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

NCT02212730 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-16

Study results available
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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.

Conditions

  • Renal Cell Cancer

Interventions

DRUG

Pembrolizumab Pre-Resection

200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles

PROCEDURE

Surgical Resection

Standard of care surgical resection of RCC tumor

DRUG

Pembrolizumab Post-Resection

200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-03
Primary Completion
2019-07-05
Completion
2019-07-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02212730 on ClinicalTrials.gov