A Phase Ib Multi-Cohort Study of MK-3475 in Subjects with Advanced Solid Tumors


Bladder | Breast - Female | Lip, Oral Cavity and Pharynx | Stomach

Trial Phase

Phase IB

Trial Purpose and Description

Trial Purpose

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.

Participation Guidelines


Eligibility Criteria

Inclusion Criteria:

  • 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
Merck Sharp & Dohme
Last Updated:
Study HIC#: