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A Single Arm, Multicenter, Phase 2 Trial to Evaluate the Efficacy of Lenvatinib (LEN) in Combination with Pembrolizumab (KEYtruda) in Subjects with Locally Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (The LENKYN Trial)

Clinical Trial Details

This is a research study for adults diagnosed with non-clear cell renal cell carcinoma that has spread outside the kidneys, but they have not yet received any treatment since the disease spread.
   
The purpose of this study is to look at the combination of two drugs, lenvatinib and pembrolizumab, to see how they work together to treat non-clear cell renal cell carcinoma. The study will also look at the side effects participants experience with this combination of drugs.
   
Pembrolizumab is approved by the U.S. Food and Drug Administration (FDA) in combination with axitinib, to treat many different kinds of cancer, including renal cell carcinoma).
   
Lenvatinib is approved by the FDA to treat thyroid cancer, advanced renal cell carcinoma (in combination with everolimus), hepatocellular carcinoma, and endometrial carcinoma (in combination with pembrolizumab).
   
The use of pembrolizumab and lenvatinib is considered investigational in this study because the combination has not yet been approved by the FDA for this purpose.
   
People enrolling in this study will receive pembrolizumab intravenously once every three weeks for up to 2 years and will take lenvatinib by mouth every day. Regular physical exams and blood draws will be performed for safety purposes. Additionally, tumor tissue and blood will be collected for research purposes.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with non-clear cell renal cell carcinoma that has spread outside the kidneys.
  2. Has not received any prior lines of full body therapy since the cancer has spread.  

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2011022950

ClinicalTrials.gov:

NCT04267120

Sponsor:

The LENKYN Trial

Status

Open to Enrollment

Age Group

Adult

Sponsor