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Anti-tumor antibiotic

Immunotherapy + Chemotherapy for Sarcoma

Phase 3
Recruiting
Led By Seth M Pollack
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to documented progression (per response evaluation criteria in solid tumors version 1.1) or death from any cause without prior progression, up to 5 years
Awards & highlights

Summary

"This trial is comparing the effects of combining immunotherapy (pembrolizumab) with chemotherapy (doxorubicin) versus using chemotherapy alone to treat patients with undifferentiated pleomorphic sar

Who is the study for?
This trial is for adults over 18 with specific aggressive sarcomas, like undifferentiated pleomorphic sarcoma or malignant fibrous histiocytoma, that have spread and can't be surgically removed. Women must have started menstruating to participate.
What is being tested?
The study compares the effects of combining immunotherapy (pembrolizumab) with chemotherapy (doxorubicin) versus using chemotherapy alone on patients with certain advanced sarcomas to see if it improves survival without disease progression.
What are the potential side effects?
Potential side effects include damage to DNA from doxorubicin which may kill tumor cells but also affect healthy ones, while pembrolizumab might cause immune system reactions against normal tissues as well as cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to documented progression (per response evaluation criteria in solid tumors version 1.1) or death from any cause without prior progression, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to documented progression (per response evaluation criteria in solid tumors version 1.1) or death from any cause without prior progression, up to 5 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
Progression free survival (PFS)
Secondary outcome measures
Overall survival

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (doxorubicin and pembrolizumabExperimental Treatment6 Interventions
Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan during screening, as well as standard imaging scans and blood sample collection throughout the study.
Group II: Arm B (doxorubicin)Active Control5 Interventions
Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan during screening, as well as standard imaging scans and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Biospecimen Collection
2004
Completed Phase 3
~2020
Doxorubicin
2012
Completed Phase 3
~8030
Echocardiography
2013
Completed Phase 4
~11580
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,820 Total Patients Enrolled
Seth M PollackPrincipal InvestigatorECOG-ACRIN Cancer Research Group
~120 spots leftby Jun 2026
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