Duration of Response (DoR) Assessed by BIRC | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 10.7 Months) | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was 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 with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan. |
| Secondary | DoR Assessed by Investigator | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 12.7 Months) | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed, per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan. |
| Secondary | Percentage of Participants With a Best Overall Response of CR, PR, Stable Disease (SD) or Non-CR/Non-PD: Disease Control Rate (DCR) Assessed by BIRC | From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) | Disease control rate (DCR) was the percentage of participants with a best overall response of CR, PR, SD or Non-CR/Non-PD as defined by RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was 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. Non-CR/Non-PD was defined as persistence of one or more non-target lesions and/or maintained tumor marker levels, but without sufficient progression to be considered PD and without complete disappearance to be CR. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =8, Irinotecan +Temozolomide = 3. | Months | MEAN |
| PRIMARY | PFS Assessed by BIRC by Frequentist Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =8, Irinotecan +Temozolomide = 3. | Months | MEDIAN |
| SECONDARY | PFS Assessed by Investigator by Bayesian Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =6, Irinotecan +Temozolomide = 3. | Months | MEAN |
| SECONDARY | PFS Assessed by Investigator by Frequentist Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =6, Irinotecan +Temozolomide = 3. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From Date of Randomization until Death Due to Any Cause (Up to 26.37 months) | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide = 15, Irinotecan +Temozolomide = 7. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) Assessed by BIRC | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) | All randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | ORR: Percentage of Participants Who Achieved a CR or PR Assessed by Investigator | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months) | All randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DoR) Assessed by BIRC | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 10.7 Months) | All randomized participants who received at least one dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =1, Irinotecan +Temozolomide = 3. | Months | MEDIAN |
| SECONDARY | DoR Assessed by Investigator | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 12.7 Months) | All randomized participants who received at least one dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =2, Irinotecan +Temozolomide = 1. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With a Best Overall Response of CR, PR, Stable Disease (SD) or Non-CR/Non-PD: Disease Control Rate (DCR) Assessed by BIRC | From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) | All randomized participants. | Percentage of Participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis | Abemaciclib + Irinotecan +Temozolomide | NA | 80% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis | Irinotecan +Temozolomide | NA | 80% Confidence Interval NA to NA | Months | |
| PFS Assessed by BIRC by Frequentist Analysis | Abemaciclib + Irinotecan +Temozolomide | 2.79 | 95% Confidence Interval 1.74 to 13.32 | Months | |
| PFS Assessed by BIRC by Frequentist Analysis | Irinotecan +Temozolomide | 2.89 | 95% Confidence Interval 1.25 to 5.13 | Months | |
| PFS Assessed by Investigator by Bayesian Analysis | Abemaciclib + Irinotecan +Temozolomide | NA | 80% Confidence Interval NA to NA | Months | |
| PFS Assessed by Investigator by Bayesian Analysis | Irinotecan +Temozolomide | NA | 80% Confidence Interval NA to NA | Months | |
| PFS Assessed by Investigator by Frequentist Analysis | Abemaciclib + Irinotecan +Temozolomide | 2.93 | 95% Confidence Interval 1.74 to 10.59 | Months | |
| PFS Assessed by Investigator by Frequentist Analysis | Irinotecan +Temozolomide | 3.81 | 95% Confidence Interval 1.41 to 6.94 | Months | |
| Overall Survival (OS) | Abemaciclib + Irinotecan +Temozolomide | 21.21 | 95% Confidence Interval 9.17 to NA | Months | |
| Overall Survival (OS) | Irinotecan +Temozolomide | 6.94 | 95% Confidence Interval 5.13 to NA | Months |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abemaciclib + Irinotecan +Temozolomide | 30 | |
| Overall Study | STARTED | Irinotecan +Temozolomide | 16 | |
| Overall Study | Received at Least One Dose of Study Drug | Abemaciclib + Irinotecan +Temozolomide | 30 | |
| Overall Study | Received at Least One Dose of Study Drug | Irinotecan +Temozolomide | 15 | |
| Overall Study | COMPLETED | Abemaciclib + Irinotecan +Temozolomide | 15 | |
| Overall Study | COMPLETED | Irinotecan +Temozolomide | 8 | |
| Overall Study | NOT COMPLETED | Abemaciclib + Irinotecan +Temozolomide | 15 | |
| Overall Study | NOT COMPLETED | Irinotecan +Temozolomide | 8 |
Source ClinicalTrials.gov
Adverse events408
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 | Abemaciclib + Irinotecan +Temozolomide | 19 | 30 | 26 |
| other | Anaemia | Blood and lymphatic system disorders | Irinotecan +Temozolomide | 6 | 15 | 8 |
| other | Eosinophilia | Blood and lymphatic system disorders | Abemaciclib + Irinotecan +Temozolomide | 1 | 30 | 2 |
| other | Eosinophilia | Blood and lymphatic system disorders | Irinotecan +Temozolomide | 1 | 15 | 5 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Abemaciclib + Irinotecan +Temozolomide | 1 | 30 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Irinotecan +Temozolomide | 0 | 15 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Abemaciclib + Irinotecan +Temozolomide | 3 | 30 | 19 |
| other | Leukopenia | Blood and lymphatic system disorders | Irinotecan +Temozolomide | 2 | 15 | 16 |
| other | Lymphopenia | Blood and lymphatic system disorders | Abemaciclib + Irinotecan +Temozolomide | 0 | 30 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Irinotecan +Temozolomide | 2 | 15 | 8 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abemaciclib + Irinotecan +Temozolomide | 15 | 30 |
| Total, all-cause mortality | Irinotecan +Temozolomide | 8 | 16 |
| Total, other adverse events | Abemaciclib + Irinotecan +Temozolomide | 30 | 30 |
| Total, other adverse events | Irinotecan +Temozolomide | 15 | 15 |
| Total, serious adverse events | Abemaciclib + Irinotecan +Temozolomide | 12 | 30 |
| Total, serious adverse events | Irinotecan +Temozolomide | 5 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Abemaciclib + Irinotecan +Temozolomide vs Irinotecan +Temozolomide: deaths from any cause | Trial comparisons |
| Abemaciclib + Irinotecan +Temozolomide vs Irinotecan +Temozolomide: 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/NCT05440786
GET https://conductscience.org/api/trials/v1/NCT05440786/results?page=2