Trials / Active Not Recruiting
Active Not RecruitingNCT02755272
A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- Sponsor
- Fox Chase Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer. Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | IV Infusion of 200 mg given on day one of each 21 day treatment cycle. |
| DRUG | Carboplatin | IV infusion of a calculated dose (AUC 2 mL/min) given on days one and eight of each 21 day treatment cycle. |
| DRUG | Gemcitabine | IV infusion of 800 mg/m\^2 given on days one and eight of each 21 day treatment cycle. |
Timeline
- Start date
- 2016-05-31
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2016-04-28
- Last updated
- 2025-07-04
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02755272. Inclusion in this directory is not an endorsement.