Trial · NCT03899805
A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas
NCT03899805, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2025-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas. Trials, record NCT03899805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03899805
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas
- NCT number
- NCT03899805
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Sarcoma, Liposarcoma, Leiomyosarcoma, Undifferentiated Pleomorphic Sarcoma
- Interventions
- Eribulin, Pembrolizumab
- First posted
- 2019-04-02
- Last updated
- 2025-08-28
- Results first posted
- 2025-08-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 12-week Progression Free Survival (PFS) | 12 weeks | 12-week PFS was defined as the percent probability estimate at 12 weeks based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
| Secondary | Median Overall Survival (OS) | Up to 2 years | Overall Survival (OS) based on Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive. |
| Secondary | Objective Response Rate(ORR) | Up to 2 years | ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Clinical Benefit Response Rate (CBR) | Up to 2 years | CBR is defined as the proportion of participants who reached stable disease, partical response and complete resposne during treatment based on RECIST 1.1 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 12-week Progression Free Survival (PFS) | 12 weeks | percentage of participants | NUMBER | |
| SECONDARY | Median Overall Survival (OS) | Up to 2 years | Weeks | MEDIAN | |
| SECONDARY | Objective Response Rate(ORR) | Up to 2 years | proportion of participants | NUMBER | |
| SECONDARY | Clinical Benefit Response Rate (CBR) | Up to 2 years | proportion 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 |
|---|---|---|---|---|---|
| 12-week Progression Free Survival (PFS) | Liposarcomas | 69.6 | 90% Confidence Interval 54.5 to 89.0 | percentage of participants | |
| 12-week Progression Free Survival (PFS) | Leiomyosarcomas | 36.8 | 90% Confidence Interval 22.5 to 69.4 | percentage of participants | |
| 12-week Progression Free Survival (PFS) | Undifferentiated Pleomorphic Sarcomas | 52.6 | 90% Confidence Interval 36.8 to 75.3 | percentage of participants | |
| Median Overall Survival (OS) | Liposarcomas | 97.6 | 90% Confidence Interval 65.4 to NA | Weeks | |
| Median Overall Survival (OS) | Leiomyosarcomas | 59.1 | 90% Confidence Interval 38.1 to NA | Weeks | |
| Median Overall Survival (OS) | Undifferentiated Pleomorphic Sarcomas | NA | 90% Confidence Interval 39.9 to NA | Weeks | |
| Objective Response Rate(ORR) | Liposarcomas | 0.25 | 90% Confidence Interval 0.104 to 0.456 | proportion of participants | |
| Objective Response Rate(ORR) | Leiomyosarcomas | 0.47 | 90% Confidence Interval 0.274 to 0.680 | proportion of participants | |
| Objective Response Rate(ORR) | Undifferentiated Pleomorphic Sarcomas | 0.56 | 90% Confidence Interval 0.351 to 0.756 | proportion of participants | |
| Clinical Benefit Response Rate (CBR) | Liposarcomas | 0.75 | 90% Confidence Interval 0.54 to 0.90 | proportion of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liposarcomas | 20 | |
| Overall Study | STARTED | Leiomyosarcomas | 19 | |
| Overall Study | STARTED | Undifferentiated Pleomorphic Sarcomas | 18 | |
| Overall Study | COMPLETED | Liposarcomas | 1 | |
| Overall Study | COMPLETED | Leiomyosarcomas | 0 | |
| Overall Study | COMPLETED | Undifferentiated Pleomorphic Sarcomas | 1 | |
| Overall Study | NOT COMPLETED | Liposarcomas | 19 | |
| Overall Study | NOT COMPLETED | Leiomyosarcomas | 19 | |
| Overall Study | NOT COMPLETED | Undifferentiated Pleomorphic Sarcomas | 17 |
Source ClinicalTrials.gov
Adverse events699
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 | Anemia | Blood and lymphatic system disorders | Liposarcomas | 20 | 20 | |
| other | Anemia | Blood and lymphatic system disorders | Leiomyosarcomas | 19 | 19 | |
| other | Anemia | Blood and lymphatic system disorders | Undifferentiated Pleomorphic Sarcomas | 18 | 18 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Liposarcomas | 0 | 20 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Leiomyosarcomas | 5 | 19 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Undifferentiated Pleomorphic Sarcomas | 1 | 18 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Liposarcomas | 2 | 20 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Leiomyosarcomas | 0 | 19 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Undifferentiated Pleomorphic Sarcomas | 2 | 18 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Liposarcomas | 4 | 20 |
1 to 10 of 699Source ClinicalTrials.gov
See all 699 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liposarcomas | 10 | 20 |
| Total, all-cause mortality | Leiomyosarcomas | 12 | 19 |
| Total, all-cause mortality | Undifferentiated Pleomorphic Sarcomas | 8 | 18 |
| Total, other adverse events | Liposarcomas | 20 | 20 |
| Total, other adverse events | Leiomyosarcomas | 19 | 19 |
| Total, other adverse events | Undifferentiated Pleomorphic Sarcomas | 18 | 18 |
| Total, serious adverse events | Liposarcomas | 9 | 20 |
| Total, serious adverse events | Leiomyosarcomas | 8 | 19 |
| Total, serious adverse events | Undifferentiated Pleomorphic Sarcomas | 8 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38236580 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03899805
GET https://conductscience.org/api/trials/v1/NCT03899805/events?page=2