OncoMatch/Clinical Trials/NCT02977468
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
Is NCT02977468 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Merck 3475 Pembrolizumab for triple negative breast cancer.
Treatment: Merck 3475 Pembrolizumab — Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC) patients. Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative by IHC (≤10%) (≤10%)
triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2 negative by IHC and FISH). Patients who are weekly positive for the estrogen or progesterone receptor (i.e., < or = 10%) are eligible.
Required: PR (PGR) negative by IHC (≤10%) (≤10%)
triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2 negative by IHC and FISH). Patients who are weekly positive for the estrogen or progesterone receptor (i.e., < or = 10%) are eligible.
Required: HER2 (ERBB2) negative by IHC and FISH
triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2 negative by IHC and FISH)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
Cannot have received: radiation therapy
Exception: within 6 months of study entry
No prior anti-cancer therapy including investigational agents, radiation therapy, or breast resection within 6 months of study entry.
Cannot have received: surgery
Exception: breast resection within 6 months of study entry
No prior anti-cancer therapy including investigational agents, radiation therapy, or breast resection within 6 months of study entry.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University · Atlanta, Georgia
- Loyola University Chicago · Maywood, Illinois
- Columbia University Irving Medical Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT02977468 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 negative by IHC (≤10%) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative by IHC (≤10%) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative by IHC and FISH is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger and at least 21 years old.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify