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

Part of paid clinical trials in Fairway, Kansas.

Sponsor
Priyanka Sharma
Study ID
NCT02393794
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Romidepsin — DRUG
    Histone deacetylase inhibitor
  • Cisplatin — DRUG
    Platinum compound
  • Nivolumab — DRUG
    Monoclonal antibody, checkpoint inhibitor

Study Details

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 Dates

Start date
Jul 17, 2015
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Romidepsin (8mg/m2) + Cisplatin (75mg/m2)
    Romidepsin 8mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle
  • Experimental: Romidepsin (10mg/m2) + Cisplatin (75mg/m2)
    Romidepsin 10mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle
  • Experimental: Romidepsin (12mg/m2) + Cisplatin (75mg/m2)
    Romidepsin 12mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle
  • Experimental: Romidepsin Dose Expansion
    Romidepsin 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

Primary Outcome Measure

Phase I: Recommended Phase II Dose of romidepsin in combination with cisplatin [ Time Frame: 12 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer Center - Clinical Research CenterFairwayKansas66205-
University of Kansas Cancer Center - WestKansas CityKansas66112-
University of Kansas Cancer Center - Overland ParkOverland ParkKansas66210-
University of Kansas Cancer Center - WestwoodWestwoodKansas66205-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - SouthKansas CityMissouri64131-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-

Find similar trials in Fairway, KS

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Kansas Cancer Center - Clinical Research Center· Fairway, KSUniversity of Kansas Cancer Center - West· Kansas City, KSUniversity of Kansas Cancer Center - Overland Park· Overland Park, KSUniversity of Kansas Cancer Center - Westwood· Westwood, KSUniversity of Kansas Cancer Center - North· Kansas City, MOUniversity of Kansas Cancer Center - South· Kansas City, MO

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