a study evaluating the effect of pembrolizumab (mk-3475) in participants with renal cell cancer (mk-3475-031)

Conditions: Renal Cell Cancer

Summary: this study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (mk-3475) on tumors of participants with renal cell cancer (rcc). the primary hypotheses are that pembrolizumab is well tolerated in participants undergoing rcc tumor resection; and that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic infiltration in at least 30% of participants with rcc.


Eligibility criteria:
inclusion criteria: * have a newly diagnosed rcc, with a primary tumor diameter of more than 4 cm (\>= t1b), not previously treated, and be a candidate for operative tumor resection * be willing and able to undergo pre-treatment baseline image-guided core biopsy of their primary rcc * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance scale * demonstrate adequate organ function * female is not breast feeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use two acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment * male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw. exclusion criteria: * is currently participating in, or has participated in a study with an investigational agent or device within 4 weeks prior to first dose of study therapy * has a diagnosis of immunosuppression or has received systemic steroid therapy, or any other form of immunosuppressive therapy within 4 weeks prior to first dose of study therapy * has had prior chemotherapy, targeted small molecule, or radiation therapy for treatment of rcc * has a known additional (other than rcc) malignancy that is progressing or requires active treatment * has known active central nervous system (cns) metastases and/or carcinomatous meningitis * has an active, or documented history of autoimmune disease, with the exceptions of vitiligo or resolved childhood asthma/atopy * has a history of (non-infectious) pneumonitis that required treatment with steroids or current pneumonitis. * has an active infection requiring systematic therapy * is receiving anticoagulant therapy, with the exception of low dosage aspirin * has severe cardiovascular disease or symptomatic ischemic heart disease * has hepatic decompensation * has uncontrolled thyroid dysfunction * has uncontrolled diabetes mellitus * has known psychiatric or substance abuse disorders * female is pregnant or breastfeeding * is expecting to conceive children within the projected maximum duration of the trial, extending through 120 days after the last dose of treatment or the last blood draw * has received prior therapy with any antibody or drug (including ipilimumab) specifically targeting t-cell co-stimulation or checkpoint pathway * has a known history of human immunodeficiency virus (hiv) * has known active hepatitis b or c * has received a live vaccine within 30 days prior to screening