Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05012371
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • 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

  • Cabozantinib — DRUG
    Given PO
  • Everolimus — DRUG
    Given PO
  • Lenvatinib — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial compares the effects of lenvatinib given in combination with everolimus to the effects of cabozantinib given alone in treating patients with renal cell cancer (RCC) that has spread to other parts of the body (metastatic) and that got worse on a previous PD-1/PD-L1 checkpoint inhibitor. Lenvatinib, everolimus, and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Feb 16, 2022
Status verified
Mar 2026
Primary completion
Oct 25, 2027
Completion
Oct 25, 2027

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (lenvatinib, everolimus)
    Patients receive lenvatinib PO QD and everolimus PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm B (cabozantinib)
    Patients receive cabozantinib PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Time from start of study drug until disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed up to 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
M D Anderson Cancer CenterHoustonTexas77030-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLM D Anderson Cancer Center· Houston, TXUniversity of Virginia· Charlottesville, VA

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