Pembrolizumab and CXCR4 Antagonist BL-8040 in Treating Patients With Metastatic Pancreatic Cancer

Houston, TX

Phase 2

Waitlist Available

Led By Brandon G. Smaglo, MD

Research Sponsored by M.D. Anderson Cancer Center

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 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs to treat pancreatic cancer. One drug is pembrolizumab, which helps the body's immune system attack the cancer. The other drug is CXCR4 antagonist BL-8040, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Eligible Conditions

Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Overall Response Rate

Secondary study objectives

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Quantity of Circulating T-Cells Pre-treatment and Post Treatment Following Administration of BL-8040

Quantity of T-Cell Infiltration Pre-treatment and Post Treatment Following Administration of BL-8040 by Itself and BL-8040 With Pembrolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CXCR4 antagonist BL-8040, pembrolizumab)Experimental Treatment3 Interventions

Patients receive CXCR4 antagonist BL-8040 SC on days 1-5 and 8-12 of cycle 1 and days 1, 4, 8, and 11 of subsequent cycles. Beginning cycle 2, patients also receive pembrolizumab IV over about 30 minutes on day 1. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CXCR4 Antagonist BL-8040

2016

Completed Phase 2

~20

Pembrolizumab

2017

Completed Phase 3

~2630