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NCT03899805

A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas

Completed Phase 2 Results posted Last updated 28 August 2025
What this trial tests

Phase 2 trial testing Eribulin in Sarcoma in 57 participants. Completed in 16 July 2024.

Timeline
4 June 2019
Primary endpoint
16 July 2024
16 July 2024

Quick facts

Lead sponsorDana-Farber Cancer Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment57
Start date4 June 2019
Primary completion16 July 2024
Estimated completion16 July 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Sarcoma or Liposarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

12-week Progression Free Survival (PFS) Primary · 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 les

GroupValue95% CI
Liposarcomas69.654.5 – 89.0
Leiomyosarcomas36.822.5 – 69.4
Undifferentiated Pleomorphic Sarcomas52.636.8 – 75.3
Median Overall Survival (OS) Secondary · 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.

GroupValue95% CI
Liposarcomas97.665.4 – NA
Leiomyosarcomas59.138.1 – NA
Undifferentiated Pleomorphic SarcomasNA39.9 – NA
Objective Response Rate(ORR) Secondary · 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.

GroupValue95% CI
Liposarcomas0.250.104 – 0.456
Leiomyosarcomas0.470.274 – 0.680
Undifferentiated Pleomorphic Sarcomas0.560.351 – 0.756
Clinical Benefit Response Rate (CBR) Secondary · 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

GroupValue95% CI
Liposarcomas0.750.54 – 0.90
Leiomyosarcomas0.530.32 – 0.73
Undifferentiated Pleomorphic Sarcomas0.440.24 – 0.66

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liposarcomas
Serious: 9/20 (45%)
Deaths: 10/20
Leiomyosarcomas
Serious: 8/19 (42%)
Deaths: 12/19
Undifferentiated Pleomorphic Sarcomas
Serious: 8/18 (44%)
Deaths: 8/18

Serious adverse events (35 terms)

ReactionSystemLiposarcomasLeiomyosarcomasUndifferentiated Pleomorph…
Small intestinal obstructionGastrointestinal disorders———
Febrile neutropeniaBlood and lymphatic system disorders———
Aspartate aminotransferase increasedInvestigations———
Neutrophil count decreasedInvestigations———
DiarrheaGastrointestinal disorders———
Lipase increasedInvestigations———
Renal and urinary disorders - Other, specifyRenal and urinary disorders———
PneumonitisRespiratory, thoracic and mediastinal disorders———
AnemiaBlood and lymphatic system disorders———
Atrial fibrillationCardiac disorders———
Cardiac arrestCardiac disorders———
Abdominal painGastrointestinal disorders———
ColitisGastrointestinal disorders———
Mucositis oralGastrointestinal disorders———
Oral painGastrointestinal disorders———
Edema limbsGeneral disorders———
FatigueGeneral disorders———
Hepatic failureHepatobiliary disorders———
Abdominal infectionInfections and infestations———
Hepatitis viralInfections and infestations———
FractureInjury, poisoning and procedural complications———
Alanine aminotransferase increasedInvestigations———
Blood bilirubin increasedInvestigations———
Lymphocyte count decreasedInvestigations———
Serum amylase increasedInvestigations———
Other adverse events (198 terms — click to expand)

