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
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab
- Conditions
- Carcinoma Breast Stage IV
- Sponsor
- Fox Chase Cancer Center
- Enrollment
- 87
- Locations
- 6
- Primary Endpoint
- Objective Response Rate
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Pembrolizumab with Standard Chemotherapy
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
Intervention: Pembrolizumab
Pembrolizumab with Standard Chemotherapy
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
Intervention: Carboplatin
Pembrolizumab with Standard Chemotherapy
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
Intervention: Gemcitabine
Standard Chemotherapy Alone
Standard chemotherapy alone using carboplatin and gemcitabine.
Intervention: Carboplatin
Standard Chemotherapy Alone
Standard chemotherapy alone using carboplatin and gemcitabine.
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: Up to 24 months
Evaluate antitumor activity by assessing the percentage of patients with evidence of complete response or partial response per RECIST 1.1 criteria.
Incidence of Treatment-Related Adverse Events
Time Frame: From the first dose of study treatment until 30 days after discontinuation of study treatment.
The safety and tolerability of Pembrolizumab in Combination with Carboplatin and Gemcitabine will be evaluated from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results.
Secondary Outcomes
- Progression Free Survival(From the start of treatment until progressive disease or date of death, whichever occurs first (assessed up to 60 months.))
- Overall Survival(From the start of treatment until death (assessed up to 60 months.))
- Clinical Benefit Rate(Up to 24 months)