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

NCT03599453 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-07-18

No results posted yet for this study

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

Conditions

  • Triple -Negative Breast Cancer
  • Estrogen Receptor Negative
  • HER2/Neu Negative
  • Anatomic Stage IV Breast Cancer AJCC
  • Progesterone Receptor Negative

Interventions

PROCEDURE

Biopsy

Undergo Biopsy

PROCEDURE

Chemokine Modulation Therapy

Undergo chemokine modulation therapy

DRUG

Celecoxib

Given by mouth

BIOLOGICAL

Recombinant Interferon Alfa-2b

Given intravenously

DRUG

Rintatolimod

Given intravenously

BIOLOGICAL

Pembrolizumab

Given intravenously

Sponsors & Collaborators

Principal Investigators

  • Shipra Gandhi, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2020-09-02
Completion
2023-03-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599453 on ClinicalTrials.gov