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