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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02907099
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma
  • Recurrent Pancreatic Adenocarcinoma
  • Stage IV Pancreatic Cancer AJCC v6 and v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CXCR4 Antagonist BL-8040 — DRUG
    Given SC
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This pilot phase IIb trial studies how well pembrolizumab and CXCR4 antagonist BL-8040 work in treating patients with pancreatic cancer that has spread to other places. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CXCR4 antagonist BL-8040 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and CXCR4 antagonist BL-8040 may work better in treating patients with pancreatic cancer.

Key Dates

Start date
Dec 1, 2016
Status verified
Nov 2024
Primary completion
Oct 6, 2023
Completion
Oct 6, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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M D Anderson Cancer Center· Houston, TX

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