Pembrolizumab for Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sarcoma+2 More
Pembrolizumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if doxorubicin and pembrolizumab are safe and effective in treating soft tissue sarcoma.

Eligible Conditions
  • Sarcoma
  • Soft Tissue Sarcoma, Child
  • Soft Tissue Sarcoma, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 60 months

24 months
Response - DoR
Response - ORR
Survival - PFS
60 months
Survival - OS
Day 90
Toxicity rate

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

1 Treatment Group

Pembrolizumab + doxorubicin
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Pembrolizumab + doxorubicinExperimental Group · 2 Interventions: Pembrolizumab, Doxorubicin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months

Who is running the clinical trial?

Michael LivingstonLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,656 Previous Clinical Trials
4,954,128 Total Patients Enrolled
30 Trials studying Sarcoma
3,538 Patients Enrolled for Sarcoma
Wake Forest University Health SciencesLead Sponsor
1,113 Previous Clinical Trials
1,129,544 Total Patients Enrolled
6 Trials studying Sarcoma
353 Patients Enrolled for Sarcoma
Michael Livingston, MDPrincipal InvestigatorLevine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)
Megan Jagosky, MDPrincipal InvestigatorLevine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Be willing to sign a form that says you understand the risks and benefits of the trial and agree to participate.
The patient must not have received prior treatment with an anthracycline chemotherapy (eg, doxorubicin) and/or anti-PD-1/PD-L1 therapy.
All subjects who have a tumor that is accessible will be asked to provide a fresh tumor biopsy if it is safe to do so, in the opinion of the investigator
The subject should have adequate organ function as indicated by the laboratory values in Table 1 of the protocol
In order to participate in this study, you must be at least 12 years old on the day you sign the informed consent form
ECOG performance status is either 0 or 1.
In order to be eligible for this study, patients must have a histologically confirmed diagnosis of an unresectable or metastatic soft tissue sarcoma that is not amenable to curative treatment with surgery or radiotherapy
The individual may have received any number of prior treatments that involved Systemic Cytotoxic Therapies for their metastatic cancer that was not operable.
Patients must have at least one radiologically measurable lesion as per RECIST 1.1 guidelines, which is defined as a lesion that is 10mm in longest diameter or a lymph node that is 15mm in short axis imaged by CT scan or MRI
The Investigator found that the life expectancy of the mice was at least 3 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.