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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

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Overall survival

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2030