Trial Outcomes & Findings for Pembrolizumab and CXCR4 Antagonist BL-8040 in Treating Patients With Metastatic Pancreatic Cancer (NCT NCT02907099)
NCT ID: NCT02907099
Last Updated: 2025-02-19
Results Overview
To assess the overall response rate (complete response or partial response) PER RECIST 1.0 after treatment with CXCR4 antagonist BL-8040 (BL-8040) and pembrolizumab
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
3 years
Results posted on
2025-02-19
Participant Flow
UT Md Anderson Cancer Center
Participant milestones
| Measure |
Pembrolizumab Plus BL-8040
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Pembrolizumab Plus BL-8040
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Screen Fail
|
2
|
Baseline Characteristics
Pembrolizumab and CXCR4 Antagonist BL-8040 in Treating Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab Plus BL-8040
n=20 Participants
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsTo assess the overall response rate (complete response or partial response) PER RECIST 1.0 after treatment with CXCR4 antagonist BL-8040 (BL-8040) and pembrolizumab
Outcome measures
| Measure |
Pembrolizumab Plus BL-8040
n=15 Participants
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Overall Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: pre treatment at baseline and post treatment (2 months)Population: Metastatic Pancreatic Cancer (mPC)
Biomarker Analysis (TCR analysis, flow cytometry panel) of biopsy core samples was utilized to detect the presence and amount of T Cell infiltration into the tumor tissue.
Outcome measures
| Measure |
Pembrolizumab Plus BL-8040
n=6 Participants
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Quantity of T-Cell Infiltration Pre-treatment and Post Treatment Following Administration of BL-8040 by Itself and BL-8040 With Pembrolizumab
PRE TREATMENT
|
52.5 T-cells/mm^2
Interval 7.0 to 620.0
|
|
Quantity of T-Cell Infiltration Pre-treatment and Post Treatment Following Administration of BL-8040 by Itself and BL-8040 With Pembrolizumab
POST TREATMENT
|
112.5 T-cells/mm^2
Interval 20.0 to 420.0
|
SECONDARY outcome
Timeframe: pre treatment and post treatment, up to 3 yearsBiomarker Analysis (TCR analysis, flow cytometry panel) of biopsy core samples was utilized to detect the Quantity of circulating T-Cells into the tumor tissue.
Outcome measures
| Measure |
Pembrolizumab Plus BL-8040
n=6 Participants
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Quantity of Circulating T-Cells Pre-treatment and Post Treatment Following Administration of BL-8040
PRE TREATMENT
|
275 T-cells/mm^2
Interval 100.0 to 2550.0
|
|
Quantity of Circulating T-Cells Pre-treatment and Post Treatment Following Administration of BL-8040
POST TREATMENT
|
450 T-cells/mm^2
Interval 150.0 to 650.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Metastatic Pancreatic Cancer (mPC).
Utilizing CTCAE v4.0, the number of treatment-related adverse events was recorded.
Outcome measures
| Measure |
Pembrolizumab Plus BL-8040
n=15 Participants
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
|
9 Participants
|
Adverse Events
Pembrolizumab Plus BL-8040
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pembrolizumab Plus BL-8040
n=15 participants at risk
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • 3 years
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • 3 years
|
|
Investigations
Alkaline Phosphatase increased
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • 3 years
|
Other adverse events
| Measure |
Pembrolizumab Plus BL-8040
n=15 participants at risk
In cycle 1, BL8040 was administered1.25 mg/kg s.c. daily on days 1-5 and days 8-12. Starting with the second cycle pembrolizumab was administered on day1 (200 mg) and BL8040 was continued on days 1,4,8, and 11.
Biopsy: Pretreatment biopsies; An optional biopsy after cycle 1 (BL monotherapy) and a second mandatory biopsy after cycle 3.
|
|---|---|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • 3 years
|
|
Investigations
Alkaline Phosphatase Increased
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Ascites
|
6.7%
1/15 • 3 years
|
|
General disorders
Dyspnea
|
13.3%
2/15 • 3 years
|
|
Endocrine disorders
Abdominal Pain
|
6.7%
1/15 • 3 years
|
Additional Information
Brandon Smaglo, MD
The University of Texas MD Anderson Cancer Center
Phone: (713) 745-8763
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place