Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Triple-Negative Breast Cancer, Breast Cancer

In brief

Study combination use of cisplatin plus romidepsin and nivolumab in metastatic triple negative breast cancer (TNBC) or BRCA mutation-associated locally recurrent or metastatic breast cancer

Key facts

Study ID: NCT02393794
Run by: Priyanka Sharma
People needed: 51
Starts: 2015-07-17
Expected to finish: 2026-07-01
Last updated by the study team: 2025-10-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet at least one of the following two criteria:
Histologically proven TNBC
Confirmed germline BRCA1 or BRCA2 mutation, regardless of subtype of breast cancer
Breast cancer that is either stage III disease not amenable to curative therapy or stage IV
Have at least one measurable lesion of ≥ 2 cm by conventional methods or ≥ 1 cm on spiral CT
No limit to prior therapy for metastatic breast cancer. Prior treatment with cisplatin is excluded, unless prior cisplatin treatment was given in the neo/adjuvant setting. All other platinum compounds are allowed as long as it has been 6 months since last platinum exposure.
All patients should have received at least one line of chemotherapy in either the advanced or adjuvant setting and hormonal therapy (where appropriate). Participants who have previously been treated with endocrine therapy only, and later develop triple negative disease are eligible as long as they have had one line of chemotherapy in either the advanced or adjuvant setting.
Eastern Oncology Cooperative Group (ECOG) Performance status of ≥ 2
Laboratory values as follows:
absolute neutrophil count ≥ 1,500/uL (microliter)
platelets ≥ 100,000/uL (no transfusion allowed within 2 weeks)
hemoglobin > 9 g/dL (which may be reached by transfusion)
total bilirubin within normal range or ≤ 1.5 x IULN (Institutional Upper Limit of Normal) if liver metastases
total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in subjects with Gilbert's Syndrome
aspartate aminotransferase (AST) (SGOT) /Alanine transaminase (ALT) (SPGT) ≤ 2.5 x IULN or ≤ 5 x IULN if liver metastases
Serum creatinine ≤ 1.5 x IULN
International Normalized Ratio (INR) ≤ 1.5
Serum potassium > 3.8 mmol/L
Serum magnesium >1.8 mg/dL
IV bisphosphonate and denosumab for bony metastatic disease is allowed
Radiation to bony metastases is allowed ≥ 14 days before starting study treatment
Subjects with previously treated brain metastasis who are free of central nervous system (CNS) symptoms and are ≥ 14 days from treatment of brain metastasis are eligible.
Women of child bearing potential and their partners must use contraception prior to study entry, continuing for 5 months after treatment.

You may not qualify if…

Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, biologic, targeted therapy, or any investigational therapy within either 14 days or 5 half-lives (whichever is shorter), prior to study drug administration.
Subjects who have not recovered to within one grade level (not to exceed Grade 2) of their baseline following a significant adverse event or toxicity attributed to prior treatment.
Other medical or psychiatric disorder placing the subject at undue risk for treatment complications
Subject is pregnant or lactating
Subject has previously been treated with a Histone deacetylases (HDAC) inhibitor, PD-1 inhibitor, PD-L1 inhibitor, PD-L2 inhibitor, CTLA-4 inhibitor, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
Subject tests positive for hepatitis B or C indicating acute or chronic infection
Subject has known history of testing positive for HIV or AIDS
Subject has inflammatory breast cancer
Subject has a known hypersensitivity to any of the excipients of nivolumab, cisplatin or romidepsin
Subject has a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer or prior ovarian/breast cancer in patients with BRCA associated breast cancer).
Subject is classified into Child-Pugh Class C
Subject has active, uncontrolled infection
Subject has symptomatic/untreated CNS disease
Subject has an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Subject has active cardiac disease or a history of cardiac dysfunction, including:
Congenital long QT syndrome
Corrected QT interval (QTc) interval ≥ 500 ms on the screening ECG (using the corrected QT interval to Fridericia's formula [QTcF])
Myocardial infarction within 6 months of Cycle 1 Day 1 (C1D1).
Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
Symptomatic coronary artery disease (CAD)
An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥ 2 mm, measured from isoelectric line to the ST segment).
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction < 40% by Multi Gated Acquisition Scan (MUGA) or < 50% by echocardiogram and/or MRI
A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD)
Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes
Uncontrolled hypertension, i.e., blood pressure (BP) of ≥ 160/95; subjects who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria

Where it is running

University of Kansas Cancer Center - Clinical Research Center — Fairway, Kansas, United States
University of Kansas Cancer Center - West — Kansas City, Kansas, United States
University of Kansas Cancer Center - Overland Park — Overland Park, Kansas, United States
University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States
University of Kansas Cancer Center - South — Kansas City, Missouri, United States
University of Kansas Cancer Center - North — Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.