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

Conditions

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

Age:
Gender:
Both

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
Sponsor:
Merck
Dates:
08/28/2013
Last Updated:
Study HIC#:
1306012177