A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)
Condition: Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: Pembrolizumab Pre-Resection; Surgical Resection; Pembrolizumab Post-Resection
Intervention description: 200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles; Standard of care surgical resection of RCC tumor; 200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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