Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04393350
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Kidney Cancer
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Lenvatinib — DRUG
    Given PO
  • Lenvatinib Mesylate — DRUG
    Given PO
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial studies how well lenvatinib and pembrolizumab before surgery work in treating patients with kidney cancer that has spread from its original site of growth to nearby tissues or lymph nodes but has not spread to other places in the body (non-metastatic). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib and pembrolizumab before surgery may kill more tumor cells.

Key Dates

Start date
Jun 22, 2020
Status verified
Mar 2026
Primary completion
Sep 13, 2024
Completion
Dec 11, 2026

Study Design

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

Arms

  • Experimental: Treatment (lenvatinib, pembrolizumab)
    Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (Complete and Partial Responses) [ Time Frame: Baseline until end of Cycle 1 (4 Cycles (12 weeks) ]

Locations (1)

FacilityCityStateZIP
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322

Related coverage on Hipa.ai

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By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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