Pembrolizumab and CXCR4 Antagonist BL-8040 in Treating Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02907099|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma Recurrent Pancreatic Adenocarcinoma Stage IV Pancreatic Cancer AJCC v6 and v7||Drug: CXCR4 Antagonist BL-8040 Biological: Pembrolizumab Other: Pharmacological Study||Phase 2|
I. To assess the overall response rate (complete response or partial response) after treatment with CXCR4 antagonist BL-8040 (BL-8040) and pembrolizumab.
I. To determine the ability of BL-8040 by itself and in combination with pembrolizumab to increase T cell infiltration into the tumor.
II. To determine if BL-8040 treatment results in increases in circulating immune cells.
III. To estimate the safety and tolerability of intravenous administration of pembrolizumab in combination with sub-cutaneously injected BL-8040 in subjects with advanced pancreatic cancer.
I. To evaluate overall response rate (ORR) per immune-related (ir) Response Evaluation Criteria in Solid Tumors (RECIST) and duration of response (DOR), disease control rate (DCR), time to progression (TTP), progression free survival (PFS), and overall survival (OS) per RECIST and irRECIST assessed by MD Anderson investigators.
II. To explore the association between PD-L1 expression by immunohistochemistry, shed PD-L1 level, somatic gene expression profiling and antitumor efficacy of pembrolizumab based on RECIST 1.1 imaging criteria as well as overall survival.
III. To explore the relationship between genomic variation and response to the treatment administered.
IV. Tissue and blood immune monitoring will be conducted through our immune platform group as detailed per the biomarker section based on 3 biopsies done at the following time points: 1) pre-treatment, 2) during the third week of cycle 2 or beginning of cycle 3, and 3) voluntary upon end of cycle 1 (BL-8040 [BL] monotherapy) on days 10 to 14.
Patients receive CXCR4 antagonist BL-8040 subcutaneously (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 intravenously (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.
After completion of study treatment, patients are followed up at 30 days and then every 10 and 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIb Pilot Study to Assess the Efficacy, Safety, and Pharmacodynamics Effects of Pembrolizumab and BL-8040 in Patients With Metastatic Pancreatic Cancer|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Treatment (CXCR4 antagonist BL-8040, pembrolizumab)
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.
Drug: CXCR4 Antagonist BL-8040
Other: Pharmacological Study
- Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 3 years ]The estimate of the ORR, along with its 95% confidence interval based on the Clopper-Pearson method 32, will be provided. Simon's 2-stage design will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907099
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David R Fogelman||M.D. Anderson Cancer Center|