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SarcomaPhase 2NCT03899805

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

A Phase 2 study testing Eribulin and Pembrolizumab in people with Sarcoma and Liposarcoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Liposarcoma, Leiomyosarcoma
What is being tested?
Eribulin and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesUnited States
Study dates
4 Jun 2019to 16 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed liposarcoma, leiomyosarcoma, or undifferentiated/unclassified pleomorphic sarcoma by a Dana-Farber Cancer Institute or Massachusetts General Hospital pathologist
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
  • Participants must have received at least one prior line of chemotherapy. No limit on prior lines of therapy.
  • Age ≥ 18 years.
  • ECOG performance status of 0 or 1 (see Appendix A).
  • Participants must have normal organ and marrow function as defined below:
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  • leukocytes ≥3,000/mcL
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • Hemoglobin ≥ 8 g/dL within the first 2 weeks prior to the first dose of study drugs, transfusion is allowed.
  • total bilirubin ≤1.5× institutional upper limit of normal (ULN) (except participants with Gilbert Syndrome, who can have total bilirubin <3.0 mg/dL)
  • AST(SGOT)/ALT(SGPT)<2.5 x ULN in a participant with no documented liver metastases; ALT and AST <5.0 x ULN in a participant with documented liver metastases
  • creatinine ≤1.5× ULN OR
  • creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (using the Cockcroft-Gault Formula below):
  • Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
  • Male CrCl = (140 - age in years) x weight in kg 72 x serum creatinine in mg/dL
  • Available archival tumor tissue including Formalin-fixed, paraffin embedded (FFPE) or fresh frozen, or be willing to undergo baseline biopsy for tumor tissue correlative biomarker studies.
  • The effects of eribulin and pembrolizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A male participant must agree to use a contraception as detailed in Appendix G of this protocol during the treatment period and for at least 20 weeks, corresponding to the time needed to eliminate any study treatments, plus an additional 120 days (a spermatogenesis cycle) after the last dose of study treatment. A female participant is eligible to participate if she is not pregnant (see Appendix G), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix G OR
  • A WOCBP who agrees to follow the contraceptive guidance in Appendix G during the treatment period and for at least 20 weeks plus an additional 30 days (a menstruation cycle) after the last dose of study treatment.
  • WOCBP should use an adequate method to avoid pregnancy for at least 20 weeks plus an additional 30 days after the last dose of investigational drug. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the start of Eribulin and Pembrolizumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Participants who have had standard chemotherapy or radiotherapy within 3 weeks prior to entering the study.
  • Participants who have not recovered from adverse events (grade 2 or higher toxicities) due to agents administered, radiotherapy, or surgery more than 3 weeks earlier, with the exception of alopecia.
  • Previous treatment with eribulin or any anti-PD-1, PD-L1, or PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
  • Participants who are currently participating in or have participated in a study of an investigational agent or have used an investigational device within 3 weeks prior to the first dose of study treatment.
  • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.
  • Known brain metastases that are untreated, symptomatic or require therapy to control symptoms. Participants with previously diagnosed brain metastases are eligible if they have completed treatment at least 4 weeks prior to registration, are neurologically stable and have not experienced any new neurologic symptoms for the last 4 weeks prior to study entry, and have recovered from the effects of radiotherapy or surgery. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery, surgery, or a combination as deemed appropriate by the treating physician.
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  • Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Inability to comply with study and/or follow-up procedures.
  • History of severe hypersensitivity reaction (≥Grade 3) to any monoclonal antibody.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Eribulin or Pembrolizumab.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations which in the PI's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the trial and study requirements.
  • Pregnant women (WOCBP who had a positive serum pregnancy test on screening or 72 hours prior to initiation of study protocol) are excluded from this study because the effects of Eribulin and Pembrolizumab on the developing fetus are unknown. There is the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Eribulin and Pembrolizumab, breastfeeding should be discontinued if the mother is treated with Eribulin and Pembrolizumab.
  • Because the effects of pembrolizumab on chronic viral infection are not well known, participants should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) (true positive) or known acquired immunodeficiency syndrome (AIDS) or if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  • Participants with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, are excluded. These include but are not limited to participants with a history of immune related neurologic disease such as multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, or myasthenia gravis; participants with a history of systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, or hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome. These participants should be excluded because of the risk of recurrence or exacerbation of disease. Participants with vitiligo or endocrine deficiencies, including thyroiditis managed with replacement hormones such as physiologic corticosteroids, are eligible. Participants with rheumatoid arthritis or other arthropathies; Sjögren's syndrome; psoriasis controlled with topical medication; or participants with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Participants are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
  • Participants should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intraarticular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if <10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
  • Participants with a history of pneumonitis or interstitial lung disease.
  • History of primary immunodeficiency or solid organ transplantation.
  • Participants who have had evidence of active or acute diverticulitis, intra-abdominal abscess, GI obstruction, or fistula or abdominal carcinomatosis (which are known risk factors for bowel perforation) should be evaluated for the potential need for additional treatment before coming on study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug, or in the case of this study, combination of drugs, to learn whether the combination of drugs works in treating a specific disease. "Investigational" means that the combination of drugs is being studied.

