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Triple-Negative Breast CancerPhase 1/2NCT02393794

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

A Phase 1/2 study testing Romidepsin, Cisplatin and Nivolumab in people with Triple-Negative Breast Cancer and Breast Cancer, run by Priyanka Sharma at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple-Negative Breast Cancer, Breast Cancer
What is being tested?
Romidepsin, Cisplatin and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
7 sitesUnited States
Study dates
17 Jul 2015to Jul 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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
  • Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
  • Subjects taking drugs leading to significant QT prolongation
  • Concomitant use of CYP3A4 inhibitors
  • Subject has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects
  • Subject is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug or who have not fully recovered from side effects of such treatment. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Subject is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A. The subject must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment.
  • Subject is currently receiving warfarin or other coumarin derived anti-coagulant for treatment. Therapy with heparin, low molecular weight heparin (LMWH), Factor Xa or fondaparinux is allowed.
  • Subjects with baseline peripheral neuropathy that exceeds Grade 1.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Kansas Cancer Center - Clinical Research Center

    Fairway, Kansas, 66205

  • University of Kansas Cancer Center - West

    Kansas City, Kansas, 66112

  • University of Kansas Cancer Center - South

    Kansas City, Missouri, 64131

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: Phase I/II Study of Cisplatin Plus Romidepsin and Nivolumab in Metastatic Triple Negative Breast Cancer or BRCA Mutation-Associated Locally Recurrent or Metastatic Breast Cancer

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

Read the detailed description

Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Despite recent improvement in the treatment of breast cancer, 40,000 women per year still die in the U.S.as a result of breast cancer. Once the disease has gotten worse (progressed) after standard chemotherapy treatments, there are limited treatment options and the likelihood for patients to recover is very small.

The study will be done in two phases:

Phase I will determine the highest dose of romidepsin that is safe and tolerable to take in combination with cisplatin.

Phase II will determine if taking romidepsin (at the dose determined in Phase I) in combination with cisplatin and nivolumab is safe and effective in treating patients with breast cancer.

Phase I will complete before Phase II begins.

Being tested
Romidepsin, Cisplatin, Nivolumab
Keywords
BRCA1, BRCA2, TNBC
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RomidepsinDrug

    Also called Histone deacetylase inhibitor

    Histone deacetylase inhibitor

  • CisplatinDrug

    Also called Platinol

    Platinum compound

  • NivolumabDrug

    Also called Opdivo

    Monoclonal antibody, checkpoint inhibitor

Study groups in NCT02393794
Study groupRoleWhat they receive
Romidepsin (8mg/m2) + Cisplatin (75mg/m2)ExperimentalRomidepsin 8mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle
Receives: Drug: Romidepsin; Drug: Cisplatin
Romidepsin (10mg/m2) + Cisplatin (75mg/m2)ExperimentalRomidepsin 10mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle
Receives: Drug: Romidepsin; Drug: Cisplatin
Romidepsin (12mg/m2) + Cisplatin (75mg/m2)ExperimentalRomidepsin 12mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle
Receives: Drug: Romidepsin; Drug: Cisplatin
Romidepsin Dose ExpansionExperimentalRomidepsin maximum tolerated dose (MTD) from Phase I IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle Nivolumab 360mg on day 1 of each 21 day cycle
Receives: Drug: Romidepsin; Drug: Cisplatin; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Recommended Phase II Dose of romidepsin in combination with cisplatin

    Measured: 12 months

  2. Phase II: Objective response rate of treated subjects according to RECIST v1.1 criteria

    Measured: 24 months

Secondary outcomes (4)

  1. Phase II: Clinical Benefit Rate at 16 weeks of study treatment for subjects treated at the recommended phase II dose of romidepsin plus cisplatin and nivolumab

    Measured: 24 months

  2. Pharmacokinetics - romidepsin plasma concentration vs time profile when given with cisplatin and nivolumab

    Measured: 12 months

  3. Pharmacokinetics - cisplatin plasma concentration vs time profile when given with romidepsin

    Measured: 12 months

  4. Median Progression-Free Survival and Overall Survival

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study start17 Jul 2015
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02393794
Sponsor's protocol ID
IIT-2014-CISRomiNivoTNBC
Other IDs
RM-CL-BRST-PI-002783, IIT-2014-PS-BRST-CISRomiTNBC
Status last verified
Sep 2025
First submitted
13 Mar 2015
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Romidepsin, Cisplatin and Nivolumab in people with Triple-Negative Breast Cancer and Breast Cancer, run by Priyanka Sharma at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Recommended Phase II Dose of romidepsin in combination with cisplatin (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02393794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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