Pembrolizumab for Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sarcoma+3 MorePembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Sarcoma
  • Leiomyosarcoma
  • Undifferentiated Pleomorphic Sarcoma
  • Liposarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 Years

Assessed at 12 weeks
Clinical Benefit Response Rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Objective Response Rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Week 12
Rate of Progression Free Survival
Up to 2 Years
Incidence of toxicity, grade using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Up to 2 years
Overall Survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

3 Treatment Groups

Leiomyosarcomas
1 of 3
Liposarcomas
1 of 3
Undifferentiated Pleomorphic sarcomas
1 of 3

Experimental Treatment

57 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

LeiomyosarcomasExperimental Group · 2 Interventions: Eribulin, Pembrolizumab · Intervention Types: Drug, Drug
LiposarcomasExperimental Group · 2 Interventions: Eribulin, Pembrolizumab · Intervention Types: Drug, Drug
Undifferentiated Pleomorphic sarcomasExperimental Group · 2 Interventions: Eribulin, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,676 Previous Clinical Trials
4,955,777 Total Patients Enrolled
30 Trials studying Sarcoma
3,511 Patients Enrolled for Sarcoma
Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,741 Total Patients Enrolled
25 Trials studying Sarcoma
5,257 Patients Enrolled for Sarcoma
Suzanne George, MDPrincipal InvestigatorDana-Farber Cancer Institute
9 Previous Clinical Trials
418 Total Patients Enrolled
2 Trials studying Sarcoma
61 Patients Enrolled for Sarcoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must have received at least one prior line of chemotherapy
You have hemoglobin ≥ 8 g/dL within the first 2 weeks prior to the first dose of study drugs.
You have a platelet count of at least 100,000/mcL.