Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2018
Start Date:September 30, 2016
End Date:March 19, 2020
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427)

The purpose of this study is to assess the safety and efficacy of monotherapy pembrolizumab
(MK-3475) in participants with renal cell carcinoma (RCC). There will be two cohorts in this
study: Cohort A will consist of participants with clear cell (cc) RCC and Cohort B will
consist of participants with non-clear cell (ncc) RCC.


Inclusion Criteria:

- Cohort A (clear cell RCC cohort) participant must have histologically confirmed
diagnosis of clear cell RCC or RCC with clear cell component (with or without
sarcomatoid features).

- Cohort B (non-clear cell RCC cohort) participant must have histologically confirmed
diagnosis of non-clear cell RCC (with or without sarcomatoid features). Participants
with tumors that have a component of clear cell histology are not eligible for
inclusion in Cohort B.

- Has locally advanced/metastatic disease, i.e., newly diagnosed Stage IV RCC per
American Joint Committee on Cancer (AJCC) or have recurrent disease.

- Has measurable disease per RECIST 1.1 as assessed by BICR.

- Has received no prior systemic therapy for advanced RCC. Prior neoadjuvant/adjuvant
therapy for RCC is acceptable if completed >12 months prior to allocation.

- Must provide adequate tissue for biomarker analysis for Cohorts A and B from an
archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
not previously irradiated.

- Participants receiving bone resorptive therapy (including but not limited to
bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior
to treatment allocation.

- Has Karnofsky Performance Status (KPS) ≥70%, as assessed within 10 days prior to
treatment allocation.

- Demonstrates adequate organ function.

- Female participants of childbearing potential must be willing to use an adequate
method of contraception for the course of the study through 120 days after the last
dose of study drug.

- Male participants of childbearing potential must agree to use an adequate method of
contraception starting with the first dose of study drug through 120 days after the
last dose of study drug.

Exclusion Criteria:

- Is currently participating in or has participated in a study of an investigational
agent or using an investigational device within 4 weeks prior to allocation, has had
major surgery within 4 weeks or radiation therapy within 2 weeks prior to allocation,
or who has not recovered (i.e., ≤ Grade 1 or to Baseline) from AEs due to prior
treatment.

- Had prior treatment with any anti-programmed cell death 1 (anti-PD-1), or
anti-programmed cell death ligand 1 (PD-L1), or PD-L2 agent or an antibody targeting
any other immune-regulatory receptors or mechanisms. Examples of such antibodies
include antibodies against indoleamine-2,3-dioxygenase (IDO), PD-L1, interleukin 2
receptors (IL-2R), glucocorticoid-induced tumor necrosis factor receptor-related
protein (GITR).

- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy
exceeding 10 mg daily dose of prednisone or equivalent or any other form of
immunosuppressive therapy within 7 days prior to allocation, except in the case of
central nervous system (CNS) metastases (see below).

- Has an active autoimmune disease requiring systemic treatment within the past 2 years
OR a documented history of clinically severe autoimmune disease.

- Has a known additional malignancy that has had progression or has required active
treatment in the last 3 years.Note: Basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ, such as breast cancer in situ, that has
undergone potentially curative therapy are acceptable.

- Has known active CNS metastases and/or carcinomatous meningitis.

- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis.

- Has an active infection requiring systemic therapy.

- Has a known history of Human Immunodeficiency Virus (HIV) infection.

- Has known history of Hepatitis B or known active Hepatitis C.

- Has received a live virus vaccine within 30 days of allocation.

- Has had a prior solid organ transplant.

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study drug.
We found this trial at
19
sites
1854
mi
from 43215
Kennewick, WA
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1344
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from 43215
Billings, MT
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643
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from 43215
Boston, MA
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590
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from 43215
Burlington, VT
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Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
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362
mi
from 43215
Chattanooga, TN
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274
mi
from 43215
Chicago, IL
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163
mi
from 43215
Detroit, MI
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1767
mi
from 43215
Las Vegas, NV
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993
mi
from 43215
Miami, FL
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335
mi
from 43215
Milwaukee, WI
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798
mi
from 43215
New Orleans, LA
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481
mi
from 43215
New York, NY
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416
mi
from 43215
Philadelphia, PA
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2 Svornosti
Prague, 150 00
Phone: 420 233 010 111
4463
mi
from 43215
Prague,
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251
mi
from 43215
Roanoke, VA
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2107
mi
from 43215
San Francisco, CA
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1639
mi
from 43215
Tucson, AZ
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328
mi
from 43215
Washington,
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