NCT02393794

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Priyanka Sharma · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Triple-Negative Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Romidepsin	Histone deacetylase inhibitor
DRUG	Cisplatin	Platinum compound
DRUG	Nivolumab	Monoclonal antibody, checkpoint inhibitor

Timeline

• Start date: 2015-07-17
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2015-03-19
• Last updated: 2025-10-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study