Study of MK-3475 in Participants With Advanced Solid Tumors (MK-3475-012)

Status: Recruiting
Diagnosis: Kidney Cancer, Head and Neck Cancer
NCT ID: NCT01848834 (View complete trial on
DFCI Protocol ID: 13-110


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, or advanced urothelial cancer.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Robert Haddad, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068,
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514,
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264,

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 Exclusion Criteria: - Currently participating in/has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment - Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment - Monoclonal antibody treatment within 4 weeks prior to study Day 1 or not recovered from adverse events due to agents administered more than 4 weeks earlier - Chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent - Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease or documented history of autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents - Evidence of interstitial lung disease - Active infection requiring systemic therapy - Known psychiatric or substance abuse disorders - Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment - Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand 1(PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody - Known history of human immunodeficiency virus (HIV)
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