Trial · NCT04145349
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor
NCT04145349, Phase 1, Phase 2, Completed, Eli Lilly and Company; results first posted 2025-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor. Trials, record NCT04145349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04145349
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor
- NCT number
- NCT04145349
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Desmoplastic Small Round Cell Tumor
- Interventions
- Ramucirumab, Cyclophosphamide, Vinorelbine
- First posted
- 2019-10-30
- Last updated
- 2026-08-07
- Other registries' IDs
- eudract:2018-004242-42
- Results first posted
- 2025-07-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months) | PFS was defined as the time from randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause in the absence of disease progression. Progressive disease (PD) was defined as 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.Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). The posterior median and 98% credible interval were estimated using Bayesian analysis. Data are presented as the posterior median with 98% credible interval. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | Randomization until measured progressive disease (Up To 23 Months) | * The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma. * CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to \<10 mm. Tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference. |
| Secondary | Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 23 Months) | DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence .Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). |
| Secondary | Complete Response (CR) : Percentage of Participants Who Achieved a CR | Randomization until measured progressive disease (Up To 23 Months) | CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to \<10 mm.Tumor marker results were required to have normalized. |
| Secondary | Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) | End of ramucirumab infusion on Day 1 of Cycle 1 | Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics. |
| Secondary | PK: Minimum Serum Concentration of Ramucirumab (Cmin) | Prior to ramucirumab infusion on - Day 15 of Cycle 1 and Day 1 of Cycles 2, 4, 7, and 10 | Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics. |
| Secondary | Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA) | Baseline Up to 23 months | A TE-ADA evaluable participant is considered TE-ADA positive if they have at least one post-baseline ADA titer that is a 4-fold or greater increase from their baseline titer (treatment-boosted); alternatively, if the baseline ADA result is Not Present, the participant is considered TE-ADA positive if there is at least one post-baseline ADA result that is Present with a titer greater than or equal to 1:20 (treatment-induced). |
Source ClinicalTrials.gov
Outcomes7
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) | Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months) | All randomized participants who received at least one dose of study drug (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 4, Cyclophosphamide + Vinorelbine = 2. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | Randomization until measured progressive disease (Up To 23 Months) | All randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 23 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 Ramucirumab + Cyclophosphamide + Vinorelbine = 0, Cyclophosphamide + Vinorelbine = 1. | Months | MEDIAN |
| SECONDARY | Complete Response (CR) : Percentage of Participants Who Achieved a CR | Randomization until measured progressive disease (Up To 23 Months) | All randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) | End of ramucirumab infusion on Day 1 of Cycle 1 | All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Minimum Serum Concentration of Ramucirumab (Cmin) | Prior to ramucirumab infusion on - Day 15 of Cycle 1 and Day 1 of Cycles 2, 4, 7, and 10 | All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome. Number analyzed refers to participants evaluable at specified time points. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA) | Baseline Up to 23 months | All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
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) | Ramucirumab + Cyclophosphamide + Vinorelbine | NA | 98% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Cyclophosphamide + Vinorelbine | NA | 98% Confidence Interval NA to NA | Months | |
| Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | Ramucirumab + Cyclophosphamide + Vinorelbine | 10 | 80% Confidence Interval 2.7 to 24.5 | Percentage of participants | |
| Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | Cyclophosphamide + Vinorelbine | 10 | 80% Confidence Interval 1.1 to 33.7 | Percentage of participants | |
| Duration of Response (DoR) | Ramucirumab + Cyclophosphamide + Vinorelbine | 9.55 | 80% Confidence Interval 4.89 to NA | Months | |
| Duration of Response (DoR) | Cyclophosphamide + Vinorelbine | NA | 80% Confidence Interval NA to NA | Months | |
| Complete Response (CR) : Percentage of Participants Who Achieved a CR | Ramucirumab + Cyclophosphamide + Vinorelbine | 5.0 | 80% Confidence Interval 0.5 to 18.1 | Percentage of participants | |
| Complete Response (CR) : Percentage of Participants Who Achieved a CR | Cyclophosphamide + Vinorelbine | 0 | 80% Confidence Interval 0.0 to 20.6 | Percentage of participants | |
| Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) | Ramucirumab + Cyclophosphamide + Vinorelbine | 238 | Geometric Coefficient of Variation 35 | microgram per milliliter (µg/mL) | |
| PK: Minimum Serum Concentration of Ramucirumab (Cmin) | Ramucirumab + Cyclophosphamide + Vinorelbine | Day 15 of Cycle 1 | 41.6 | Geometric Coefficient of Variation 57 | microgram per milliliter (µg/mL) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramucirumab + Cyclophosphamide + Vinorelbine | 20 | |
| Overall Study | STARTED | Cyclophosphamide + Vinorelbine | 10 | |
| Overall Study | Received at Least One Dose of Study Drug | Ramucirumab + Cyclophosphamide + Vinorelbine | 20 | |
| Overall Study | Received at Least One Dose of Study Drug | Cyclophosphamide + Vinorelbine | 10 | |
| Overall Study | COMPLETED | Ramucirumab + Cyclophosphamide + Vinorelbine | 17 | |
| Overall Study | COMPLETED | Cyclophosphamide + Vinorelbine | 8 | |
| Overall Study | NOT COMPLETED | Ramucirumab + Cyclophosphamide + Vinorelbine | 3 | |
| Overall Study | NOT COMPLETED | Cyclophosphamide + Vinorelbine | 2 |
Source ClinicalTrials.gov
Adverse events302
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 | Ramucirumab + Cyclophosphamide + Vinorelbine | 8 | 20 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Cyclophosphamide + Vinorelbine | 2 | 10 | 13 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Ramucirumab + Cyclophosphamide + Vinorelbine | 1 | 20 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cyclophosphamide + Vinorelbine | 0 | 10 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Ramucirumab + Cyclophosphamide + Vinorelbine | 2 | 20 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Cyclophosphamide + Vinorelbine | 0 | 10 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Ramucirumab + Cyclophosphamide + Vinorelbine | 1 | 20 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cyclophosphamide + Vinorelbine | 0 | 10 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Ramucirumab + Cyclophosphamide + Vinorelbine | 11 | 20 | 28 |
| other | Neutropenia | Blood and lymphatic system disorders | Cyclophosphamide + Vinorelbine | 1 | 10 | 3 |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab + Cyclophosphamide + Vinorelbine | 12 | 20 |
| Total, all-cause mortality | Cyclophosphamide + Vinorelbine | 7 | 10 |
| Total, other adverse events | Ramucirumab + Cyclophosphamide + Vinorelbine | 20 | 20 |
| Total, other adverse events | Cyclophosphamide + Vinorelbine | 10 | 10 |
| Total, serious adverse events | Ramucirumab + Cyclophosphamide + Vinorelbine | 6 | 20 |
| Total, serious adverse events | Cyclophosphamide + Vinorelbine | 3 | 10 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine vs Cyclophosphamide + Vinorelbine: Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA) | Trial comparisons |
| Ramucirumab + Cyclophosphamide + Vinorelbine vs Cyclophosphamide + Vinorelbine: deaths from any cause | Trial comparisons |
| Ramucirumab + Cyclophosphamide + Vinorelbine vs Cyclophosphamide + Vinorelbine: 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/NCT04145349
GET https://conductscience.org/api/trials/v1/NCT04145349/events?page=2