A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)

• Status: Terminated
• Trial end date: 2019-07-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

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