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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My sarcoma type has been confirmed by a specific hospital's pathologist.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Progression Free Survival
Secondary outcome measures
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 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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 2
~1950
Eribulin
2012
Completed Phase 3
~2700

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,307 Total Patients Enrolled
26 Trials studying Sarcoma
5,585 Patients Enrolled for Sarcoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,860 Previous Clinical Trials
5,047,797 Total Patients Enrolled
31 Trials studying Sarcoma
3,870 Patients Enrolled for Sarcoma
Suzanne George, MDPrincipal InvestigatorDana-Farber Cancer Institute
12 Previous Clinical Trials
6,705 Total Patients Enrolled
2 Trials studying Sarcoma
61 Patients Enrolled for Sarcoma

Media Library

Eribulin (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03899805 — Phase 2
Sarcoma Research Study Groups: Liposarcomas, Undifferentiated Pleomorphic sarcomas, Leiomyosarcomas
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been utilized in any prior scientific studies?

"At this time, 995 trials are being conducted to assess the efficacy of Pembrolizumab with 132 reaching Phase 3. Of those studies, Houston is hosting a number but there exist 36946 locations wherein research related to this medication is taking place."

Answered by AI

Is Pembrolizumab a safe medication for patients to use?

"Although no efficacy data is available, Pembrolizumab has been assigned a safety score of 2 due to some pre-existing evidence of its risk profile from Phase 2 trials."

Answered by AI

What is the capacity of this medical trial in terms of participants?

"At the moment, this trial is not seeking participants. First posted on May 13th 2019 and last edited November 15 2022, if you're searching for other studies, there are currently 478 leiomyosarcoma trials and 995 Pembrolizumab experiments actively recruiting patients."

Answered by AI

Are there any open slots for participation in this experimental procedure?

"This particular clinical trial has concluded its recruitment period. Initially advertised on May 13th 2019 and most recently updated November 15th 2022, participants are no longer being sought for this study. However, there are currently 478 trials related to leiomyosarcoma and 995 Pembrolizumab studies actively seeking patients."

Answered by AI

What primary afflictions is Pembrolizumab regularly employed to ameliorate?

"Pembrolizumab has been known to effectively combat malignant neoplasms, unresectable melanoma, and cases of microsatellite instability high."

Answered by AI
~4 spots leftby Aug 2024