ReactionSystemLiposarcomasLeiomyosarcomasUndifferentiated Pleomorph…
AnemiaBlood and lymphatic system disorders———
NauseaGastrointestinal disorders———
FatigueGeneral disorders———
Neutrophil count decreasedInvestigations———
White blood cell decreasedInvestigations———
HyperglycemiaMetabolism and nutrition disorders———
HyponatremiaMetabolism and nutrition disorders———
HypertensionVascular disorders———
DiarrheaGastrointestinal disorders———
FeverGeneral disorders———
Lipase increasedInvestigations———
AnorexiaMetabolism and nutrition disorders———
HypomagnesemiaMetabolism and nutrition disorders———
Aspartate aminotransferase increasedInvestigations———
Blood lactate dehydrogenase increasedInvestigations———
Alanine aminotransferase increasedInvestigations———
CoughRespiratory, thoracic and mediastinal disorders———
Weight lossInvestigations———
ArthralgiaMusculoskeletal and connective tissue disorders———
HypophosphatemiaMetabolism and nutrition disorders———
Alkaline phosphatase increasedInvestigations———
Electrocardiogram QT corrected interval prolongedInvestigations———
Peripheral sensory neuropathyNervous system disorders———
ConstipationGastrointestinal disorders———
Platelet count decreasedInvestigations———
Serum amylase increasedInvestigations———
HypokalemiaMetabolism and nutrition disorders———
AlopeciaSkin and subcutaneous tissue disorders———
Skin and subcutaneous tissue disorders - Other, specifySkin and subcutaneous tissue disorders———
Mucositis oralGastrointestinal disorders———
Edema limbsGeneral disorders———
HypoalbuminemiaMetabolism and nutrition disorders———
DyspneaRespiratory, thoracic and mediastinal disorders———
Rash maculo-papularSkin and subcutaneous tissue disorders———
Sinus tachycardiaCardiac disorders———
PainGeneral disorders———
Muscle crampMusculoskeletal and connective tissue disorders———
Pain in extremityMusculoskeletal and connective tissue disorders———
HypocalcemiaMetabolism and nutrition disorders———
DysgeusiaNervous system disorders———

Most-reported serious reactions: Small intestinal obstruction, Febrile neutropenia, Aspartate aminotransferase increased, Neutrophil count decreased, Diarrhea, Lipase increased, Renal and urinary disorders - Other, specify, Pneumonitis.

Data from ClinicalTrials.gov NCT03899805 adverse events section.

Sponsor's own description

This research study is studying a combination of drugs (chemotherapy + Immunotherapy) as a possible treatment for liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma that has spread and has not responded to standard treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
    Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
  2. Liposarcoma: Advances in Cellular and Molecular Genetics Alterations and Corresponding Clinical Treatment.
    Yang L, Chen S, Luo P, Yan W, et al · · 2020 · cited 40× · PMID 31892977 · DOI 10.7150/jca.36380
  3. Soft Tissue Sarcoma: An Insight on Biomarkers at Molecular, Metabolic and Cellular Level.
    Pillozzi S, Bernini A, Palchetti I, Crociani O, et al · · 2021 · cited 29× · PMID 34207243 · DOI 10.3390/cancers13123044
  4. Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
    Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5
  5. Phase II Study of Eribulin plus Pembrolizumab in Metastatic Soft-tissue Sarcomas: Clinical Outcomes and Biological Correlates.
    Haddox CL, Nathenson MJ, Mazzola E, Lin JR, et al · · 2024 · cited 24× · PMID 38236580 · DOI 10.1158/1078-0432.ccr-23-2250
  6. Is immunotherapy in the future of therapeutic management of sarcomas?
    Clemente O, Ottaiano A, Di Lorenzo G, Bracigliano A, et al · · 2021 · cited 24× · PMID 33902630 · DOI 10.1186/s12967-021-02829-y
  7. Role of PD-1/PD-L1 signaling axis in oncogenesis and its targeting by bioactive natural compounds for cancer immunotherapy.
    Godiyal Y, Maheshwari D, Taniguchi H, Zinzuwadia SS, et al · · 2024 · cited 21× · PMID 39690423 · DOI 10.1186/s40779-024-00586-9
  8. Targeting the Molecular and Immunologic Features of Leiomyosarcoma.
    Cope BM, Traweek RS, Lazcano R, Keung EZ, et al · · 2023 · cited 20× · PMID 37046760 · DOI 10.3390/cancers15072099

Verify or expand the search:

Other trials of Eribulin

Trials testing the same drug.

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Trials by the same sponsor.

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