A Phase Ib Multi-Cohort Study of MK-3475 in Subjects with Advanced Solid Tumors
Trial Purpose and Description
This study is being done to investigate the safety, tolerability and anti-tumor activity of MK-3475 in participants with advanced triple negative breast cancer (TNBC), advanced head and neck cancer, advanced urothelial cancer, or advanced gastric cancer.
Histologically or cytologically-confirmed diagnosis of tumor that is recurrent, metastatic, or persistent:
- For Cohort A - triple negative breast cancer (estrogen, progesterone, and human epidermal growth factor receptor 2 [HER2] negative)
- For Cohort B - squamous cell carcinoma of the head and neck (including HPV-positive head and neck squamous cell cancer).
- For Cohort C - urothelial tract cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell or non-transitional cell histology)
- Any number of prior treatment regimens
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
- Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study treatment
- Last Updated:
- Study HIC#: