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Microtubule Inhibitor

Eribulin + Pembrolizumab for Sarcoma

Phase 2
Waitlist Available
Led By Suzanne George, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hemoglobin ≥ 8 g/dL within the first 2 weeks prior to the first dose of study drugs, transfusion is allowed.
Participants must have normal organ and marrow function
Must not have
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
Participants who have had standard chemotherapy or radiotherapy within 3 weeks prior to entering the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma that has Spread and did not respond to standard treatment.

Who is the study for?
Adults over 18 with certain types of sarcoma (liposarcoma, leiomyosarcoma, or pleomorphic sarcoma) that have spread and are resistant to standard treatment. Participants must have had prior chemotherapy, be in good physical condition (ECOG 0-1), and have normal organ/marrow function. They should not have used the study drugs before or other similar treatments, nor should they have active autoimmune diseases or severe allergies to trial drugs.
What is being tested?
The trial is testing a combination of Eribulin (chemotherapy) and Pembrolizumab (immunotherapy) on patients with advanced soft tissue sarcomas who haven't responded well to previous treatments. The goal is to see if this drug duo can effectively treat these cancers.
What are the potential side effects?
Possible side effects include fatigue, nausea, hair loss from chemotherapy; immune-related issues like rash or thyroid problems from immunotherapy; as well as potential infusion reactions such as fever or chills during drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hemoglobin level is at least 8 g/dL, transfusions included.
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My organs and bone marrow are functioning normally.
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I have at least one tumor that can be measured.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My sarcoma type has been confirmed by a specific hospital's pathologist.
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I have undergone at least one chemotherapy treatment.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have undergone at least one chemotherapy treatment before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have recovered from major side effects of previous treatments.
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I haven't had chemotherapy or radiotherapy in the last 3 weeks.
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I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.
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I am allergic to medications similar to Eribulin or Pembrolizumab.
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I have not been treated with eribulin or drugs targeting immune checkpoints.
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I have or had an autoimmune disease that could come back.
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I have had issues like severe gut infections, blockages, or cancer spread in my abdomen.
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I do not have any uncontrolled illnesses.
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I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.
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I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Progression Free Survival
Secondary study objectives
Clinical Benefit Response Rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Incidence of toxicity, grade using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Objective Response Rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Undifferentiated Pleomorphic sarcomasExperimental Treatment2 Interventions
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
Group II: LiposarcomasExperimental Treatment2 Interventions
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
Group III: LeiomyosarcomasExperimental Treatment2 Interventions
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Eribulin
2012
Completed Phase 3
~2740

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,180 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,007 Previous Clinical Trials
5,185,043 Total Patients Enrolled
Suzanne George, MDPrincipal InvestigatorDana-Farber Cancer Institute
12 Previous Clinical Trials
6,705 Total Patients Enrolled

Media Library

Eribulin (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03899805 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Leiomyosarcomas, Undifferentiated Pleomorphic sarcomas, Liposarcomas
Soft Tissue Sarcoma Clinical Trial 2023: Eribulin Highlights & Side Effects. Trial Name: NCT03899805 — Phase 2
Eribulin (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03899805 — Phase 2
~6 spots leftby Aug 2025
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