Overview

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

Status:
Active, not recruiting
Trial end date:
2022-07-06
Target enrollment:
0
Participant gender:
Female
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
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Collaborator:
AIM ImmunoTech Inc.
Treatments:
Benzenesulfonamide
Celecoxib
Immunoglobulin G
Immunoglobulins
Interferon alpha-2
Interferon-alpha
Interferons
Pembrolizumab
Poly I-C
poly(I).poly(c12,U)
Criteria
Inclusion Criteria:

- Have pathologically confirmed diagnosis of unresectable or metastatic TNBC with no
curative treatment options

- Have been informed of other treatment options

- Patient has lesion that can be biopsied and is willing to undergo the procedure as
part of the protocol

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1

- Participants of child-bearing potential must agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study
entry. Should a woman become pregnant or suspect she is pregnant while she or her
partner is participating in this study, she should inform her treating physician
immediately

- Ability to swallow and retain oral medication

- Have measurable disease per RECIST 1.1 criteria present

- Any line of therapy allowed, radiologically confirmed progression on prior therapy

- No cancer-directed therapy for at least 3 weeks prior to study treatment
(bone-directed therapies are allowed)

- Platelets >= 100,000/uL

- Hemoglobin >= 9.0 g/dL

- Absolute neutrophil count (ANC) >= 1500/uL

- Total bilirubin =< institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x
institutional ULN

- Creatinine < ULN OR creatinine clearance >= 50 mL/min per Cockcroft-Gault Equation for
patients with creatinine levels greater than ULN

- Participant or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Patients currently treated with systemic immunosuppressive agents, including steroids
(> than equivalent of 10 mg daily of prednisone), are ineligible until 3 weeks after
removal from immunosuppressive treatment (inhaled steroids are allowed)

- Patients with active autoimmune disease or history of transplantation

- Pregnant or nursing female participants

- Unwilling or unable to follow protocol requirements

- Patients with known serious mood disorders (Major depression diagnosis is an
exclusion. Other stable mood disorders on stable therapy for > 6 months or not
requiring therapy may be allowed after consultation with PI

- Cardiac risk factors including:

- Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial
infarction, or ischemia) within 3 months of signing consent

- Patients with a New York Heart Association classification of III or IV

- History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or
upper gastrointestinal perforation within the past 3 years

- Prior allergic reaction or hypersensitivity to nonsteroidal antiinflammatory drugs
(NSAIDs) or any drugs administered on protocol

- Prior immunotherapy with anti-PD1/PDL1 therapy for the mTNBC

- Any condition which in the Investigator's opinion deems the participant an unsuitable
candidate to receive study drug

- Any patients with a positive Antinuclear Antibodies test will be excluded from study