Study of MK-3475 in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT02054806 (View complete trial on
DFCI Protocol ID: 14-026


This study will assess the efficacy and safety of MK-3475 administered to participants with advanced biomarker-positive solid tumors that have not responded to current therapy, for which current therapy is not appropriate, or for which no current therapy exists. The hypothesis is that administration of MK-3475 to participants with some types of solid tumors will result in a clinically meaningful response rate.


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

Overall PI:
Patrick Ott, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623,

Eligibility Criteria

Inclusion criteria: - Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy that has failed prior standard therapy or for which standard therapy is not appropriate, or for which no standard therapy exists - Have biomarker-positive solid tumor - Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 - Adequate organ function - 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 medication - 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 therapy Exclusion Criteria: - Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment - Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment - Prior anti-cancer therapy with a monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from adverse events due to mAbs administered more than 4 weeks earlier - Prior 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 that has undergone potentially curative therapy, or in situ cervical cancer - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents - Evidence of interstitial lung disease - Active infection requiring systemic therapy - Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - 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-PD-1, anti-PD-L1, and anti-PD-L2 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) - Known history of human immunodeficiency virus (HIV) - Known active Hepatitis B or Hepatitis C
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