The primary purpose of this research study is to test the safety and effectiveness of eribulin and pembrolizumab in combination for controlling this cancer

The FDA (the U.S. Food and Drug Administration) has approved eribulin for the treatment of liposarcoma, based on a phase III study that compared eribulin and dacarbazine in the treatment of liposarcoma and leiomyosarcoma. The FDA has not approved pembrolizumab for this specific disease but it has been approved for other uses. A phase II study showed rare responses of liposarcoma and undifferentiated pleomorphic sarcoma to treatment with pembrolizumab. While eribulin in combination with pembrolizumab has not previously been tested in the treatment of liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma, other research studies and laboratory experiments and information from those studies suggest that the combination of these drugs may help to stop cancer cells from growing. Chemotherapy treatment with eribulin may increase the response to immunotherapy with pembrolizumab

Being tested
Eribulin, Pembrolizumab
Keywords
Sarcoma
Medical subject headings
Sarcoma, Liposarcoma, Leiomyosarcoma, Histiocytoma, Malignant Fibrous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EribulinDrug

    Also called Halaven

    The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).

  • PembrolizumabDrug

    Also called Keytruda

    The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.

Study groups in NCT03899805
Study groupRoleWhat they receive
LiposarcomasExperimental* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
Receives: Drug: Eribulin; Drug: Pembrolizumab
LeiomyosarcomasExperimental* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
Receives: Drug: Eribulin; Drug: Pembrolizumab
Undifferentiated Pleomorphic sarcomasExperimental* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
Receives: Drug: Eribulin; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-week Progression Free Survival (PFS)

    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.

    Measured: 12 weeks

Secondary outcomes (3)

  1. Median Overall Survival (OS)

    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.

    Measured: Up to 2 years

  2. Objective Response Rate(ORR)

    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.

    Measured: Up to 2 years

  3. Clinical Benefit Response Rate (CBR)

    CBR is defined as the proportion of participants who reached stable disease, partical response and complete resposne during treatment based on RECIST 1.1

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start4 Jun 2019
  3. Primary completion16 Jul 2024
  4. Study completion16 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03899805
Sponsor's protocol ID
19-082
Status last verified
Aug 2025
First submitted
1 Apr 2019
Last updated
28 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Publications

  • Haddox CL, Nathenson MJ, Mazzola E, Lin JR, Baginska J, Nau A, Weirather JL, Choy E, Marino-Enriquez A, Morgan JA, Cote GM, Merriam P, Wagner AJ, Sorger PK, Santagata S, George S. Phase II Study of Eribulin plus Pembrolizumab in Metastatic Soft-tissue Sarcomas: Clinical Outcomes and Biological Correlates. Clin Cancer Res. 2024 Apr 1;30(7):1281-1292. doi: 10.1158/1078-0432.CCR-23-2250.

    PubMed 38236580

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eribulin and Pembrolizumab in people with Sarcoma and Liposarcoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-week Progression Free Survival (PFS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03899805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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