Clinical Trials Directory

Trials / Completed

CompletedNCT03599453

Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer

Pilot Open Label Clinical Trial Evaluating the Safety and Efficacy of Chemokine Modulation to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This pilot trial studies how well chemokine modulation therapy works when given prior to pembrolizumab in treating participants with triple-negative breast cancer that has spread to other places in the body. Drugs used in chemokine modulation therapy, such as celecoxib, recombinant interferon alfa-2b, and rintatolimod, work by unleashing or enhancing the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving chemokine modulation therapy before pembrolizumab may work better in treating participants with metastatic triple-negative breast cancer

Detailed description

PRIMARY OBJECTIVES: -To evaluate the increase of CD8+ infiltration into tumor microenvironment after pre-treatment CKM regime SECONDARY OBJECTIVES: * To evaluate the overall response rate (ORR) to the combination therapy per RECIST v1.1 * To evaluate the efficacy of the chemokine modulation (CKM) in combination with pembrolizumab in patients with metastatic triple negative breast cancer (mTNBC) as compared to historic outcomes of pembrolizumab and other anti-PD1/PD-L1 therapies alone, as determined by secondary measures of efficacy including progression-free survival (PFS), overall survival (OS), and disease control rate (DCR). * To evaluate the safety profile of CKM regimen given as pre-treatment to pembrolizumab therapy in metastatic breast cancer patients using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. EXPLORATORY OBJECTIVES: * Examine the immune analysis profile of CKM and pembrolizumab combination. * Examine the relationship of infiltrating CD4+ and CD8+ T cells and other immune and genetic markers, and their associated PD-1, CD45RA or CD45RO levels. * Correlate PD-L1 expression within both neoplastic and nonneoplastic stromal elements of the tumor microenvironment to PFS, OS, ORR and adverse events (AEs). * Correlate Immune Panel results with ORR, PFS, OS and AEs. * Comparison of response assessment criteria for a prospective analysis OUTLINE: Participants undergo pre-treatment biopsy. Participants then undergo chemokine modulation therapy consisting of celecoxib orally (PO) twice daily (BID), recombinant interferon alfa-2b intravenously (IV) over 20 minutes, and rintatolimod IV over 30-60 minutes on days -11 to -9, and -4 to -2. Participants then undergo additional biopsy. Following biopsy and chemokine modulation therapy, participants receive pembrolizumab IV over 30 minutes on day 1. After completion of study treatment, participants are followed up for 90 days and then every 6 months for up to 2 years.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiopsyUndergo Biopsy
PROCEDUREChemokine Modulation TherapyUndergo chemokine modulation therapy
DRUGCelecoxibGiven by mouth
BIOLOGICALRecombinant Interferon Alfa-2bGiven intravenously
DRUGRintatolimodGiven intravenously
BIOLOGICALPembrolizumabGiven intravenously

Timeline

Start date
2019-01-09
Primary completion
2020-09-02
Completion
2023-03-21
First posted
2018-07-26
Last updated
2023-07-18

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03599453. Inclusion in this directory is not an endorsement.