Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Washington University School of Medicine
Study ID
NCT04267120
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    Lenvatinib will be provided by Merck.
  • Pembrolizumab — DRUG
    Merck will provide pembrolizumab
  • Research blood collection — PROCEDURE
    -Within 2 weeks prior to first dose of study drug, cycle 4 day 1, and at the off-treatment assessment

Study Details

This is a single-arm, multicenter, phase 2 study of lenvatinib in combination with pembrolizumab (lenvatinib 20 mg/day + pembrolizumab 200mg q3weeks) in subjects with unresectable advanced or metastatic non-clear cell renal carcinoma who have not received any chemotherapy for advanced disease.

Key Dates

Start date
Jul 29, 2020
Status verified
Mar 2025
Primary completion
May 9, 2024
Completion
Sep 1, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib + Pembrolizumab
    * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Through completion of treatment (median length 287 days, full range 92-728 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterPalo AltoCalifornia94306-
Washington University School of MedicineSt LouisMissouri63110-

Related coverage on Hipa.ai

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